[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Michael Hoelscher\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":139},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,77,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100555530","phase-1-thervacb---a-heterologous-protein-primemva-boost-therapeutic-hepatitis-b-vaccine-candidate-100555530",false,"NCT06513286","TherVacB - A Heterologous Protein Prime\u002FMVA Boost Therapeutic Hepatitis B Vaccine Candidate","TherVacB - A Multi-center Phase 1b\u002F2a Trial to Assess Safety, Tolerability and Immunogenicity of a Heterologous Protein Prime\u002FMVA Boost Therapeutic Hepatitis B Vaccine Candidate","TherVacB","Inclusion Criteria:\n\n1. Ability to understand the subject information and to personally name, sign and date the informed consent to participate in the clinical trial.\n2. Provided written informed consent.\n3. Confirmed chronic hepatitis B virus (HBV) infection (CHB) that fulfills the following criteria:\n\n   * HBsAg positive for ≥ 6 months\n   * Anti-HBs negative\n   * HBsAg levels 100-2000 IU\u002FmL\n   * HBV nucleos(t)ide analog (NUC) treatment for ≥ 6 months\n   * HBV load \\\u003C 100 IU\u002Fml at least twice within the last 6 months\n4. Males and non-pregnant, non-lactating female with negative pregnancy test aged 18-70 years at time of informed consent.\n5. Apart from CHB no other clinically significant health problems as determined during medical history and physical examination and clinical laboratory results at the screening visit. The following abnormal laboratory parameters will be permitted:\n\n   * leukocyte count ≥ 2.500\u002Fµl\n   * platelet count ≥ 150.000\u002Fµl\n   * ALT elevation ≤ 60 U\u002FL\n   * AST should be ≤ 40 U\u002FL\n   * bilirubin should be ≤ ULN\n   * INR should be ≤ ULN\n   * CrCL \\> 60mL\u002Fmin Non-clinically significant, minor deviations of laboratory measurements can be tolerated as they will not increase the risk of the individual having an adverse outcome from participating in this clinical trial as judged by the investigator.\n6. Subject may be on chronic or as needed medications if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate worsening of a pre-existing medical condition.\n7. Body mass index 18.5-32.0 kg\u002Fm2 and weight \\>50 kg at screening.\n\nExclusion Criteria:\n\n1. Known liver disease other than hepatitis B\n2. Advanced liver fibrosis or cirrhosis (demonstrated by ultrasound or transient elastography ≥8 kP in fasting condition)\n3. WOCBP who don't agree to comply with the applicable contraceptive requirements of the protocol\n4. History of hepatocellular carcinoma\n5. Coinfection with Hepatitis C Virus (HCV) (RNA positive), Human Immunodeficiency Virus (HIV) or Hepatitis Delta virus (anti-Delta positive)\n6. Regular alcohol intake \\>30 g\u002Fd (male), \\>20 g\u002Fd (female) or any other known drug addiction.\n7. Donation of blood or blood products (e.g., 450 mL or more of plasma or platelets) within 60 days prior to receiving the first dose of the investigational medicinal product (IMP).\n8. Receipt of any vaccine in the 2 weeks prior to first trial vaccination (4 weeks for live vaccines), during trial or planned receipt of any vaccine in the 3 weeks following last trial vaccination. Exception: Required recommended pandemic vaccines or emergency vaccines (e.g., tetanus) are allowed.\n9. Previous receipt of an MVA based vaccine (e.g. as part of previous MVA studies, monkeypox or smallpox vaccination)\n10. Known allergy to components of the vaccine products as referred in Table 6 (incl. hypersensitivity to yeast components, E.coli proteins or lipids, duck's or hen's egg white, penicillin, streptomycin, , kanamycin) or history of life-threatening reactions to vaccines containing one of the substances.\n11. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.\n12. Clinically relevant findings in ECG or significant thromboembolic events in medical history.\n13. Evidence for a condition in the subject's medical history or during medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of vaccine products.\n14. Administration of immunoglobulins and\u002For any blood products within the 3 months preceding the administration of the first dose of the trial vaccine.\n15. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 3 years.\n16. Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to systemic corticosteroids, biologicals and Methotrexate) within the last 3 years. Exception: topical corticosteroids, e.g. occasional asthma spays or systemic corticosteroids for medical emergencies.\n17. Any chronic or active neurologic disorder, including diagnosis of migraine, seizures and epilepsy. Exception: a febrile seizure as a child and occasional headaches.\n18. Participation in a clinical investigation within the past 4 weeks or five times the half-life of the previously taken IMP.\n19. Investigator or employee of the study site with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, natural or adopted child) of the investigator or employee with direct involvement in the proposed study.\n20. Subjects who are known or suspected\n\n    * not to comply with the clinical trial directives.\n    * not to be reliable or trustworthy.\n    * not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed.","ALL","18 Years","70 Years",{"count":21,"type":22},81,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This study is an open-label, ascending dose phase 1b\u002F2a trial to assess the safety and immunogenicity of a heterologous protein prime\u002FMVA boost therapeutic hepatitis B vaccine in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.",[29],"Chronic Hepatitis B","RECRUITING","2026-06-09",{"date":33,"type":34},"2026-06-11","ACTUAL",{"date":36,"type":34},"2025-06-12",{"date":38,"type":22},"2026-12",{"name":40,"class":41},"Michael Hoelscher","OTHER",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100501295","phase-2-panacea---step2c--01-100501295","NCT05807399","PanACEA - STEP2C -01","A Multiple-arm, Multiple-stage (MAMS), Phase 2B\u002FC, Open-label, Randomized, Controlled Platform Trial to Evaluate Experimental Arms Including Optimised Use of Existing and Introduction of Novel Anti-tuberculosis Drugs, in Adults With Newly Diagnosed, Drug-sensitive, Smear-positive Pulmonary Tuberculosis","Inclusion Criteria:\n\n1. Provide written, informed consent prior to all trial-related procedures including HIV testing.\n2. Male or female, aged between 18 and 65 years, inclusive.\n3. Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.\n4. Newly diagnosed, previously untreated, drug susceptible pulmonary TB: presence of MTB complex and rapid molecular tests result confirming susceptibility to RIF and INH such as GeneXpert and\u002For HAIN MTBDR plus. Participants who had a previous history of TB may be enrolled in this trial, if they:\n\n   * had a good treatment response in the opinion of the investigator; i.e. TB symptoms improved sufficiently or resolved suggesting a cure of the past episode; AND\n   * no persistent microbiological positivity is seen (in case microbiological results are available); AND - their treatment course was completed AND\n   * the last dose of treatment was more than 3 months ago.\n5. A chest X-ray (no older than 2 weeks) which shows abnormalities that, in the opinion of the Investigator, are consistent with TB.\n6. Sputum positive on microscopy from concentrated sputum for acid-fast bacilli (at least 1+ on the IUATLD\u002FWHO scale) AND\u002FOR positive GeneXpert MTB\u002FRIF Ultra® semi-quantitative result \"medium\" or \"high\" on at least one sputum sample.\n7. The participant understands the interaction between the study drugs and certain foods and is willing to forgo the consumption of those foods for the period of study medication.\n8. The participant is not of child-bearing potential or is willing to use effective methods of contraception when engaging in heterosexual intercourse, as defined below:\n\n   1. Non-childbearing potential:\n\n   i. Female participant\u002Fsexual partner of male participant: Bilateral oophorectomy, and\u002For hysterectomy or bilateral tubal ligation more than 12 months ago and\u002For has been postmenopausal with a history of no menses for at least 12 consecutive months and confirmed by a FSH test.\n\n   ii. Male participant\u002Fsexual partner of female participant: Vasectomised or has had a bilateral orchidectomy minimally three months prior to screening iii. Male participants having a pregnant female partner or a male sexual partner: At least one barrier method has to be used in this case.\n\n   b. Effective contraception methods: i. Female participants: Two methods, including methods that the participant's sexual partner(s) use. At least one must be a barrier method. Contraception must be practised for at least until 12 weeks after the last dose of experimental treatment. For stage 3, female participants of child-bearing potential must have used contraception if any sexual intercourse has occurred after last menses or within the last 3 weeks (whichever is later) before participation, and agree to use non-user dependent contraception: depo-provera injection\\* or an intrauterine device additional to one barrier method.\n\n   \\*Including a back-up method of contraception for at least 7 days to prevent unintended pregnancy if injection has been administered within the first 5 days of their menstrual cycle. Otherwise, a back-up barrier method of contraception is required for one month to prevent unintended pregnancy.\n\n   ii. Male participants: Two methods, including methods that the participant's female sexual partner(s) use. At least one must be a barrier method. Effective contraception must be ensured for at least 12 weeks after the last dose of experimental treatment.\n\n   Exclusion Criteria:\n\n\u003C!-- -->\n\n1. Circumstances that raise doubt about free, unconstrained consent to study participation (e.g., person in detention or person with mental disability)\n2. Poor general condition where delay in treatment cannot be tolerated or death within four months is likely.\n3. Circumstances (in the opinion of the investigator) that raise doubt about ability to complete the follow-up during the study period.\n4. The participant is pregnant or breast-feeding or planning to become pregnant in the study period.\n5. The participant is infected with HIV with a CD4 count \\\u003C220 cells\u002Fmm3. If \\>220 cells\u002Fmm3, participants will be included only if any of the following is applicable:\n\n   • The participant is antiretroviral (ARV) naïve and able to postpone commencing HIV treatment for 2 months after the trial has started and then restrict regimens to those mentioned in section on ARVs or\n\n   • The participant is ARV experienced (has been on ARV´s a minimum of 5 months), AND: ARV treatment is compliant to, or can be modified as described in the section on Antiretroviral Therapy\n6. The participant has a known intolerance to any of the study drugs or concomitant disorders or conditions for which study drugs or standard TB treatment are contraindicated.\n7. The participant has a history of, or current evidence of clinically relevant cardiovascular metabolic, gastrointestinal, neurological, hepato-biliary, renal, psychiatric or endocrine diseases, malignancy, or any other condition that will influence treatment response, study adherence or survival in the judgement of the investigator, especially:\n\n   a. Neuropathy, or significant psychiatric disorder like depression or schizophrenia; especially if treatment for those has ever been required or is anticipated to be required b. Evidence of clinically significant extra-pulmonary TB (e.g. miliary TB, TB meningitis, but not limited lymph node involvement) c. Serious lung conditions other than TB, or significant respiratory impairment in the discretion of the investigator d. Uncontrolled diabetes mellitus or diabetes mellitus receiving\u002Frequiring treatment with metformin or sulfonylureas e. Cardiovascular disease such as myocardial infarction, heart failure, coronary heart disease, arrhythmia, tachyarrhythmia, or pulmonary hypertension f. Uncontrolled arterial hypertension (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure of ≥95 mmHg on two occasions during screening. An attempt at antihypertensive treatment during the screening period is permitted).\n\n   g. Long QT syndrome or family history of long QT syndrome or family history of sudden death of unknown or cardiac-related cause h. Alcohol, regular opiate, or other drug abuse that is sufficient to significantly compromise the safety or cooperation of the participant, that includes substances prohibited by the protocol or has led to significant organ damage at the discretion of the investigator; AND\u002FOR any abuse of methamphetamine.\n\n   i. History of optic neuropathy j. Vitiligo\n8. Any of the following laboratory findings at screening:\n\n   a. Serum amino aspartate transferase (AST) and\u002For alanine aminotransferase (ALT) \\>3x the upper limit of normal (ULN), b. Serum alkaline phosphatase or y-glutamyl transferase \\> 2.5x the ULN, c. Serum total bilirubin level \\>1.5x the ULN d. Estimated creatinine clearance -eCrCl (using the CKD-EPI 2021 creatinine formula):\n\n   \\- Stage 1: Lower than 30 ml\u002Fmin)\n\n   \\- Stage 2: Lower than 30ml\u002Fmin or lower than 60 ml\u002Fmin in participants living with HIV\n\n   \\- Stage 3: Lower than 80ml\u002Fmin e. Proteins in urine dipstick \\>=2+ f. Haemoglobin level \\\u003C7.0 g\u002Fdl g. Platelet count \\\u003C50,000\u002Fmm3, h. Serum potassium below 3 mmol\u002Fl, persisting after correction.\n9. ECG findings in the screening ECG: (one or more):\n\n   1. QTcF of \\>450 milliseconds\n   2. Atrioventricular (AV) block with PR interval \\> 200 milliseconds\n   3. QRS complex \\> 120 milliseconds\n   4. Any other changes in the ECG that are clinically relevant as per discretion of the investigator\n10. Restricted medication:\n\n    1. Treatment with any other investigational drug within 2 month prior to enrolment or enrolment into other clinical (intervention) trials during participation.\n    2. Previous anti-TB treatment with drugs active against MTB within the last 3 months prior to screening.\n    3. Unable or unwilling to abide by the requirements regarding restricted medication or have taken restricted medication. Restricted medication includes the following drug classes, with relevant timing of intake, and possible exceptions. Exceptions may be permissible after discussion with the sponsor medical expert.","65 Years",{"count":52,"type":22},390,[26],"This is a phase 2B\u002FC, open label platform study that will compare the efficacy, safety of experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis.\n\nIn stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1.\n\nIn stage 2, the experimental arm 4 containing BTZ-043 will be added. The allocation ratio will be changed to co-enrol the remaining participants in arms 1- 3 simultaneously with arm 4 in a ratio of 1:1:1:2. When arms 1-2 are fully enrolled and arm 4 is not, further participants will be randomized 1:1 to control and experimental arm 4. Not all countries will participate in stage 2.\n\nIn stage 3, participants will be allocated in parallel to control arm treatment (now designated arm 7) or the experimental arms 5 and 6, favouring arm 5, 2:1:1 over arms 6 and control. This stage will start after completion of recruitment in the stages 1 and 2. Enrolment of participants into arm 5 will proceed following review of data from the ENABLE\u002FUNITE-03 (NCT06748937), non-clinical safety data and after endorsement by the DSMB. Thus, arm 5 recruitment might start after arms 6 and 7, which may require an increase in the control arm sample size to ensure controls are recruited concomitantly.",[56,57],"Pulmonary Tuberculosis","Other Specified Pulmonary Tuberculosis",[59,60,61,62,63,64,65,66,67],"Tuberculosis, Pulmonary","Tuberculosis","Antitubercular Agents","Safety","Tolerability","Pharmacokinetics (PK)","Moxifloxacin","BTZ-043","Rifampicin","2025-10-01",{"date":70,"type":34},"2025-10-07",{"date":72,"type":34},"2023-04-14",{"date":74,"type":22},"2027-12-30",{"name":40,"class":41},10,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":84,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100536644","increasing-neonatal-hiv-test-and-treat-to-maximize-the-long-term-impact-on-infant-health-and-novel-infant-antiretroviral-treatment-100536644","NCT06267508","Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment","LIFE2Scale","Inclusion Criteria:\n\n1. Voluntary and informed consent of the mother for her own study participation (if applicable);\n2. Voluntary and informed consent of the legal guardian of the child for participation of the child in the study;\n3. Mothers\u002Flegal guardians ≥18 years of age;\n4. Documented maternal HIV infection;\n5. Willingness to consent to HIV testing for the child and herself (or just her child); and\n6. Willingness to consent to active tracing including home tracing.\n\n   Exclusion Criteria:\n7. Deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her.\n8. Having delivered more than 72h (3 days) ago;\n9. Prisoners;\n10. Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion;\n11. Stillbirths;\n12. Infant requiring emergency care (e.g. immediate or rapid occurring life threatening conditions, resuscitation, prolonged obstetric related intensive care, severe jaundice) or born with severe malformation;\n13. If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g); or\n14. Unlikely to comply with protocol as judged by the principal investigator or his designate","FEMALE",{"count":86,"type":22},6000,"OBSERVATIONAL","This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system.",[90,91,92,93,94],"Vertical Human Immunodeficiency Virus Transmission","HIV Infection Pediatric","Infant Death","Infant Morbidity","Infant, Newborn, Diseases",[96,97,98,99],"Prevention of Vertical HIV Transmission (PVHT)","Infant HIV Prophylaxis","Early Infant HIV Diagnosis","Infant Antiretroviral Treatment","2024-11-14",{"date":102,"type":34},"2024-11-18",{"date":104,"type":34},"2024-04-30",{"date":106,"type":22},"2025-12",{"name":40,"class":41},2,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":120,"conditions":121,"keywords":125,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":108},"100549544","sars-cov-2-specific-antibody-responses-and-impact-for-covid-19-disease-in-ethiopia-100549544","NCT06435403","SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Ethiopia","SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Health Care Worker and Community Members From Ethiopian Related to Natural SARS CoV-2 Infection and COVID-19 Vaccination","CoVICIS","Inclusion criteria:\n\n1. Adults, 18 years of above\n2. Provision of oral as well as written informed consent\n3. Available estimation of the period or the time-point when SARS-CoV-2 infection occurred (e.g. confirmed or highly suspected COVID-19 disease, SARS-CoV-2 anti-nucleocapsid seroconversion) (only applicable for participants included in group 1 and 2).\n4. Employed\u002Fworking in hospital (medical doctors, nurses\u002Fmidwives, students, auxiliary personnel such as cleaner, runner, social worker) for HCW\n5. Willingness to provide blood samples by venipuncture for serology and immunological characterization\n6. Willingness to provide health information, report medical events and to performed SARS-CoV-2 diagnostics (swabs for PCR) in the case of suspected COVID-19 disease\n\nExclusion criteria:\n\n1. Prisoners\n2. Mentally disturbed persons\n3. Persons for whom study participation will induce an unacceptable risk or burden as judged by the investigator (e.g. seriously sick persons)",true,{"count":119,"type":22},1000,"In this study we aim to characterize SARS CoV-2 strain specific immune response (SARS-CoV-2 Spike IgG) in health care workers and general populations at the Jimma Medical Center and the St. Paul Hospital in Addis Ababa in association to clinical immune protection and Covid-19 disease. Participants, stratified by SARS-CoV-2 infection and vaccination status, will be followed at 3-month intervals for a maximum of 2 years. Prevalence, incidence, and dynamics of SARS-CoV-2 specific antibodies as well as clinical assessments especially related to COVID-19 breakthrough disease in previously exposed\u002Fvaccinated participants will be performed. From a subset of selected participant blood sample, more in depth immunological analysis will be performed that include virus culture-based neutralization assays, antibody avidity assays, SARS-CoV-2 specific antibody epitope recognition using peptide arrays, and T-cell immunity assays (IGRA).\n\nWe also plan to analyze and model cost-effectiveness considerations related to adapted COVID-19 vaccine strategies, specifically if SARS-CoV-2 the costs for routine sero-diagnosis in high SARS-CoV-2 prevalent population prior to vaccination will impact the decision to vaccinate (no vaccination for low-risk populations or reduced vaccine dosing) and is cost-efficient. The study is largely exploratory, providing deeper insights in SARS-CoV-2 specific immune responses and interaction with SARS-CoV-2 viral variants.",[122,123,124],"SARS CoV 2 Infection","COVID-19 Breakthrough","COVID-19 Recurrent",[126,127,128,129,130],"COVID-19","Seroepidemiologic Studies","Longitudinal Studies","Ethiopia \u002F epidemiology","SARS-CoV-2","2024-07-08",{"date":133,"type":34},"2024-07-09",{"date":135,"type":34},"2022-11-10",{"date":137,"type":22},"2025-02-28",{"name":40,"class":41},""]