[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ANRS, Emerging Infectious Diseases\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":687},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,42,74,111,150,178,205,228,253,290,317,338,362,390,418,440,464,489,519,544,566,591,619,641,663],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100470223","phase-4-efficacy-of-tenofovir-disoproxil-on-mother-to-child-transmission-of-hbv-in-tokombr-cameroon-in-pregnant-women-100470223",false,"NCT05403047","Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women","Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women Infected With Hepatitis B Virus (HBeAg Positive or With a High Viral Load) and Whose Newborns Had Been Vaccinated at Birth","TOPCHIB","Inclusion criteria:\n\n* Pregnant women with a term of less than 24 weeks of amenorrhea;\n* HBsAg positive ;\n* HBeAg positive or HBeAg negative with a high viral load ( \\> 200 000 UI\u002Fml) ;\n* 16 years old or more on the inclusion day ;\n* Signature of free and informed consent (for pregnant women aged 16 to 21, the participant's consent as well as the authorization of a parent\u002Fadult husband\u002F legal tutor will be collected) which also includes consent for the children\n\nExclusion criteria :\n\n* HIV co-infection;\n* Women treated for HBV;\n* Creatinine clearance \\\u003C30 ml \u002F min;\n* Suspicion of poor monitoring of children's vaccination schedule for HBV (vaccination at birth + boosters);\n* Disease or treatment contraindicating the taking of TDF.","FEMALE","16 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate (TDF) from the 28th week of amenorrhoea until 6 weeks after delivery. Their newborns will receive the hepatitis B vaccine, starting with one dose at birth and followed by three booster doses, according to the Expanded Programme on Immunisation.\n\nThe investigators hypothesise that a short course of TDF could greatly reduce the risk of HBV MTCT in pregnant women at high risk of MTCT (HBeAg positive or with high viral load).",[28],"Hepatitis B Virus - Chronic Active","RECRUITING","2026-06-25",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2023-08-22",{"date":37,"type":22},"2028-02",{"name":39,"class":40},"ANRS, Emerging Infectious Diseases","OTHER_GOV",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100373655","phase-3-intensified-tuberculosis-treatment-to-reduce-the-mortality-of-patients-with-tuberculous-meningitis-100373655","NCT04145258","Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis","Intensified Tuberculosis Treatment to Reduce the Mortality of HIV-infected and Uninfected Patients With Tuberculosis Meningitis: a Phase III Randomized Controlled Trial (Acronym: INTENSE-TBM)","INTENSE-TBM","Inclusion criteria:\n\n1. Age ≥ 15 years\n2. TBM defined as \"definite\", \"probable\" or \"possible\"\n3. Signed Informed Consent\n\n   * Definite TBM = at least one of the following criteria: acid-fast bacilli seen in CSF microscopy, positive CSF M. tuberculosis culture, or positive CSF M. tuberculosis commercial nucleic acid amplification test.\n   * Probable TBM = total modified Marais score ≥12 when neuroimaging is available, or ≥10 when neuroimaging is not available (at least 2 points should come from CSF or cerebral imaging criteria).\n   * Possible TBM = total modified Marais 6-11 when neuroimaging is available, or 6-9 when neuroimaging is not available.\n\nExclusion criteria:\n\n* \\> 5 days of TB treatment\n* Renal failure (eGFR\\\u003C30 ml\u002Fmin, CKD-EPI formula).\n* Neutrophil count \\\u003C 0.6 x 109\u002FL.\n* Hemoglobin concentration \\\u003C 8 g\u002FdL.\n* Total bilirubin \\> 2.6 times the Upper Limit of Normal\n* Platelet count \\\u003C 50 x 109\u002FL.\n* ALT \\> 5 times the Upper Limit of Normal.\n* Clinical evidence of liver failure or decompensated cirrhosis.\n* For women: more than 17 weeks pregnancy or breastfeeding.\n* For patients without decrease level of consciousness (Glasgow Coma Scale = 15): Peripheral neuropathy scoring Grade 3 or above on the Brief Peripheral Neuropathy Score (BPNS).\n* Documented M. tuberculosis resistance to rifampicin.\n* Positive gram-stain, bacterial culture or cryptococcal antigen in the Cerebral Spinal Fluid.\n* Evidence of active bleeding (hemoptysis, gastrointestinal bleeding, hematuria, intracranial bleeding).\n* Inability to collect Cerebral Spinal Fluid, except for patients with confirmed tuberculosis (by rapid molecular test or culture) from another biological sample and clinical and\u002For CT scan evidence of meningitis.\n* Major surgery within the last two weeks prior to inclusion.\n* Ongoing chronic aspirin treatment (eg for cardiovascular risk).\n* Current use of drugs contraindicated with study drugs and that cannot be safely stopped (see Appendix 1: Drugs contra-indicated with study drugs).\n* In available history from patients:\n\n  * Evidence of past intracranial bleeding.\n  * Evidence of past of peptic ulceration.\n  * Evidence of recent (\\\u003C 3 month) gastrointestinal bleeding.\n  * Known hypersensitivity contraindicating the use of study drugs .\n  * Evidence of porphyria.\n  * Evidence of hyperuricemia or gout.\n* Any reason which at the discretion of the investigator would compromise safety and cooperation in the trial.","ALL","15 Years",{"count":53,"type":22},768,[55],"PHASE3","INTENSE-TBM is randomized controlled, phase III, multicenter, 2 x 2 factorial plan superiority trial assessing the efficacity of two interventions to reduce mortality from tuberculous meningitis (TBM) in adolescents and adults with or without HIV-infection in sub-Saharan Africa:\n\n* Intensified TBM treatment with high-dose rifampicin and linezolid, compared to WHO standard TBM treatment.\n* Aspirin, compared to not receiving aspirin. The trial will be open-label for anti-TB treatment and placebo-controlled for aspirin treatment.",[58],"Tuberculous Meningitis",[58,60,61,62,63,64],"Intensified treatment","High dose Rifampicin","Linezolid","Aspirin","Subsaharan Africa","2026-06-21",{"date":67,"type":33},"2026-06-24",{"date":69,"type":33},"2021-02-07",{"date":71,"type":22},"2026-09-26",{"name":39,"class":40},13,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100641318","intestinal-tissue-resident-memory-t-cells-and-hiv-1-persistence-during-antiretroviral-therapy-100641318","NCT07656077","Intestinal Tissue-Resident Memory T Cells and HIV-1 Persistence During Antiretroviral Therapy","Intestinal Tissue-Resident Memory T Cells in HIV-1 Infection: Mechanisms Involved in Their Depletion and Role in Viral Persistence During Antiretroviral Therapy","ANRSGALT-2","I - Inclusion criteria\n\n1 - Group 1: People Living With HIV-1\n\n* Age ≥ 18 years\n* Documented HIV-1 infection\n* Continuous suppressive antiretroviral therapy initiated during chronic infection for at least 12 months\n* Plasma HIV-1 RNA ≤ 50 copies\u002FmL for at least 6 months under ART (one isolated blip ≤ 200 copies\u002FmL allowed)\n* Blood CD4+ T-cell count ≥ 350 cells\u002Fmm³\n* Clinically indicated colonoscopy independent of the research protocol\n* Affiliation with a social security system\n* Written informed consent obtained before any study-specific procedure\n\n  2- Group 2: HIV-Seronegative Controls\n* Age ≥ 18 years\n* HIV-seronegative status\n* Clinically indicated colonoscopy independent of the research protocol\n* Affiliation with a social security system\n* Written informed consent obtained before any study-specific procedure\n\nII - Exclusion Criteria\n\n1. Group 1: People Living With HIV-1\n\n   * HIV-2 infection\n   * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease\n   * Platelet count \\\u003C 50 G\u002FL or uncorrectable coagulation disorders contraindicating biopsies\n   * Decompensated cirrhosis\n   * History of lymphoma\n   * Participation in an HIV vaccine or immunotherapy study\n   * Pregnant or breastfeeding women\n   * Participation in another clinical study with an ongoing exclusion period\n   * Vulnerable individuals, including minors, individuals under guardianship, or persons deprived of liberty\n2. Group 2: HIV-Seronegative Controls\n\n   * HIV-1 or HIV-2 infection\n   * Refusal to undergo HIV serology testing\n   * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease\n   * Platelet count \\\u003C 50 G\u002FL or uncorrectable coagulation disorders contraindicating biopsies\n   * Decompensated cirrhosis\n   * History of lymphoma\n   * Pregnant or breastfeeding women\n   * Participation in another clinical study with an ongoing exclusion period\n   * Vulnerable individuals, including minors, individuals under guardianship, or persons deprived of liberty",true,"18 Years",{"count":85,"type":22},30,[87],"NA","The study aims to better characterize intestinal tissue-resident memory T cells (TRM) in people living with HIV-1 receiving suppressive antiretroviral therapy (ART). TRM cells are key components of tissue immunity and may contribute to HIV-1 persistence within the intestinal mucosa, a major viral reservoir. The phenotypic, transcriptomic, and functional characteristics of intestinal CD4+ and CD8+ TRM cells, their susceptibility to HIV-1 infection, and their potential role as viral reservoirs will be investigated. Blood samples and additional colonic biopsies obtained during routine clinically indicated colonoscopy will be collected from HIV-1-infected participants and HIV-seronegative controls.",[90,91,92],"HIV-1 Infection","HIV Reservoir","Antiretroviral Therapy",[94,95,96,97,98,99,100,101],"HIV-1","Tissue-Resident Memory T Cells","Viral Reservoir","ART","Intestinal Mucosa","Mucosal Immunity","CD4 T Cells","HIV Persistence","NOT_YET_RECRUITING","2026-06-14",{"date":105,"type":33},"2026-06-18",{"date":107,"type":22},"2026-08-01",{"date":109,"type":22},"2030-07-31",{"name":39,"class":40},{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":119,"targetDuration":121,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100584776","prospective-cohort-of-people-starting-treatment-for-tuberculosis-disease-in-france-frenchtb-100584776","NCT06893757","Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France (FrenchTB)","Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France - ANRS 464s FrenchTB","FrenchTB","Inclusion Criteria:\n\n* Aged ≥18 years.\n* Diagnosis of tuberculosis by microbiological or clinical means, including on the basis of a pathological examination for extrapulmonary tuberculosis leading to a Compulsory Declaration (CD) and treated for less than 8 days.\n* Have signed a voluntary, informed and written consent (at the latest on the day of inclusion and before any examination carried out as part of the research), or alternatively, consent from relatives in cases of tuberculous meningitis or other serious forms of tuberculosis with impaired consciousness or confusion, until the person is able to give their consent.\n\nExclusion Criteria:\n\n* Presence of significant cognitive impairment that, in the opinion of the site investigator or designated person, may affect the ability to give reliable informed consent (except in the specific case of meningeal tuberculosis).",{"count":120,"type":22},2000,"5 Years","OBSERVATIONAL","The French Tuberculosis Cohort is a prospective, national, multicenter, low-intervention study including subjects aged 18 years and older with tuberculosis disease for which inpatient treatment is initiated. The goal of this observational study is to follow-up and anti-tuberculosis treatment will be provided according to current French recommendations. Participants will provide sociodemographic, clinical, biological, radiological and bacteriological data at various protocol visits at 2 days, 1 and 2 weeks, 2 months, at the end of treatment, 12 and 24 months. Consenting participants will have samples collected at scheduled visits for the establishment of a biobank. This will include blood, urine, breath and hair samples. The positive mycobacterial strains will constitute a specimen bank.",[125],"Tuberculosis",[127,128,129,130,131,132,133,134,135,136,137,138,139,140],"infectious diseases","tuberculosis","clinical","social sciences","public health","Comorbidities","epidemiology","Treatment and care","Transmission","France","biobank","mycobacterial collection","cohort","prospective","2026-06-10",{"date":143,"type":33},"2026-06-12",{"date":145,"type":33},"2026-05-06",{"date":147,"type":22},"2031-06",{"name":39,"class":40},2,{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":82,"sex":50,"minAge":83,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100637917","early-phase-1-an-experimental-medicine-multicenter-trial-to-evaluate-the-safety-and-immunogenicity-of-experimental-versus-authorized-sars-cov-2-vaccine-candidates-as-a-booster-dose-in-healthy-participants-previously-vaccinated-with-authorized-mrna-sars-cov-2-vaccines-100637917","NCT07605520","An Experimental Medicine Multicenter Trial to Evaluate the Safety and Immunogenicity of Experimental Versus Authorized SARS-CoV-2 Vaccine Candidates as a Booster Dose in Healthy Participants Previously Vaccinated With Authorized mRNA SARS-CoV-2 Vaccines.","SOLVE-01","Inclusion Criteria:\n\n1. Male and female subjects aged 18 to 65 years inclusive at the time of the screening visit\n2. Having received at least two doses of COVID-19 mRNA vaccines in the past with the last dose received more than 6 months prior to IMP administration in the trial\n3. In healthy condition or with stable health status which is defined as an existing disease that has not required a significant change in treatment or hospitalization for worsening before enrolment, and for which neither a significant change in treatment or hospitalization for worsening is expected in the near future.\n4. For woman of childbearing potential: a negative Beta-HCG blood test measure during the screening visit, and a negative highly sensitive pregnancy urinary test the day of the vaccination visit\n\n   * if heterosexually active female, consistently using a highly effective method of contraception with partner from at least 21 days prior to enrolment through 4 months after the IMP administration. Highly effective contraception is defined as using any of the following methods:\n\n     * Combined hormonal contraception with inhibition of ovulation (estrogen and progesterone containing);\n     * Intrauterine device (IUD);\n     * Intrauterine hormone releasing system (IUS);\n     * Hormonal contraception (progesterone only);\n     * Successful vasectomy in the male partner (considered successful if a participant reports that a male partner has (i) documentation of azoospermia by microscopy, or (ii) a vasectomy more than 2 years ago with no resultant pregnancy despite unprotected sexual activity post vasectomy);\n     * Or not be of reproductive potential, such as having reached menopause (no menses for 1 year without an alternative medical cause) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation.\n   * Agree not to seek pregnancy including through alternative methods, such as artificial insemination or in vitro fertilization until 4 months after the IMP administration.\n5. Participant who was born male, if heterosexually active male, using an effective method of contraception with their partner from the IMP administration until 4 months thereafter. All male participants also agree not to donate sperm during this period.\n6. Negative nasopharyngeal antigenic test for SARS-CoV-2 on the day of screening and before randomisation\n7. Participant who has normal biological values:\n\n   * Hemoglobin ≥ 11.0 g\u002FdL for participants who were born female, ≥ 13.0 g\u002FdL for participants who were born male;\n   * White blood cell count = 3,300 to 12,000 cells\u002Fmm3;\n   * Total lymphocyte count ≥ 800 cells\u002Fmm3;\n   * Platelets = 125,000 to 550,000\u002Fmm3;\n   * ALT, AST, and alkaline phosphatase \\\u003C 1.25 times the institutional upper limit of normal;\n   * Creatinine \\\u003C1.1x institutional upper limit of normal of the laboratory;\n   * Normal urine test: absence of glucose, protein and haemoglobin\n   * Negative HIV antigen\u002Fantibody test;\n   * Negative Hepatitis B surface antigen (HBsAg);\n   * Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive;\n8. Willingness to undertake SARS-CoV-2 testing according to study protocol, and receive SARS-CoV-2 test results\n9. Willingness and availability to be followed for the planned duration of the study in one of the dedicated trial centres\n10. Informed and signed written consent form before performance of any trial-related screening procedures\n11. Agree to be registered in the French Health Ministry computerised file (for France only)\n12. Being covered by Health Insurance (for France only)\n\nExclusion Criteria:\n\n1. Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and\u002For presenting symptoms suggestive of COVID-19 or SARS-CoV-2 infection within the previous 28 days or having been in contact with an infected individual for the last 14 days before the inclusion visit\n2. Any medical condition that could impair the immune response: clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:\n\n   * A process that would affect the immune response;\n   * A process that would require medication that affects the immune response;\n   * Any contraindication to repeated injections or blood draws;\n   * A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being during the study period;\n   * A condition or process for which signs or symptoms could be confused with reactions to vaccine, or\n   * Any condition specifically listed among the exclusion criteria below.\n3. Pregnancy or breastfeeding that is currently ongoing, or positive pregnancy test at screening visit and the day of the vaccination\n4. Immunodeficiency\n5. Asthma: a condition that requires active medical intervention or monitoring to avert grave danger to asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a participant who:\n\n   * Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or\n   * Uses moderate\u002Fhigh dose inhaled corticosteroids, or\n   * In the past year has either of the following: (i) Greater than 1 exacerbation of symptoms treated with oral\u002Fparenteral corticosteroids or (ii) Needed emergency care, urgent care, hospitalization, or intubation for asthma.\n6. Diabetes type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes).\n7. Thyroidectomy, or thyroid disease requiring medication during the last 12 months\n8. Hypertension:\n\n   * If a person has been diagnosed with hypertension, exclude for blood pressure that is not well controlled (well-controlled blood pressure is defined as consistently ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic). For these participants, blood pressure must be ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic at enrolment;\n   * If a person has NOT been diagnosed with hypertension, exclude for systolic blood pressure ≥ 150 mm Hg at enrolment or diastolic blood pressure ≥ 100 mm Hg at enrolment. (the measurement must be performed on a person who has been lying down for at least 5 minutes and repeat at the end of the consultation, if appropriated). Tension must be confirmed outside the clinical site to rule out hypertension.\n9. Contraindication to the IMPs including hypersensitivity\n10. BMI ≥ 40 kg\u002Fm2; ≤ 18 kg\u002Fm2; or BMI ≥ 35 kg\u002Fm2 with 2 or more of the following: age \\> 45, systolic blood pressure \\> 140 mm Hg, diastolic blood pressure \\> 90 mm Hg, current smoker, known hyperlipidemia\n11. Bleeding disorder diagnosed (e.g., coagulation factor deficiency, coagulopathy, or platelet disorder requiring special precautions)\n12. Malignancy (Not excluded: volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)\n13. Asplenia: any condition resulting in the absence of a functional spleen\n14. Seizure disorder: History of seizure(s) within past three years. Also excluded if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.\n15. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.\n16. History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including arrhythmia requiring medication, treatment, or clinical follow-up)\n17. History of autoimmune disease\n18. Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence, assessment of safety, or a volunteer's ability to give informed consent\n19. Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.\n20. History of serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and\u002For abdominal pain. (Not excluded: a volunteer who had a non-anaphylactic adverse reaction to pertussis vaccine as a child)\n21. Investigational research agents received within 30 days before IMP administration\n22. Experimental vaccine(s) received within the last 5 years in a prior vaccine trial\n23. Live attenuated vaccines (e.g., measles, mumps, and rubella (MMR); oral polio vaccine (OPV); varicella; yellow fever) received within 30 days before IMP administration or scheduled within 28 days after the injection scheduled within the protocol\n24. Vaccines that are not live attenuated vaccines and were received within 21 days prior to IMP administration (e.g., tetanus, pneumococcal, Hepatitis A or B)\n25. Blood-derived products or immunoglobulin received within 6 months before IMP administration\\*\n26. Current anti-tuberculosis (TB) prophylaxis or therapy received within 3 months before IMP administration \\*\n27. Allergy treatment with antigen injections within 30 days before IMP administration or that are scheduled within 14 days after IMP administration\\*\n28. Immunosuppressive medications or immunomodulators (such as cytokines or interferons) received within last three months before IMP administration. (Not excluded: (1) corticosteroid nasal spray; \\[2\\] topical corticosteroids for mild, uncomplicated dermatitis; or (2) a single course of oral\u002Fparenteral corticosteroids at doses \\\u003C 2 mg\u002Fkg\u002Fday and length of therapy \\\u003C 11 days with completion at least 30 days prior to enrolment) or low dose oral corticosteroids (≤10 mg prednisone\u002Fday) or corticosteroids for the treatment of immune-related adverse events\\*\n29. Other prohibited medications: Corticosteroids \\> 10 mg prednisone equivalent\u002Fday (not excluded: topical preparations) \\*\n30. Person participating in another research involving the human person or participating in another research involving the human person with an exclusion period still in progress at screening\n31. Intent to participate in another study of an investigational research agent during the planned duration of the study\n32. Participants who are not able to understand and to follow all required study procedures for the whole period of the study in the judgment of the investigator\n33. Under tutorship (only for France), guardianship, or deprived of liberty by a juridical or administrative decision\n34. Planned absence that could affect participation in the study (travel abroad, relocation, impending professional mutation...)\n\n    * The scheduled use of these treatments up to 6 months after the injection also represents a contraindication","65 Years",{"count":159,"type":22},48,[161],"EARLY_PHASE1","The SOLVE-01 trial is a study evaluating four SARS-CoV-2 vaccines as booster injections: two experimental vaccines (CD40.RBDv and CD40.Pan.CoV, both combined with the Hiltonol® adjuvant) and two authorised vaccines (Comirnaty® and NuvaxovidTM). This trial is designed for healthy adults aged 18 to 65 at the time of signing the informed consent form.\n\nThe main objectives of this trial are:\n\n* to evaluate the safety of the two experimental vaccines,\n* to determine the antibody response induced by the vaccines and its durability.\n\nParticipants will:\n\n* Receive one injection of vaccine and two intradermal skin tests\n* Come to the hospital 10 visits for medical exams and blood and saliva sample collection\n* Keep a diary of their symptoms and the treatments taken",[164],"Healthy Adults",[166,167,168],"COVID19 vaccine","phase 1","experimental medicine trial","2026-06-01",{"date":171,"type":33},"2026-06-02",{"date":173,"type":33},"2026-05-13",{"date":175,"type":22},"2028-12",{"name":39,"class":40},3,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":4},"100638236","assessment-of-immune-memory---humoral-and-cellular---in-mpox-infected-patients--an-ancillary-study-of-the-anrs0258s-mosaic-cohort-100638236","NCT07592429","Assessment of Immune Memory - Humoral and Cellular - in mPOX-infected Patients : an Ancillary Study of the ANRS0258s MOSAIC Cohort","POXAIM","Inclusion Criteria:\n\n* Written informed consent, signed by the participant and the investigator prior to any study-related procedure\n* Person previously enrolled in the ANR0258s-MOSAIC cohort (see Appendix 19.2 for MOSAIC inclusion criteria) between July 2022 and July 2023\n* Person with a blood sample taken within 8 months following mpox infection\n* ≥ 18 years old\n\nExclusion Criteria:\n\n* Individuals who, in the investigator's opinion, are unlikely to comply with study procedures or whose medical condition is incompatible with study participation\n* For France only: person not affiliated to or not benefiting from a social security scheme in accordance with article L1121-11 of the French Public Health Code (Aide Médicale d'Etat \\[AME\\] does not constitute a social security scheme)\n* Pregnant or breastfeeding women\n* Individuals under guardianship or curatorship, or deprived of liberty by judicial or administrative decision",{"count":186,"type":22},60,[87],"Primary objective The overall objective is to assess the long-term amplitude and durability of the immune responses after mpox virus (MPXV) infection.\n\nPrimary endpoint The main outcomes are: the presence of neutralizing antibodies in the serum and the presence of detectable mpox virus-specific memory B cells. Neutralizing antibodies titers will be measured with a semi-automated cell-based assay using live mpox virus. Memory B cells will be measured by flow cytometry and other techniques.\n\nSecondary objectives\n\n1. Assess the amplitude and the stability of the MPXV antigen-specific B-cell memory response after infection, against the immunodominant antigens A27, A33, B5, L1, D8, and H3.\n2. Assess the breadth of the B-cell repertoire and its neutralizing capacity in a subset of patients\n3. Assess the humoral immunity using different serological techniques, for the detection and quantification of anti-MPXV antibodies, and assess the seroneutralization capacities of each antibody.\n\nSecondary endpoints\n\n1. The presence of MPXV antigen-specific B-cell memory. Memory B cells will be measured by flow cytometry and other techniques.\n2. The breadth and neutralizing capacity of the B-cell repertoire in a subset of patients.\n3. The humoral immunity using serological techniques.",[190],"Mpox (Monkeypox)",[192,193,194,195,196],"mpox virus","Immune protection","Immune response","Immunity duration","Infection","2026-05-14",{"date":199,"type":33},"2026-05-18",{"date":201,"type":22},"2026-07-01",{"date":203,"type":22},"2028-07-01",{"name":39,"class":40},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":41},"100172620","the-anrs-co21--extreme--cohort-codex-100172620","NCT01520844","the ANRS CO21 \" Extreme \" Cohort (CODEX)","Multicentric Cohort of HIV Patient With Extrem Profil","CODEX","Inclusion Criteria:\n\n* Patient infected with HIV-1 and not co-infected with HIV-2\n* Age ≥ 18 at enrollment\n* Able to give written consent\n* Covered by French Social Security\n* accept the constraints imposed by the study\n* without antiretroviral therapy for ALT, HIC and ALT HIC groups and a control of viral load after antiretroviral treatment interruption in PTC group\n\nALT group: Documented HIV-1 seropositive for at least 8 years with a CD4 count above 600\u002Fmm3 with a rate stable or increasing (positive or zero slope) on at least three consecutive examinations performed during the last 5 years regardless of the viral load in the absence of antiretroviral treatment\n\nHIC group: HIV-1 Seropositivity known for at least five years, asymptomatic, with the last 5 viral loads in HIV-RNA consecutive \\\u003C400 copies \u002F mL regardless of CD4 count in the absence of antiretroviral treatment\n\nALT HIC group: HIV-1 seropositive known for at least 8 years and CD4 cell counts greater than 600\u002Fmm3 with a rate stable or increasing (positive or zero slope) on at least three consecutive examinations performed during the last 5 years and with the last 5 viral loads in HIV-RNA consecutive \\\u003C400 copies \u002F mL in the absence of antiretroviral therapy.\n\nPTC group: Patients with plasma HIV RNA \\> 2000 copies\u002FmL before initiation of antiretroviral therapy. Treatment started during the primary infection (as defined by symptoms associated with seroconversion, as confirmed by a first negative ELISA and\u002For an incomplete P24-positive Western blot) or during the chronic phase of infection, and maintained for at least 12 months in both cases. Control of viral load after antiretroviral treatment interruption: patients must have at least two available viral load assays after stopping antiretroviral therapy. All viral loads must be \\\u003C400 copies\u002FmL for 12 months or more after stopping antiretroviral therapy, with the possible exception of one blip (one viral load above 400 copies\u002FmL between two viral loads \\\u003C400 copies\u002FmL at least one month apart from the blip; in this case at least three viral load assays will be required). The last plasma viral load value at the time of inclusion must always be \\\u003C400 copies\u002FmL\n\nExclusion Criteria:\n\nUnder protection(saving) of justice","85 Years",{"count":215,"type":22},450,[87],"A consortium of research teams has studied the immunovirological characteristics of these patients:\n\nThe ANRS CO15 ALT cohort The ANRS CO18 HIV Controller cohort the ANRS EP47 VISCONTI study",[219],"HIV Infection","2026-04-02",{"date":222,"type":33},"2026-04-07",{"date":224,"type":33},"2012-02",{"date":226,"type":22},"2030-09",{"name":39,"class":40},{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":50,"minAge":19,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},"100484427","phase-2-optimisation-of-antiviral-therapy-in-immunocompromised-covid-19-patients-a-randomized-factorial-controlled-strategy-trial-100484427","NCT05587894","OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial","OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the OPTICOV Study","OPTICOV","Inclusion Criteria:\n\n1. Laboratory confirmed SARS-CoV-2 infection by RT-PCR or positive antigenic test (commercialized assay)\n2. Asymptomatic or mild to moderate COVID-19 (WHO progression scale \\\u003C5. Patients receiving oxygen therapy for reasons other than a pulmonary COVID-19 are eligible).\n3. ≥ 16 years of age (for patients recruited in Italy and in Norway, ≥ 18 years of age);\n4. Immunocompromised as defined by ≥ 1 risk factors for severe COVID-19 as assessed by the FOPH list (criteria 5: diseases\u002Ftreatments leading to immune suppression) or other immunosuppression criteria such as Severe immunosuppression (e.g., HIV infection with CD4 + T cell count \\\u003C350 \u002F µl) Neutropenia (\\\u003C1000 neutrophils \u002F µl) ≥1 week Lymphocytopenia (\\\u003C200 lymphocytes\u002Fµl) On dialysis treatment Hereditary immunodeficiencies Intake of drugs which suppress the immune system (e.g. glucocorticoids for a long time \\[an equivalent dose of prednisone \\>20 mg\u002Fday \\> 3 months\\], monoclonal antibodies, cytostatics, biological products, everolimus, mTOR inhibitors etc.) in the last 12 months Active cancer under cytostatics or targeted therapy known to be immunosuppressive (e.g., platinum salts, cyclophosphamide, anthracyclines, taxanes, 5-fluorouracil, gemcitabine, purine inhibitors, proteasome inhibitors) or associated with hematologic toxicity (neutropenia, lymphopenia), for example sunitinib, imatinib, regorafenib. Aggressive lymphomas (all types) Acute lymphatic leukemia Acute myeloid leukemia Acute promyelocytic leukemia T prolymphocytic leukemia Primary central nervous system lymphoma Stem cell transplantation Light chain amyloidosis Chronic lymphoid leukemia Multiple myeloma Sickle cell disease Bone marrow transplant Organ transplant Being on the waiting list for an organ transplant\n5. Willing and able to comply with study requirements and restrictions as described in the informed consent form (ICF)\n6. Enrolled in or a beneficiary of a Social Security program (State Medical Aid (AME) is not a Social Security program) or holders of health insurance (LAF for participants recruited in Norway).\n7. Participant's or its legal representative's signature of the informed consent form\n\nExclusion Criteria:\n\n1. SARS-CoV-2 PCR ≥30 CT at screening\n2. Hypersensitivity to study drugs (active substance(s) or excipients)\n3. Body weight \\\u003C 40 kg\n4. AST and\u002For ALT \\> 5 times the upper limit\n5. Cirrhosis Child-Pugh score C\n6. Is taking or is anticipated to require any prohibited therapies\\*.\n7. Participation in another interventional clinical study with an investigational compound or device, including COVID-19 therapeutics, where the study intervention is performed in the 28 days preceding the inclusion and the 10 days after the inclusion. Investigators of the different clinical studies should agree on participant's inclusion.\n8. Presence of any condition for which, in the opinion of the investigator, participation would not be in participant's best interest or that could prevent, limit, or confound the protocol-specified assessments\n9. Having received antiviral treatments against SARS-CoV-2 in the 14 days before the inclusion with exception of those having received one or two doses of nirmatrevir\u002Fr in the 24h preceding the inclusion in the study.\n10. Pregnant or breastfeeding female\n\n    * Study SOPs based on recommendations from the Liverpool COVID-19 interactions, French Society for Pharmacology and Therapeutics (https:\u002F\u002Fsfpt-fr.org\u002Frecommandations-et-publications) and French Speaking Transplantation Society will be provided to guide investigators.",{"count":237,"type":22},256,[239],"PHASE2","The overall purpose of the trial is to evaluate the efficacy and safety of possible combination antiviral therapy DAA (remdesivir + nirmatrelvir\u002Fr)∞ versus the reference monotherapy (nirmatrelvir\u002Fr alone) and to assess the efficacy and safety of increasing the nirmatrelvir\u002Fr course from 5- to 10 days in immunocompromised patients diagnosed with asymptomatic or mild to moderate COVID-19.",[242,243],"COVID-19","Immunodeficiency","2026-02-19",{"date":246,"type":33},"2026-02-23",{"date":248,"type":33},"2023-04-27",{"date":250,"type":22},"2027-06-30",{"name":39,"class":40},18,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":263,"conditions":264,"keywords":269,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":41},"100624695","pregnancy-and-viral-infections-impact-on-pregnant-women-and-their-children-french-prospective-cohort-100624695","NCT07412977","\"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort\"","\"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort.\"","VIROPREG","Inclusion Criteria:\n\nPregnant women :\n\n* Cis-gender pregnant woman wishing to carry her pregnancy to term and give birth in one of the maternity units participating in the research, whatever the term of pregnancy (inclusion as soon as possible after conception, whatever the outcome);\n* Age ≥18 years;\n* Viral infection studied known before pregnancy or diagnosed during pregnancy;\n* Signed, free, informed and written consent;\n* Be cared for in one of the maternity units taking part in the study\n\nNewborns\u002Fchildren:\n\n\\- Free, informed, written and signed consent of parental guardians.\n\nExclusion Criteria:\n\nPregnant women :\n\n* Planned delivery in a non-study center;\n* Planned absence that could hinder participation in the research;\n* Vulnerable population (minors, persons under guardianship or trusteeship, or persons deprived of their liberty by judicial or administrative decision);\n* Level of French oral comprehension insufficient according to the investigator for the research process understanding\n\nNewborns\u002Fchildren:\n\n* Refusal of parental authority to allow newborn\u002Fchild to participate in study\n* Follow-up of the child planned in a center not participating in the study\n* Scheduled absence of parents that could hinder the child's participation in the study;",{"count":262,"type":22},5160,"The VIROPREG study is a French prospective multicenter cohort study that aims to assess the impact of viral infections and antiviral treatments received during pregnancy on maternal and child health. The study focuses on both chronic viral infections: human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)\\] and on arbovirus infections.\n\nThis study aims at investigating the following research questions:\n\n* What is the rate of mother-to-child transmission for each virus?\n* What are the effects of maternal infection on (i) pregnancy outcomes, (ii) the mother's physical and psychological health, and (iii) the fetus' health and development, with a focus on long-term psychomotor development in children born to women living with HIV?\n* What is the impact of antiretroviral and\u002For antiviral prophylactic and\u002For therapeutic treatments administered during pregnancy on maternal and fetal health? Mother-child pairs will be followed from pregnancy through delivery and from birth until the child reaches 7 years of age. Each mother-child pair will be enrolled into one of four cohort groups based on the maternal infection.\n\nHIV Cohort:\n\nPregnant women living with HIV who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6-8 weeks post-partum)\n* Participate in additional follow-up by phone call or videoconference at 4- and 7-years post-partum for research purposes\n* Complete questionnaires at inclusion, delivery, 4- and 7- years postpartum\n* In case of breastfeeding, receive follow-up care aligned with routine schedules for up to 2 years postpartum, including 2 additional visits specifically for research at 2- and 3- months postpartum.\n* In selected cases: provide blood, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes (pharmacological and virological analyses).\n\nChildren born to mothers living with HIV and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age\n* Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.\n\nHBV Cohort:\n\nPregnant HBV-infected women who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6- 8 weeks post-partum)\n* Complete questionnaires at inclusion and delivery\n* Provide blood samples during follow-up visits for research purposes.\n\nChildren born to HBV-infected mothers and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth to 2 years of age\n* Participate in additional follow-up for research purposes at 3 months and 18-24 months of age.\n\nHCV Cohort:\n\nPregnant HCV-infected women who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6 - 8 weeks post-partum)\n* Complete questionnaires at inclusion and delivery\n* Provide blood samples during follow-up visits for research purposes.\n\nChildren born to HCV-infected mothers and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age\n* Attend additional follow-up visits scheduled at 3 and 9 months of age for research purposes.\n\nArbovirus Cohort:\n\nPregnant women infected with arbovirus who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to delivery\n* Participate in additional follow-up for research purposes at 4 years after delivery.\n* In case of breastfeeding, women will be monitored for research purposes at Day 7 and Day 30 postpartum\n* Complete questionnaires at inclusion, Day 7-10 from the inclusion, delivery and 4 years after delivery\n* Provide blood, amniotic fluid, placenta, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes.\n\nChildren born to mothers infected with arbovirus and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age.\n* Participate in additional follow-up for research purposes at inclusion, Day 7 and Day 30 after inclusion\n* Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.",[219,265,266,267,268],"HBV Infection","HDV Infection","HCV Infection","Arbovirus Infections",[270,271,272,273,274,275,276,277,278,279,280,281],"Pregnancy","HIV","HBV","HCV","Arbovirus","National health data system","Neurocognitive disorders","Quality of life","Pregnancy viral infections","Mother-to-child transmission","Social epidemiology","Hepatitis","2026-02-09",{"date":284,"type":33},"2026-02-17",{"date":286,"type":22},"2026-02",{"date":288,"type":22},"2039-12",{"name":39,"class":40},{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":50,"minAge":4,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":316},"100580769","phase-3-ebola-post-exposure-prophylaxis-100580769","NCT06841614","EBOla Post-Exposure Prophylaxis","Evaluation of the Efficacy of a Post-exposure Prophylaxis (PEP) Strategy in Contacts at High Risk of Developing Ebola Virus Disease (EVD)","EBO-PEP","Inclusion criteria\n\n* Last high-risk contact within the last 5 days\n* No sign or symptoms of EVD\n* Signed and dated informed consent from participants over the age of majority to participate in the trial or from a representative of parental authority for minor participants.\n\nNon-inclusion criteria\n\n* History of vaccination with Ervebo or any other EVD vaccine within the last 5 years (self-reported by the participant)\n* History of confirmed EVD within the last 5 years (self-reported by the participant)\n* Hypersensitivity to any of the experimental medical products (IMP) or their excipients (self-reported by the participant)\n* Participation in another therapeutic or vaccine trial for EVD\n* Any other reason that, at the investigator's discretion, could compromise the participant's safety and cooperation in the trial.",{"count":299,"type":22},160,[55],"EBO-PEP is a multicentre, multi-epidemic, phase III, comparative, controlled, randomised, strict superiority trial in two unblinded parallel arms.\n\nThe trial will be open during EVD epidemics and will recruit asymptomatic participants at high risk of developing EVD.\n\nParticipants will be randomized (1:1) into one of two trial arms:\n\n* Arm 1 (ERV): Ervebo D0 (72 million PFU IM)\n* Arm 2 (ERV+IMZ): Ervebo D0 (72 million PFU IM) + Inmazeb IV (150 mg\u002Fkg) D0 + Ervebo D56 (revaccination)\n\nDefinition of high-risk:\n\nDirect contact with a person with EBOV PCR-confirmed EVD with diarrhea, vomiting or external bleeding (\"wet symptoms\"), or with their body fluids; Direct contact with the dead body of a person with confirmed or probable EVD; Needlestick with a syringe contaminated by the blood of a person with confirmed or probable EVD; Or a child born to or breastfed by an individual with EVD\n\nTrial follow-up All participants are monitored daily for a minimum of 21 days.\n\nSome visits are conducted in person at the investigation site, also called the Post-Exposure Prophylaxis (PEP) center:\n\n* at Day 5, Day 10, and Day 21 for the ERV arm,\n* at Day 5, Day 10, Day 21, and Day 56 for the ERV+IMZ arm. Other visits are conducted at home or by phone, in collaboration with the Ministry of Health's surveillance team.\n\nParticipants in the ERV+IMZ arm have an in-person visit at Day 56 to be revaccinated with the Ervebo vaccine to compensate for potential inhibition of the vaccine response when Ervebo is administered simultaneously with Inmazeb.\n\nParticipants in the ERV arm have a phone visit at Day 56. For all participants, a phone visit is scheduled at Day 60. It corresponds to the last visit for all trial participants.\n\nFollow-up in Case of Hospitalisation In case of clinical signs suggestive of EVD, participants enter the suspected case management pathway at the Ebola Treatment Center (ETC).\n\nIf EVD is confirmed by EBOV PCR, participants are allowed at the ETC, and their study samples are discontinued. They continue to be followed by the research team, and daily data are collected throughout their stay at the ETC until they are discharged alive or deceased. The day of discharge from the ETC marks the end of follow-up in the study for these participants.\n\nOf note, participants in the ERV+IMZ arm who have confirmed EVD are not revaccinated at day 56.\n\nOf note, participants in the ERV+IMZ arm who have confirmed EVD are not revaccinated at day 56.\n\nIf EVD is not confirmed, participants continue to be followed up by the PEP center according to the protocol.",[303],"Ebola Virus Disease",[303,305,306,307],"EBOV","High-Risk contact","Post-Exposure Prophylaxis","2026-01-21",{"date":310,"type":33},"2026-01-22",{"date":312,"type":22},"2026-09",{"date":314,"type":22},"2028-08-01",{"name":39,"class":40},4,{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":82,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":4},"100454803","phase-2-impact-of-delay-between-administration-of-inmazeb-administration-and-vaccination-by-ervebo-on-vaccine-immune-response-on-healthy-volunteers-100454803","NCT05202288","Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers","Phase IIa, Randomized, Open-label, Parallel-group Trial to Assess the Immunogenicity, Safety and Tolerability of Ervebo Vaccine Administered With Inmazeb to Healthy Adult Volunteers.","Inclusion Criteria:\n\n* Available for the duration of the protocol follow-up;\n* Consent to participate ;\n* Agreed not to participate in another clinical research study until the end of the trial follow-up.\n\nExclusion Criteria:\n\n* Prior history of EVD (self-reported);\n* Previous vaccination with r-VSV-ZEBOV or any other Ebola vaccine (self-reported);\n* Previous administration of Ebola antibody;\n* HIV-1 and\u002For 2 positive serology;\n* Pregnant women (positive pregnancy test);\n* Breastfeeding women;\n* To the opinion of the investigator, any clinically significant acute\u002Fchronic condition that would limit the participant\\'s ability to meet the requirements of the study protocol;\n* Taking Immunosuppressive therapy;\n* Participation in another clinical research study within the last 30 days;\n* Allergy to any component of the vaccine or Mabs;\n* Person deprived of freedom by a judicial or administrative decision;\n* Any other reason that, at the investigator\\'s discretion, would compromise the participant\\'s safety and cooperation in the trial.",{"count":325,"type":22},132,[239],"Ebola virus disease (EVD) is emerging regularly in various African countries for various reasons: during contact with mortal remains, during an unsafe burial or following the viral dissemination around a recovered patient.\n\nHowever, tools to fight the spread of the disease are being made available to countries affected by EVD. A vaccine (Ervebo), developed by the Merck laboratory, demonstrated its efficacy in protecting contacts and contacts of contacts in the \"Ebola That's Enough\" trial and two monoclonal antibodies (Mabs) have demonstrated their efficacy in reducing mortality in patients with EVD: REGN-E3B (Inmazeb) and Mab114 (Ebanga).\n\nThe question of their use in post-exposure prophylaxis (PEP), defined as the treatment of contacts at very high risk of contracting EVD, is essential. Vaccination with Ervebo does not appear to be a good standalone option for PEP, particularly because antibody synthesis is delayed, and the vaccine is likely to be inactive for 10 days after administration. Monoclonal antibodies, on the other hand, seem to be a promising avenue in this indication because of their rapid action on the inhibition of virus entry into the cell.\n\nMoreover, Ervebo vaccine expresses the viral target recognized by mAbs, GP EBOV. It is therefore possible that the vaccine response (production of vaccine antibodies) is inhibited by mAbs, which bind to GP EBOV and prevent vaccine replication, particularly in the case of concomitant administration.\n\nHowever, no data on vaccine efficacy in combination are available. The question of the interaction between the monoclonal antibody and Ervebo and the delay between the administration of these two strategies remains unresolved.\n\nThe hypothesis of this trial is that Ervebo vaccine efficacy is diminished with the concomitant administration of a monoclonal antibody, especially if this administration is close (short time between Mabs and vaccination). We hypothesize that with an optimal delay between Mabs and vaccination, the immunogenicity of the vaccine when administered with monoclonal antibodies could be non-inferior to the vaccine alone, thus providing optimal short and long term protection.\n\nThe main objective of this study is to evaluate the extent of effect, if any, of Inmazeb administration on vaccine-induced neutralizing antibody responses to Zaire Ebola virus by Ervebo vaccine. If an interaction is observed, this will possibly enable determination of the time interval required between the administration of Inmazeb and Ervebo vaccine.\n\nThe trial will have 6 arms. A control arm of vaccination alone will serve to characterize the immune response to the vaccine and it will be used as a comparator of vaccine immune response in the intervention arms. A control arm of mAb alone will serve to characterize the pharmacokinetic profile of mAb in the Guinean population. The 4 arms including different doses of Inmazeb plus vaccination were designed to mimic a time interval between Ervebo and Inmazeb administration (15, 57 and 169 days after Inmazeb).",[303],[330,331],"Post Exposure Prophylaxis","Ebola vaccine",{"date":310,"type":33},{"date":334,"type":22},"2027-01",{"date":336,"type":22},"2027-08",{"name":39,"class":40},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":82,"sex":50,"minAge":344,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":347,"conditions":348,"keywords":350,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":361},"100620268","frailty-geriatric-syndromes-and-care-pathways-of-older-adults-living-with-hiv-in-west-africa-100620268","NCT07355413","Frailty, Geriatric Syndromes and Care Pathways of Older Adults Living With HIV in West Africa","Inclusion Criteria:\n\n* HIV+ Group\n\n  * Person 60 years of age and older\n  * Infected with HIV-1 and\u002For 2\n  * Able to move around the data collection site\n  * Having given free and informed consent\n* HIV- Group\n\n  * Person 60 years of age and older\n  * HIV-uninfected\n  * Able to move around the data collection site\n  * Having given free and informed consent\n\nExclusion Criteria:\n\nPerson deprived of liberty (guardianship, curatorship, judicial safeguard) Karnofsky Index 50≤50% Hospitalized\n\n\\-","60 Years",{"count":346,"type":22},600,"With currently available antiretroviral therapy, people living with HIV (PLWHIV) are living longer. This exposure to HIV and combination antiretroviral therapy may accelerate the aging of this population, thus increasing the prevalence of premature frailty.\n\nThere are few data on the prevalence of frailty and geriatric syndromes among older people living with HIV (OpHIV) in sub-Saharan Africa (SSA) and the screening and diagnostic tools to identify them.\n\nThe initiation contract financed by the ANRS-MIE in 2021 whose objective was to 1) carry out an inventory and evaluate the feasibility of a project for monitoring OpHIV in Burkina-Faso in Côte d'Ivoire and Togo and 2) to select the collection tools adapted to the description of geriatric syndromes in these elderly people has allowed to highlight the following (i) The collection of data on geriatric conditions and syndromes is almost non-existent in the daily care and management practice (ii) there is a significant proportion (10,6%) of PLWHIV aged 60 years and over in the active files of the PLWHIV care centers that participated in the survey (iii) Adapted screening tools have been selected and will allow documentation of the above-mentioned syndromes. This research project, which follows on from this initiation contract, will therefore make it possible to obtain data from the geriatric evaluation, to identify the specificities of PLWHIV by comparing them to a population not infected with HIV and to propose geriatric management adapted to PLWHIV. Its innovative nature also lies in its mixed approach combining quantitative and qualitative methods, which will make it possible to document the needs and resources for the care of PLWHIV in a global and holistic manner.\n\n600 participants, aged 60 years and over (300 living with HIV and 300 not living with HIV), in three West African countries (Burkina Faso, Côte d'Ivoire, Togo) will be included in this study whose primary objective is to compare the prevalence of frailty among people aged 60 years and over (PA60) between HIV-infected and non-HIV-infected; the secondary objective is to estimate the prevalence of frailty among PA60 according to HIV status. A population-based matching will be performed on sex and age class (threshold 70 years), during the recruitment of HIV- PA60.\n\nThis will be a mixed study combining:\n\n* A \"clinical\" component comprising a stratified, comparative, international, multicenter cross-sectional study;\n* A \"health systems strengthening\" component combining a quantitative cross-sectional survey and a qualitative survey;\n* A qualitative socio-anthropological component including individual interviews and focus groups with people living with HIV60, their families and caregivers.\n\nThe 3 components will be conducted with a time lag between the different components due to the overlapping constitution of the source populations.\n\nMost research on aging with HIV in the context of SSA has been very clinically focused (e.g., frailty or cognitive impairment). This research will provide a more comprehensive approach that takes into account the different levels of factors influencing health (individual, health system, social environment).",[349],"Older Adults",[271,351,352,353],"Frailty","Geriatric syndromes","Care pathways","2026-01-14",{"date":308,"type":33},{"date":357,"type":22},"2026-03",{"date":359,"type":22},"2029-03",{"name":39,"class":40},6,{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":389},"100531694","phase-3-doravirine-versus-dolutegravir-based-antiretroviral-regimens-in-treatment-nave-people-living-with-hiv-1-infection-100531694","NCT06203132","DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection","Phase III, Open-label, Randomized, Multicenter Trial EvaLuating the Non-inferiority of DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection","ELDORADO","Inclusion Criteria:\n\n* Be at least 18 years of age on the day of signing the informed consent.\n* Be HIV-1 positive as determined according to national testing strategies\n* Have a plasma HIV-1 RNA ≥1000 copies\u002FmL within 30 days prior to the randomization,\n* Have HIV treatment indication based on physician assessment according to local treatment guidelines\n* Be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents\n* For women or transgender men of childbearing potential i.e. of childbearing age who are not menopausal, or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or not refraining from sexual activity: negative urinary test for pregnancy and acceptance to use contraceptive methods\n* Understand the study procedures and voluntarily agree to participate by giving written informed consent for the trial.\n\nNon-inclusion Criteria:\n\n* Has ongoing (pulmonary or extra-pulmonary) tuberculosis\n* Has any other history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.\n* Is infected with HIV-2 or co-infected with HIV-1 and HIV-2\n* Has received cabotegravir long acting or dapivirine pre-exposure prophylaxis (PrEP).\n* Has received oral pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) in the past three months or has had no negative HIV-1 serology performed\n* Has documented or known resistance or possible resistance to study drugs (in France and where national guidelines recommend screening for primary resistance before starting first-line ART) as defined by the ANRS MIE AC43 Resistance group\n* Has the following laboratory values at screening visit, within 30 days prior to the randomization:\n\n  * AST (SGOT) and ALT (SGPT) \\>4.0 x upper limit of normal\n  * Estimated glomerular filtration rate at time of screening \\\u003C60 mL\u002Fmin\u002F1.73m², based on the CKD-EPI equation\n* Has participated in a study with an investigational compound\u002Fdevice within 30 days prior to signing informed consent or anticipates participating in such a study involving an investigational compound\u002Fdevice during the course of this study.\n* Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study\n* Requires or is anticipated to require any of the prohibited or contraindicated medications noted in the trial protocol.\n* Has significant hypersensitivity or other contraindication to any of the components of the study drugs.\n* Is pregnant, breastfeeding, or expecting to conceive at any time during the study.\n* Has any condition which might, in the investigator's opinion, compromise the safety of treatment and\u002For patient's adherence to study procedure.\n* Is a person under guardianship or deprived of freedom by a judicial or administrative decision",{"count":371,"type":22},610,[55],"Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.",[375],"HIV-1-infection",[94,377,378,379,380],"ART-naïve","doravirine","dolutegravir","non-inferiority","2026-01-06",{"date":383,"type":33},"2026-01-07",{"date":385,"type":33},"2025-01-27",{"date":387,"type":22},"2027-11",{"name":39,"class":40},19,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":82,"sex":50,"minAge":83,"maxAge":344,"enrollmentInfo":398,"targetDuration":4,"studyType":23,"phases":400,"briefSummary":402,"conditions":403,"keywords":405,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":417},"100579194","phase-1-study-comparing-safety-and-immunogenicity-of-intranasal-covid-19-vaccine-and-mrna-booster-in-healthy-adults-100579194","NCT06821126","Study Comparing Safety and Immunogenicity of Intranasal COVID-19 Vaccine and mRNA Booster in Healthy Adults","Randomized, Controlled, Multicenter Phase I\u002FII Study Comparing the Safety and Immunogenicity of a Booster Dose of an Intranasal COVID-19 Vaccine Expressing SARS-CoV-2 N\u002FS Recombinant Proteins With a Booster Dose of COVID-19 mRNA Vaccine in Healthy Adults (MUCOBOOST)","MUCOBOOST","Inclusion Criteria:\n\n1. Written informed consent obtained from the participant.\n2. Be male or female between the ages of:\n\n   1. ≥ 18 and ≤ 55 years for phase I\n   2. ≥ 18 and ≤ 60 years for phase II.\n3. Good general health as determined at the discretion of the investigator (vital signs, medical history, and physical examination).\n4. BMI: 18,5 kg\u002Fm² ≤ BMI ˂30 kg\u002Fm².\n5. Received at least 3 doses of a COVID-19 mRNA vaccine, last booster dose received at least 6 months prior to trial vaccine administration OR 2 doses of a COVID-19 mRNA vaccine and confirmed SARS-CoV-2 infection at least 6 months prior to inclusion in the trial.\n6. Has expressed interest and availability to meet the trial requirements.\n7. For a woman of childbearing potential, plan to be non-pregnant AND use of highly effective contraception from screening until the end of the trial.\n8. Agree to abstain from donating blood\u002Fplasma or any other bodily fluids from the time of vaccination until 1 year after vaccination (only for LVT-001 vaccine).\n9. Agree to stay in the geographical area of one of the clinical sites for the duration of the trial.\n10. Agree to implement barrier measures as much as possible (washing hands and wearing a mask) against COVID-19 and respiratory infections between D0 and D28.\n11. Agree to be registered in the computerized file of the Ministry of Health (VRB).\n12. Be affiliated to French social security system.\n\nExclusion Criteria:\n\n1. Temperature ≥ 38.0°C or symptoms of acute self-limiting illness such as upper respiratory tract infection or gastroenteritis within three days prior to vaccine dose.\n2. Any form of contraindication to the trial vaccines tested.\n3. History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might alter nasal mucosa and affect vaccine response.\n4. A piercing or obstruction in the nostrils that could impede vaccine administration.\n5. Previous nasal surgery or nasal cauterization.\n6. History of frequent epistaxis.\n7. Virologically documented (PCR or antigenic test) history of COVID-19 in the past 6 months.\n8. Positive COVID-19 PCR test at screening visit.\n9. Medical problems due to alcohol.\n10. Illicit drug use within the past 12 months.\n11. Participation in another trial within 60 days prior to the enrolment visit or planned participation during the present trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.\n\n    Note: Participation in an observational study is allowed.\n12. Received influenza vaccination within 14 days prior to trial vaccination, or any other licensed vaccine within 4 weeks prior to study vaccination.\n13. Vaccination with a COVID-19 vaccine other than mRNA vaccine.\n14. Known sensitivity to any of the ingredients of the trial vaccines.\n15. Known allergic reaction to plastic.\n16. Positive serology for hepatitis B (HBsAg), C (anti-HCV antibodies) and HIV 1-2.\n17. History of severe adverse events following vaccine administration including anaphylactic reaction and associated symptoms such as rash, breathing problems, angioedema, and abdominal pain, or a history of allergic reaction that could be triggered by a component of the SARS-CoV-2 vaccine at the time of the first vaccine administration.\n18. Pregnancy positive test (βHCG test) or pregnancy or breastfeeding.\n19. Received immunoglobulin or other blood products within three months prior to inclusion or planned administration before the trial completion.\n20. Received an immunosuppressive therapy for underlying disease or a treatment with immunosuppressive or cytotoxic drugs or a cancer chemotherapy or radiation therapy within the previous 36 months.\n21. Received drugs such as corticosteroids at a dosage \\> 10 mg prednisone equivalent\u002Fday or inhalers corticosteroids, within 3 months prior to inclusion (excluding corticosteroid topical preparations for cutaneous application).\n22. Abnormal and deemed clinically significant result by the investigator following the routine analyzes carried out at the time of the screening visit (any grade 4 biological result, even if deemed not clinically significant by the investigator, constitutes an exclusion criterion).\n23. History of severe psychiatric disorders that may affect participation in the trial.\n24. Any other serious chronic illness requiring immediate monitoring by a hospital specialist.\n25. Any other condition that, in the opinion of the investigator, would compromise the safety or rights of a volunteer participating in the trial or render the subject unable to comply with the protocol.\n26. Phase II only: Participants included in phase I will not be included in phase II.\n27. Participants under legal protection (e.g., guardianship, tutorship).",{"count":399,"type":22},238,[401,239],"PHASE1","This Phase I\u002FII trial in France evaluates safety and immunogenicity of a booster dose of an intranasal COVID-19 vaccine (LVT-001) versus a booster dose of a COVID-19 mRNA vaccine (Pfizer-BioNTech) in healthy adult volunteers.\n\nAs a first-in-human trial, Phase I will assess the safety and immunogenicity of three escalating doses of the LVT-001 vaccine across 3 cohorts of 12 volunteers per dose level.\n\nBased on cumulative data collected up to Day 28 visit from the last included participant in the Phase I, the go\u002Fno-go decision for Phase II and selection of the optimal dose will be performed.\n\nPhase II will then evaluate the immunogenicity of the selected intranasal dose of LVT-001 vaccine, compared to the standard of care of intramuscular COVID-19 mRNA Pfizer-BioNTech booster.",[404],"Healthy",[242,404,406,407,408],"Nasal","vaccine","intranasal","2025-12-10",{"date":411,"type":33},"2025-12-18",{"date":413,"type":33},"2025-05-09",{"date":415,"type":22},"2028-03",{"name":39,"class":40},5,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":23,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":177},"100484623","phase-2-tnf-inhibitors-to-reduce-mortality-in-hiv-1-infected-patients-with-tuberculosis-meningitis-100484623","NCT05590455","Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis","ANRS 12404 TIMPANI: Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis: a Phase II, Multicenter, Randomized Clinical Trial","TIMPANI","Inclusion Criteria:\n\n* Age ≥18 years\n* HIV-1 infection\n* Definite or probable tuberculosis meningitis\n* Standard tuberculosis meningitis treatment ≤3 days: anti TB drugs at standard doses and high-dose dexamethasone as per WHO guidelines\n* Signed informed consent form by patient or relative.\n\nExclusion Criteria:\n\n* Other concomitant neurological infection, i.e. toxoplasmosis, cryptococcosis, progressive multifocal leukoencephalopathy, bacterial meningitis, neuro-syphilis\n* Asymptomatic positive cryptococcal antigen in serum\n* HBsAg positive or anti hepatitis C virus antibodies positive\n* Alanine transaminase (ALT)\\>5 ULN\n* Rifampicin-resistant TB detected by GeneXpert MTB\u002FRIF Ultra\n* History of previous TB treatment in patients with GeneXpert MTB\u002FRIF Ultra negative or unavailable\n* Current use of drugs contraindicated with study drugs and that cannot be safely stopped\n* Allergy to study drugs or any of their components\n* Uncontrolled opportunistic infection\n* Moderate to severe cardiac insufficiency (NYHA classes III \u002F IV)\n* Any condition which might, in the investigator's opinion, compromise the safety of treatment and\u002For patient's adherence to study procedures\n* For women of childbearing age: 1) Pregnancy or breastfeeding; 2) Refusal to use effective contraception to be discussed with the investigator\n* Subjects participating in another clinical trial evaluating therapies and including an exclusion period that is still in force during the screening phase\n* Person under guardianship, or deprived of freedom by a judicial or administrative decision",{"count":427,"type":22},130,[239],"Randomized phase II clinical trial which aims to assess the impact on 3-month mortality and safety of adding adalimumab to standard treatment (anti-tuberculosis drugs and corticosteroids) in HIV patients with tuberculosis meningitis in 3 countries (Brazil, Mozambique, and Zambia).",[58,431],"HIV I Infection","2025-12-08",{"date":434,"type":33},"2025-12-15",{"date":436,"type":33},"2023-04-11",{"date":438,"type":22},"2027-12",{"name":39,"class":40},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":82,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":454,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":177},"100556219","identification-of-molecular-signatures-of-high-risk-oncogenic-hpv-and-study-of-their-associations-with-the-presence-of-high-grade-lesions-andor-anal-cancer-10-years-after-inclusion-in-the-anrs-ipergay-trial-100556219","NCT06522256","Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of High-grade Lesions and\u002For Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial","HPVsign","Inclusion Criteria:\n\n* Participant in the ANRS IPERGAY clinical trial who was included in the initial HPV sub-study;\n* Informed and written signed consent\n* Participant with regular health insurance\n\nExclusion Criteria:\n\n* Participant under guardianship or curatorship\n* Participant with free State medical assistance\n* Participant who disagrees with the use of data collected as part of their participation in the ANRS IPERGAY trial.",{"count":448,"type":22},100,[87],"HPVsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the HPV substudy of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high-grade lesions and\u002For anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and\u002For diagnosed since the end of participation in the ANRS IPERGAY trial.",[452,453],"HPV Infection","Anal Cancer",[455],"HSIL","2025-11-27",{"date":458,"type":33},"2025-12-04",{"date":460,"type":33},"2025-03-20",{"date":462,"type":22},"2027-07-30",{"name":39,"class":40},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":82,"sex":50,"minAge":471,"maxAge":472,"enrollmentInfo":473,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":475,"conditions":476,"keywords":478,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":4},"100567949","diagnostics-and-surveillance-of-acute-meningo-encephalitis-among-children-in-cambodia-with-a-focus-on-japanese-encephalitis-virus-100567949","NCT06674837","Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus","DEMELE-JEV","Inclusion Criteria:\n\nCohort 1\n\n* All children aged between 2 and 14 years.\n* No fever or history of fever in the past 14 days.\n* Consenting to return to the hospital for follow-up visits.\n* Consenting to blood sampling.\n* Written informed assent\u002Fconsent to participate in the study.\n\nCohort 2\n\n* Hospitalized patients aged between 2 and 14 years.\n* Any neurological disorder.\n* Any fever within the past 72 hours.\n* Written informed assent\u002Fconsent to participate in the study.\n* No contraindication for lumbar puncture (LP).","2 Years","14 Years",{"count":474,"type":22},4000,"The primary objective of this study is to quantify the clinical burden of Japanese Encephalitis (JE) and the asymptomatic circulation of JEV among Cambodian children, through two pediatric cohorts: non-febrile children at recruitment and children hospitalized with febrile neurological syndrome (FNS). Secondary objectives include estimating anti-JEV seropositivity rates, identifying individual risk factors and living conditions associated with JEV infection, characterizing clinical and biological profiles related to disease severity, and evaluating the role of deficiencies in interferon (IFN) response in severe JEV infections.",[477],"Japanese Encephalitis",[479,480],"Japanese encephalitis","arbovirus","2025-09-10",{"date":483,"type":33},"2025-09-11",{"date":485,"type":22},"2025-10-15",{"date":487,"type":22},"2028-01",{"name":39,"class":40},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":496,"targetDuration":498,"studyType":122,"phases":4,"briefSummary":499,"conditions":500,"keywords":504,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":4},"100604208","study-of-the-prevalence-of-transmitted-hiv-1-resistance-viral-diversity-and-cluster-identification-in-patients-at-the-time-of-hiv-1-diagnosis-100604208","NCT07146529","Study of the Prevalence of Transmitted HIV-1 Resistance, Viral Diversity, and Cluster Identification in Patients at the Time of HIV-1 Diagnosis","PRINAVIH","Inclusion Criteria:\n\n* Participant (male or female) aged 18 years or older ;\n* Participant newly diagnosed in the laboratory, for whom mandatory HIV seropositivity reporting to Santé Publique France (SPF) is required ;\n* Participant naïve to all antiretroviral treatments (except PrEP and\u002For post-exposure prophylaxis \\[PEP\\]) ;\n* Participant with an available HIV resistance genotype, including amplification of at least reverse transcriptase and protease ;\n* Participant who has not objected to participating in the study.\n\nExclusion Criteria:\n\n* Participant who objects to the use of their data ;\n* Participant currently on antiretroviral treatment ;\n* Participant subject to legal protection measures (safeguard of justice).",{"count":497,"type":22},30060,"1 Day","The primary objective of the study is to determine the frequency of transmission of viruses carrying at least one antiretroviral resistance mutation in all participants newly diagnosed with HIV-1",[501,502,503],"HIV Seropositivity","HIV Drug Resistance","HIV Infections",[505,94,506,507,508,509,510],"Genotyping","HIV drug resistance","Transmitted resistance","Viral diversity","Transmission clusters","Primary infection","2025-08-21",{"date":513,"type":33},"2025-08-28",{"date":515,"type":22},"2025-09",{"date":517,"type":22},"2036-09",{"name":39,"class":40},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":523,"acronym":524,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":50,"minAge":526,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":529,"briefSummary":530,"conditions":531,"keywords":533,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":4},"100600514","phase-4-access-to-hepatitis-c-treatment-in-cameroon-comparison-of-a-simplified-test-and-treat-strategy-to-a-standard-strategy-100600514","NCT07098481","Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy","ACCESS+","Inclusion Criteria:\n\n* Persons of both genders aged 21 years or older\n* Anti-HCV positive;\n* Living in the study area\n* Agreeing to participate in the trial and signing the informed consent form.\n\nExclusion Criteria:\n\n* Participationin a previous study on HCV treatment\n* Previous sofosbuvir treatment\n* HBsAg positive or indeterminate;\n* Pregnancy test positive ;\n* Life-threatening condition ;\n* Impairment of the person making it difficult, if not impossible, for them to participate in the trial or to understand the information given to them.","21 Years",{"count":528,"type":22},576,[25],"Hepatitis C is a common and potentially serious disease. However, there are treatments that can cure it. That's why it's so important to detect the hepatitis C virus (HCV) and treat those affected. Today, many hepatitis C sufferers in Cameroon (and elsewhere) remain untreated.\n\nThe aim of this research is therefore to evaluate a simplified screening and treatment strategy (developed specifically for the Cameroonian context) in comparison with a standard strategy (based on usual care), in order to improve access to hepatitis C treatment in Cameroon. If the results of this research are positive, this strategy could be recommended to health authorities in Cameroon and other comparable countries.",[532],"Hepatitis C Virus Infection",[534,535],"simplified test and treat strategy","hepatitis C","2025-07-31",{"date":538,"type":33},"2025-08-01",{"date":540,"type":22},"2025-09-01",{"date":542,"type":22},"2028-06-30",{"name":39,"class":40},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":157,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":4},"100599228","phase-2-immunotherapy-with-baricitinib-and-sirolimus-alone-and-in-combination-for-the-control-of-hiv-1-replication-after-antiretroviral-treatment-interruption-100599228","NCT07081763","Immunotherapy With Baricitinib and Sirolimus, Alone and in Combination, for the Control of HIV-1 Replication After Antiretroviral Treatment Interruption","Immunotherapy With a JAK1\u002FJAK2 Inhibitor (Baricitinib) and an mTORC1 Inhibitor (Sirolimus), Alone and in Combination, for the Control of HIV-1 Replication After Antiretroviral Treatment Interruption: a Phase II Multicenter, Multi-arm, Multi-stage, Randomized, Double-blind, Placebo-controlled, Adaptative Trial","Inclusion Criteria:\n\n* Age ≤ 18 years and ≥ 65 years,\n* Weight ≥ 50 kg and ≤ 100 kg,\n* HIV-1 infection having been diagnosed at primary infection stage with an HIV-1 RNA VL \\> 1,000 copies\u002FmL and either a negative or incomplete WB \\[0-5\\] bands or IB \\[0-3\\] bands and\u002For a previous negative HIV-1 ELISA within the past 3 months,\n* Having initiated ART within 2 months of primary HIV-1 infection diagnosis,\n* Having received ART continuously without interruption,\n* Receiving ART for at least 1 year prior to enrollment,\n* Receiving DTG-, BIC-, RAL-, or RPV-based ART (PI-, EVG\u002Fc-, NVP-, EFV-, ETR- or DOR-based ART must have been switched to DTG-, BIC-, RAL-, or RPV-based ART at W-8).\n* Sustained HIV-1 plasma viral load ≤ 50 copies\u002FmL for ≥ 6 months prior to enrollment (with at least two measurements, including the screening value),\n* Blood CD4 T-cell count ≥ 500 cells\u002FµL (on the last two measurements, including screening),\n* Willing to interrupt ART for ATI and change ART regimen before if required to avoid drug-drug interactions,\n* Willing to take valaciclovir 500 mg QD from W0 to W10 to prevent recurrence of herpes or herpes zoster,\n* If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (condoms or PrEP for their sexual partners).\n* If able to have children, willing to use a highly effective method of contraception (combined oral contraceptive pill; implanted contraceptive device, IUD\u002FIUS; physiological or anatomical sterility for self of partner); willing to undergo blood bHCG at screening and before ATI.\n* Willing to comply with visit schedule and provide blood samples according to the protocol.\n* Written informed consent (at the latest on the day of the enrollment visit and before any exams to be performed in the context of the trial) (article L1122-1-1 of the French CSP).\n* Participant covered by Health Insurance (article L1121-11 of the French CSP).\n\nExclusion Criteria:\n\n* HIV-2 infection,\n* Previous interruption of ART,\n* Loss of virologic suppression (VL \\> 200 c\u002FmL) at any time while on effective ART; previous blips of VL between 50 and 200 c\u002FmL allowed, except in the 6 months prior to screening,\n* Long-acting ART based on CAB\u002FRPV, lenacapavir, islatravir, or ibalizumab,\n* Receiving PI-, EVG\u002Fc-, NVP-, EFV-, ETR- or DOR-based ART beyond W-8,\n* No other active ARV regimen in addition to the current one,\n* Pregnant or lactating woman,\n* Woman expecting to conceive during the trial period,\n* Any medical condition that will contraindicate an interruption of ARV treatment,\n* History of coronary artery disease, stroke, or blood clots; thrombophilia,\n* High cardiovascular risk (SCORE2 ≥ 7.5% if \\\u003C 50 years, or ≥ 10% if 50-65 years),\n* Active cancer or history of cancer,\n* Active opportunistic infection,\n* Active or latent tuberculosis (unless prophylaxis has been received in the past); participant must be screened for latent tuberculosis according to routine practice prior to initiation of immunotherapeutic interventions,\n* Chronic hepatitis B (positive HBs antigen and\u002For positive HBV DNA) or past-hepatitis B infection (positive anti-HBc antibodies) or hepatitis C (positive HCV RNA); cirrhosis,\n* Treatment with systemic corticosteroids or immunosuppressants currently or within 12 weeks prior to study randomization,\n* History of experimental vaccination against HIV,\n* Ongoing treatment with strong CYP3A4 inducers or inhibitors,\n* History of hypersensitivity to macrolides.\n\nLaboratory parameters at screening:\n\n* Polynuclear neutrophils \\\u003C1 G\u002FL; Hemoglobin \\\u003C10 g\u002FdL; Platelets \\\u003C100 G\u002FL\n* GFR \\\u003C30 ml\u002Fmin\u002F1.73m2\n* TP \\\u003C50%; ALAT\u002FASAT \\>5x ULN; Bilirubin \\>3x ULN",{"count":552,"type":22},191,[239],"Natural HIV controllers (HICs) and post-treatment controllers (PTCs) are rare examples of people living with HIV (PLWH) who achieve control of HIV replication without the need for antiretroviral therapy (ART). Therapeutic strategies that can induce such a phenotype are therefore a key goal in the quest for a remission of HIV infection.\n\nJAK1\u002FJAK2 and mTORC1 are key biological pathways involved in the regulation of HIV-1 transcription and replication, as well as the functional capacities of immune effectors, primarily CD8 T cells (exhaustion status and immunometabolic properties), but also NK cells. Immunotherapeutic interventions using a JAK1\u002FJAK2 inhibitor and an mTORC1 inhibitor, alone or in combination to achieve an additive or synergistic effect, are therefore promising candidates to induce a PTC-like phenotype. The use of combined approaches of immunotherapies with different and potentially complementary effects may increase the likelihood of achieving viral control.\n\nThis study aims at evaluating the efficacy and safety of three experimental immunotherapeutic interventions (i.e., baricitinib, a JAK1\u002FJAK2 inhibitor, alone; sirolimus, an mTORC1 inhibitor, alone; or their combination) on viral control following an analytic treatment interruption (ATI) of antiretroviral drugs in PLWH who had initiated ART during primary HIV-1 infection. This randomized clinical trial will use an innovative multi-arm multi-stage adaptive design.",[375],[557],"Antiretroviral Treatment Interruption","2025-07-21",{"date":560,"type":33},"2025-07-23",{"date":562,"type":22},"2026-05",{"date":564,"type":22},"2030-11",{"name":39,"class":40},{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":573,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":576,"briefSummary":577,"conditions":578,"keywords":579,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":590,"locationsCount":4},"100597120","hbv-universal-vs-point-of-care-based-antiviral-treatment-to-prevent-mother-to-child-transmission-100597120","NCT07054359","\"HBV unIversal vs Point-Of-Care-based Antiviral treatMent to Prevent Mother-to-child Transmission\"","HIPOCAMP","Inclusion Criteria:\n\n1. ≥18 years old, or ≥ the legal age of majority as defined by each country, on the day of inclusion.\n2. Pregnancy.\n3. Intention to attend antenatal care visits in the Primary Health Center or the Rural Hospital\n4. Living in an area covered by the Primary Health Center or the Rural Hospital on the start date of the trial\n5. Positive HBsAg identified during the screening phase of the study\n6. Free, informed, and written consent, signed by the person and the investigator at the latest on the day of inclusion and before any examination carried out as part of the study.\n\nExclusion Criteria:\n\n1. HIV co-infection.\n2. HBV treatment ongoing on the day of inclusion.\n3. Having at least one of the following criteria indicatives of the third trimester of pregnancy:\n\n   * Gestational Age-Based Exclusion:\n\n   The reported gestational age is ≥28 weeks, based on the last menstrual period (LMP) if known.\n   * Ultrasound-Based Exclusion:\n\n   Fetal biometry (e.g., head circumference, femur length) on ultrasound suggests a gestational age of ≥28 weeks.\n   * Fundal Height-Based Exclusion:\n\n   Symphysis-fundal height (SFH) measurement of ≥ 28 cm which corresponds to approximately 28 weeks of gestation.\n4. Severe gravid disease at inclusion, which poses a life-threatening risk to the mother and\u002For child\n5. Any concomitant medical condition that, according to the clinical site investigator, would contraindicate participation in the study.\n6. Concurrent participation in any other study (unless approved in writing by the Global Principal Investigators).","50 Years",{"count":575,"type":22},3200,[87],"To achieve global elimination of hepatitis B virus (HBV), it is crucial to eliminate HBV mother-to-child transmission (MTCT) by ensuring high coverage of birth dose vaccine and expanding the adoption of peripartum antiviral prophylaxis (PAP) by tenofovir. Current international guidelines require hepatitis B surface antigen (HBsAg)-positive pregnant women to undergo viral load (VL) quantification to identify those at high risk (VL ≥200,000 IU\u002FmL) who should receive PAP. However, VL testing remains inaccessible in many low- and middle-income countries (LMICs), particularly in rural areas. Consequently, in the forthcoming guidelines, the WHO is going to issue a conditional recommendation for administering PAP to all HBsAg-positive women lacking access to VL testing. Although this universal strategy may appear promising for simplifying the diagnostic process, it may result in overtreating the majority of HBsAg-positive pregnant women, estimated at 85% in Africa and 70% in Asia, for whom birth dose vaccine is likely sufficient. Moreover, the real-world applicability of this strategy in LMICs has never been formally tested.\n\nAs an innovative alternative, the adoption of a rapid point-of-care test for hepatitis B core-related antigen (HBcrAg-RDT) is proposed to identify women eligible for PAP.This test requires only a drop of capillary blood, eliminating the need for electricity or centrifugation, and can provide a reliable result within 45 minutes. Compared to the universal strategy, HBcrAg-RDT strategy is expected to be less expensive and could prevent unnecessary tenofovir exposure for both women and their fetuses. Our aim is to establish the non-inferiority of the HBcrAg-RDT strategy, in comparison to the universal strategy, in terms of effectiveness, defined as the reduction in maternal VL at the time of childbirth, a main driver of the MTCT risk. This will be approached through a multidisciplinary framework integrating health economics, implementation science, and health policy analysis.",[265,270],[270,580,581,582,583],"Mother to child transmission","Public health","Hepatitis B","Cluster-randomized controlled trial","2025-06-27",{"date":586,"type":33},"2025-07-08",{"date":588,"type":22},"2025-11",{"date":487,"type":22},{"name":39,"class":40},{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":82,"sex":599,"minAge":83,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":602,"briefSummary":603,"conditions":604,"keywords":606,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":316},"100501800","phase-3-efficacy-acceptability-and-safety-of-event-driven-hiv-prep-using-tafftc-in-msm-in-thailand-and-france-100501800","NCT05813964","Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF\u002FFTC in MSM in Thailand and France.","A Randomized Controlled Trial to Evaluate the Efficacy, Acceptability and Safety of Event-driven Pre-exposure Prophylaxis for HIV Using TAF\u002FFTC in Men Who Have Sex With Men in Thailand and France","SimpPrEP","Inclusion Criteria:\n\n* Male at birth age ≥ 18 years old\n* Reporting having sex with men\n* Negative 4th generation HIV-1 and HIV-2 test\n* Reporting condomless anal sex with men not more often than two days during the previous month and able to plan their sexual activity\n* Risk of HIV acquisition based on self-report of at least one of the following behaviors during the 6 months before enrollment: condomless anal sex with at least 2 different sexual partners, sexually transmitted infection (rectal chlamydia and\u002For rectal gonorrhea and\u002For syphilis), provided or received money goods or favor in exchange of sex, binge drinking or use of non-injectable recreational drugs.\n* Consenting to participate and agreeing to follow the clinical trial procedures, including adherence to study visits every 3 months\n* In France: Person affiliated with or benefiting from a social security system (article L1121-11of the public health code in France)\n\nNon-inclusion criteria:\n\n* Symptoms and\u002For clinical signs consistent with an acute HIV infection\n* Women and trans women\n* Taking feminizing hormone therapy\n* Positive HIV test result at screening or enrollment even if HIV infection is not confirmed\n* Positive hepatitis B surface antigen test\n* ALT or AST \\> 4 ULN\n* Estimated glomerular filtration rate \\\u003C 60mL\u002Fmin\u002F1.73m²\n* History of chronic kidney disease, osteoporosis, osteopenia or pathological fracture not related to trauma\n* Hypersensitivity to the study products F\u002FTDF or F\u002FTAF\n* Past or concurrent participation in a HIV vaccine trial or concurrent participation in another clinical trial without the agreement of the principal investigators of the two trials\n* Use of intravenous drugs within the last 12 months\n* Person under legal guardianship\n* Not likely to comply with the clinical trial procedures or with any condition incompatible with study participation, upon the investigator's judgement.\n* Ongoing Post-Exposure Prophylaxis (PEP) for HIV","MALE",{"count":601,"type":22},524,[55],"The purpose of this study is to evaluate the efficacy, acceptability, and safety of a simplified event-driven pre-exposure prophylaxis of HIV based on oral TAF\u002FFTC in HIV-uninfected cisgender men who have sex with men (MSM).\n\nPrimary objective: To assess the efficacy of emtricitabine 200 mg + tenofovir alafenamide 25 mg (F\u002FTAF), taken 2 to 24 hours before sexual intercourse followed by a second dose 24 hours after the first intake, in reducing the risk of HIV acquisition in MSM relative to the background HIV incidence rate.",[605],"HIV\u002FAIDS",[607,608,609,610],"PrEP exposure prophylaxis (PrEP)","On-demand","Event-driven","TAF","2025-06-17",{"date":613,"type":33},"2025-06-20",{"date":615,"type":33},"2024-06-05",{"date":617,"type":22},"2027-05",{"name":39,"class":40},{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":82,"sex":50,"minAge":83,"maxAge":626,"enrollmentInfo":627,"targetDuration":4,"studyType":23,"phases":629,"briefSummary":630,"conditions":631,"keywords":632,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":640,"locationsCount":149},"100535730","phase-1-safety-and-immunogenicity-of-a-sub-unit-protein-cd40rbdv-bivalent-covid-19-vaccine-adjuvanted-or-not-as-a-booster-in-volunteers-100535730","NCT06255626","Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.","A Phase 1\u002F2 Multicenter, Randomized Study of the Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.","Inclusion Criteria:\n\n* Healthy volunteers Age ≥18 and \\\u003C85\n* Able to understand and comply with planned study procedures and sign an informed consent before performance of any study-related screening procedures\n* Who has received a primary series of vaccination and ≥ 1 booster(s) of COVID-19 mRNA vaccination(s) with the last boost at least 6 months prior to the inclusion in the study\n* Subjects has adequate organ functions, evidenced by normal ALT, AST, and alkaline phosphatase\n* Normal haematology lab values\n* Negative virology assessment\n* Normal Urine testing\n* Volunteers must meet the eligibility criteria in the approved package labelling of the active comparator\n* For women of childbearing potential: use of an effective contraceptive method and negative pregnancy test. For male participants, use of an effective method of contraception with their partner\n\nExclusion Criteria:\n\n* Acute febrile infection within the previous 72 hours and\u002For presenting symptoms suggestive of COVID-19 or SARS CoV 2 infection within the previous 28 days\n* Immunosuppressive medications received within last three months before first IMP administration or within 6 months for chemotherapies\n* Immunoglobulins within 90 days before first IMP administration\n* Blood products within 120 days before first IMP administration\n* Any medical condition, such as cancer, that might impair the immune response\n* Use of any experimental therapy\n* Intent to participate in another study of an investigational research agent within 4 weeks prior to the enrolment visit or until the end of the study\n* Currently pregnant or breastfeeding\n* History of severe adverse events following vaccine administration\n* Any bleeding disorder considered as a contraindication to an intramuscular injection\n* A condition that requires active medical intervention or monitoring to avert grave danger to Asthma other than mild, well-controlled asthma.\n* Hypertension\n* BMI ≥ 40 kg\u002Fm2; ≤ 18 kg\u002Fm2; or BMI ≥ 35 kg\u002Fm2 with 2 or more of the following: age \\> 45, current smoker, known hyperlipidemia, blood pressure is defined as consistently ≥ 140 mm Hg systolic and ≥ 90 mm Hg diastolic\n* Malignancy\n* Asplenia\n* Seizure disorder\n* History of hereditary angioedema acquired angioedema, or idiopathic angioedema\n* History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including arrhythmia requiring medication, treatment, or clinical follow-up\n* History of autoimmune disease\n* Any medical, occupational, or other condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence\n* Psychiatric condition that precludes compliance with the protocol.\n* Live attenuated vaccines received within 30 days before first IMP administration or scheduled within 28 days after one of the last injection according to the protocol\n* Vaccines that are not live attenuated vaccines and were received within 21 days prior to first IMP administration\n* Allergy treatment with antigen injections within 30 days before first IMP administration and until the end of the study","84 Years",{"count":628,"type":22},215,[401,239],"The goal of this clinical trial, on healthy volunteers, is to learn more about safety and reactogenicity of the CD40.RBDv vaccine.\n\nThe main questions that will be studied are :\n\n* Is the CD40.RBDv (adjuvanted or not) safe ?\n* Does the CD40.RBDv (adjuvanted or not) imply an immunologic response ? Participants will receive, depending on their randomization arm, 1 or 2 injections of the CD40.RBDv vaccine or a single injection of approved mRNA vaccine",[242],[633,242],"Vaccine","2025-04-23",{"date":636,"type":33},"2025-04-25",{"date":638,"type":33},"2024-05-27",{"date":515,"type":22},{"name":39,"class":40},{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":645,"acronym":646,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":50,"minAge":526,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":650,"conditions":651,"keywords":652,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":4},"100586329","hiv-1-non-group-m-in-cameroon--study-of-genotypic-and-phylogenetic-diversity-obsocam-100586329","NCT06913959","HIV-1 Non-group M in Cameroon : Study of Genotypic and Phylogenetic Diversity (OBSOCAM)","OBSOCAM","Inclusion Criteria:\n\n* All available samples tested positive for HIV during the national Health survey of Cameroon in 2011 And 2018\n* All Individuals who came to Centre Pasteur in Yaoundé or Garoua for HIV screening or viral load monitoring.\n\nExclusion Criteria:\n\n* Insufficient quantity or degraded Dried Blood Spot samples\n* All HIV-positive individuals aged less than 21 years, infected with a Group M HIV-1 virus, or those who refused to participate in the study",{"count":649,"type":22},220,"The aim of the study is to study the genotypic characteristics of HIV-1 non-M circulating in the whole Cameroon and their genetic evolution.",[219],[653,654],"HIV genetic diversity","HIV-1 non-M variants","2025-04-04",{"date":657,"type":33},"2025-04-08",{"date":659,"type":22},"2025-06-30",{"date":661,"type":22},"2027-07-01",{"name":39,"class":40},{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":669,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":671,"targetDuration":498,"studyType":122,"phases":4,"briefSummary":673,"conditions":674,"keywords":675,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":686,"locationsCount":4},"100580853","prevalence-of-drug-resistant-hiv-1-strains-in-patients-experiencing-virologic-failure-multivir2025-100580853","NCT06842706","Prevalence of Drug-resistant Hiv-1 Strains in Patients Experiencing Virologic Failure. (MULTIVIR2025)","Prevalence of Drug-resistant Hiv-1 Strains in Patients Experiencing Virologic Failure.(MULTIVIR2025)","MULTIVIR2025","Inclusion Criteria:\n\n* Patient (male or female) 18 years of age or older.\n* Patient who has given his or her consent to participate in the study.\n* Patient on antiretroviral therapy for at least six months, with a plasma viral load (VL) greater than 50 copies\u002FmL on at least two consecutive measurements.\n\nExclusion Criteria:\n\n* Patients opposed to the use of their data.",{"count":672,"type":22},800,"In this cross-sectional, national and multicenter study, the main objective is to determine the prevalence of multi-drug resistant viruses (i.e., viruses that are resistant or possibly resistant to at least one antiretroviral drug from four different therapeutic classes: NRTI, NNRTI, PI, INSTI) among people with HIV 1 (PWH) experiencing virological failure.",[219],[271,676,677,678,679],"drug resistance","antiretrovirals","multi-drug resistant","virological failure","2025-02-24",{"date":682,"type":33},"2025-02-26",{"date":684,"type":22},"2025-04",{"date":357,"type":22},{"name":39,"class":40},""]