[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malaria-plasmodium-falciparum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malaria-plasmodium-falciparum":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,77,102,124,159],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100635952","phase-2-safety-and-efficacy-of-imatinib-in-combination-with-artemether-lumefantrine-for-uncomplicated-malaria-100635952",false,"NCT07559370","Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria","Evaluating the Safety and Efficacy of Imatinib in Combination With Artemether and Lumefantrine for Treatment of Uncomplicated Malaria","Inclusion Criteria:\n\nFor Part 1 and 2 of the study design, all individuals must meet all the inclusion criteria below:\n\n* Patients diagnosed with symptomatic mild to moderate P. falciparum malaria with a parasite density of \\>= 5000 parasites\u002Fμl\n* Adult male, age 18-55 years old or adult female, age 18-55 years that are post-menopausal, or test negative on a pregnancy test and will be on active birth control through to the end of the follow up period.\n* Provision of informed consent and agrees to hospital admission for 48-72hrs\n* Good health condition other than malaria\n* The patient has not taken anti-malarial drugs in the past 4 weeks\n\nFor Part 3 of the trial, all individuals must meet all the inclusion criteria below:\n\n* Patients diagnosed with symptomatic mild to moderate P. falciparum malaria and a parasite density of \\>= 5000 parasites\u002Fμl\n* Age 12 months to below 18 years\n* Presented by parent or legally accepted representative (LAR) who has consented to the participation of the child in the trial and agrees to hospital admission for 48-72hrs.\n* Hb levels \\> 5mg\u002FdL\n* Child has not taken anti-malarial drugs in the past 6 weeks.\n\nExclusion Criteria:\n\n* Prospective study participant, LAR and\u002For impartial witness (where applicable) declines to provide informed consent.\n* Symptoms and signs of severe or complicated malaria including:\n\n  * significant confusion or impaired consciousness (including unarousable coma)\n  * multiple convulsions (more than two episodes within 24 hours),\n  * respiratory distress\n  * circulatory collapse (systolic blood pressure \\\u003C80mm Hg with evidence of impaired perfusion)\n  * clinical jaundice plus evidence of other vital organ dysfunction\n  * simultaneous infection of unrelated origin\n* Parasite density \\> 200,000 parasites \u002Fμl\n* In the case of female participants: currently pregnant or lactating\n* Other neurological or psychiatric symptoms or disorders\n* Abnormal bleeding\n* Resting heart rate lower than 55 or higher than 100 bpm\n* History of cardiac disease\n* Signs, symptoms and laboratory results of impairment of vital organs such as liver, lungs, kidney and cardiovascular system\n* Abnormal blood chemistry:\n\n  * hemoglobin \\\u003C 9.0 g\u002FdL in adults or \\\u003C 5.0 g\u002FdL in children 12 months-18 years\n  * WBC not in the range of 4800-10,000\u002Fmm3\n  * RBC if \\\u003C 4.0x106\u002F mm3\n  * Platelet \\\u003C 1.3x105\u002F mm3\n  * ALAT not in the normal range (4 to 36 U \u002F l)\n  * ASAT not in the normal range (8 to 33 U \u002F l)\n  * Total bilirubin 0.1 to 1.2 mg \u002F 100 ml\n  * Serum protein if \\\u003C 5.5 g\u002FdL\n* Symptoms and signs of infection such as pneumonia, dengue fever, and other viral or bacterial infection.\n* Patients with symptoms of gastrointestinal infections or any sign of malabsorption that may interfere with drug absorption.\n* Concomitant infection by plasmodium species other than P. falciparum\n* Inability to attend\u002Fmeet study staff on follow up visits\n* Concomitant use of medicines, including:\n\n  * medicines used to treat high cholesterol (such as atorvastatin, lovastatin, simvastatin);\n  * medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);\n  * medicine used to treat HIV (antiretroviral medicines) including protease inhibitors (such as amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine);\n  * medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);\n  * medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem;\n  * medicines used to prevent\u002Ftreat epileptic seizures including barbiturates (such as phenobarbital), carbamazepine or phenytoin;\n  * medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin, tacrolimus);\n  * nefazodone (used to treat depression);\n  * aprepitant (used to treat nausea);","ALL","1 Year","55 Years",{"count":20,"type":21},1116,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is investigating an innovative approach to treating uncomplicated malaria by adding a drug called Imatinib to the current standard of care, Artemether + Lumefantrine (AL). The researchers hope this combination, known as ALIM, will clear infections faster and stop the spread of drug-resistant parasites that are becoming a major threat in Africa",[27],"Malaria (Plasmodium Falciparum)",[29,30,31,32,33],"Uncomplicated malaria","Artemether-lumefantrine (AL) combination therapy","Imatinib mesylate","Drug-resistant malaria","Parasite egress blockade","RECRUITING","2026-06-24",{"date":37,"type":38},"2026-06-29","ACTUAL",{"date":40,"type":38},"2026-01-20",{"date":42,"type":21},"2027-06-30",{"name":44,"class":45},"Victoria Biomedical Research Institute","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":46},"100644937","phase-2-pfspz-larc2-in-women-of-child-bearing-potential-wocbp-100644937","NCT07675785","PfSPZ-LARC2 in Women of Child-bearing Potential (WOCBP)","Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety, Immunogenicity, & Protective Efficacy of Late Liver Stage-arresting, Replication-competent Plasmodium Falciparum Sporozoite Vaccine (Sanaria® PfSPZ-LARC2 Vaccine) in Healthy African Adult Women of Childbearing Potential in Mali","Inclusion Criteria:\n\n1. Females of childbearing potential aged ≥ 18 and ≤ 38 years\n2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process\n3. In good general health and without clinically significant medical history\n4. Willing to have blood samples stored for future research\n5. Available for the duration of the study\n6. Must be willing to use reliable contraception (defined as: pharmacologic contraceptives \\[parental delivery\\] or pre-existing intrauterine or implantable device) from 21 days prior to first vaccination (study day 1) to 28 days after last vaccination (study day 57)\n7. Willingness to undergo HIV testing\n8. Report being interested in becoming pregnant within the next 1 year\n\nExclusion Criteria:\n\n1. Pregnancy at the time of enrollment\u002Fvaccination, as determined by a positive urine or serum human chorionic gonadotropin (β-hCG) test\n2. Biologically unable to become pregnant secondary to: surgical sterilization, premature ovarian insufficiency (defined as no menses for ≥12 months without an alternative medical cause)\n3. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol\n4. Hemoglobin (Hgb), WBC, absolute neutrophils, and platelets outside the local laboratorydefined limits of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically significant' abnormal values)\n5. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically significant' abnormal values)\n6. Infected with human immunodeficiency virus (HIV)\n7. Known or documented sickle cell disease by history (Note: known sickle cell trait is NOT exclusionary)\n8. Clinically significant abnormal electrocardiogram (ECG) such as abnormal QTc.\n9. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and\u002For laboratory studies including urinalysis\n10. History of receiving any investigational product within the past 30 days\n11. Participation or planned participation in a clinical trial with an investigational product prior to completion of the follow-up visit 28 days following last vaccination OR planned participation in an investigational vaccine study until the last required protocol visit\n12. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months\n13. History of a severe allergic reaction (Grade 2 or higher or per PI discretion) or anaphylaxis\n14. Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that has required the use of oral or parenteral corticosteroids at any time during the past two years)\n15. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia\n16. Known immunodeficiency syndrome\n17. Known seizure disorder or history of seizures (exclusion: simple febrile seizure during childhood) or history of migraine headaches\n18. Laboratory evidence of hepatitis B or C\n19. Known asplenia or functional asplenia\n20. Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone ≥20 mg\u002Fday) or immunosuppressive drugs within 30 days of vaccination\n21. Receipt of a live vaccine within the past four weeks or a killed vaccine within the past two weeks prior to Vaccination #1 and every subsequent vaccination day\n22. Receipt of immunoglobulins and\u002For blood products within the past six months\n23. Previous receipt of an investigational malaria vaccine in the last ten years\n24. Known allergies or other contraindications against use of artemether\u002Flumefantrine\n25. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the participant unable to comply with the protocol",true,"FEMALE","18 Years","38 Years",{"count":59,"type":21},300,[24],"A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity, and protective efficacy of 1, 6, 29-day PfSPZ-LARC2 Vaccine regimen given at a dose of 2 x10\\^5 PfSPZ or placebo in healthy WOCBP, who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future.\n\nParticipants will be randomized into two arms. Arm 1: (n= 150) will receive 3 doses of PfSPZ-LARC2 Vaccine (2x10\\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 6, 29 days.\n\nArm 2: (n= 150) will receive 3 doses of normal saline (placebo) injection via DVI at 1, 6, 29 days.\n\nAll volunteers will receive antimalarial treatment with artemether\u002Flumefantrine (AL) \\~2 to 4 weeks prior to 1st (study day -14 to -28) and \\~2 weeks prior to 3rd injection (study day 44). Participants will be monitored for safety, tolerability, immunogenicity, and malaria infection during the follow-up period. Participants will also be monitored closely for pregnancy as well post 3rd injection through the entire planned study duration (2 years post dose 1). If pregnant, women will be followed during the course of their pregnancy and for at least 1 year post-delivery (as well as their offspring) for safety and malaria infection. Malaria infections in participants and their offspring will be classified as asymptomatic or symptomatic (clinical cases).",[27],[64,65],"PfSPZ-LARC2 Vaccine","malaria","NOT_YET_RECRUITING","2026-06-23",{"date":69,"type":38},"2026-06-30",{"date":71,"type":21},"2026-07-15",{"date":73,"type":21},"2030-04",{"name":75,"class":76},"Sanaria Inc.","INDUSTRY",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":54,"sex":16,"minAge":56,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":46},"100622566","phase-2-field-trial-of-pfspz-larc2-vaccine-in-burkinabe-adults-100622566","NCT07385287","Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults","Randomized, Double-Blind, Placebo-Controlled Trial to Assess Safety, Immunogenicity, and Protective Efficacy Against Naturally Transmitted Plasmodium Falciparum Malaria of One and Two Dose Regimens of a Late Liver Stage-arresting, Replication-competent Plasmodium Falciparum Sporozoite Vaccine (Sanaria® PfSPZ-LARC2 Vaccine) in Healthy Malaria-Exposed Adults in Burkina Faso","BFSPZL2","Inclusion Criteria:\n\n1. Healthy males and females, based on clinical and laboratory findings\n2. From the age 18 to 50 years\n3. Adults with a Body Mass Index (BMI) 18 to 30 Kg\u002Fm2.\n4. Residence in the study area for the duration of the study.\n5. Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study.\n6. Willingness to be attended to by a study clinician and take all necessary medications prescribed during study period.\n7. Agreement to provide contact information of a third party household member or close friend to study team.\n8. Agreement not to participate in another clinical trial during the study period.\n9. Agreement not to donate blood during the study period (until final clearance is completed)\n10. Able and willing to complete the study visit schedule over the study follow up period.\n11. Willingness to undergo HIV, hepatitis B (HBV), hepatitis C (HCV), and sickle cell anemia tests.\n12. Volunteer participant can demonstrate their understanding of the study by responding correctly to 18 out of 20 true\u002Ffalse statements (in a maximum of two repeat attempts for those who failed to pass in the first attempt).\n13. Signed written informed consent, in accordance with local practice.\n14. Has not been treated with any antimalarial medication for at least two weeks prior to the initial clearance treatment.\n15. Female volunteers aged 18 years and above must be non-pregnant (as demonstrated by a negative urine pregnancy test), and provide consent \u002F assent of their willingness to take protocol-defined measures not to become pregnant during pre-treatment and immunization period and until 28 days after the second immunization. Acceptable measures to not become pregnant include oral or implanted contraceptives, IUD, abstinence, sterilization or sterile sexual partner. Women with a history of surgical or chemical sterilization (e.g., tubal ligation, hysterectomy, other) must provide written documentation of the procedure from a health care provider.\n16. Demonstration of the ability to complete pre-vaccination drug clearance without significant untoward effects.\n\nExclusion Criteria:\n\n1. Unable to provide informed consent including inability to pass the test of understanding.\n2. Receipt of a malaria vaccine in a prior clinical trial.\n3. History of a splenectomy or sickle cell disease.\n4. History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache.\n5. Current use of systemic immunosuppressant pharmacotherapy.\n6. Receipt of a live vaccine within 4 weeks of first immunization or of 3 or more non-live vaccines within 2 weeks of first immunization.\n7. Women who are breast-feeding, pregnant or planning to become pregnant during the study period.\n8. Known allergy to artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DHA-P), or any component of the investigational products.\n9. History of anaphylaxis or other life-threatening reaction to a vaccine.\n10. Participation in any study involving investigational vaccine or drug within 4 weeks prior to enrollment that in the estimation of the site PI might adversely affect the individual's safety or the quality of data to be collected.\n11. Evidence of increased cardiovascular disease risk; defined as \\>10% five-year risk by non-laboratory method (Gaziano, 2008).\n12. Plan to participate in another investigational vaccine\u002Fdrug research during the study.\n13. Plan for major surgery between enrollment until last study visit.\n14. Use or planned use of any drug with anti-malarial activity that is not specified by the protocol.\n15. Anticipated use of medications known to cause drug interactions with DHA-P (antiarrhythmics, neuroleptics, macrolide antibiotics, fluoroquinolones, imidazole and triazole antifungal agents, quinine, halofantrine, pentamidine and saquinavir, certain non-sedating antihistamines, all of which can affect QT intervals ) or AL (the same list of drugs affecting QT intervals plus rifampin, carbamazepine, phenytoin, St. John's wort and antiretroviral drugs).\n16. Positive HIV, HBsAg or HCV serology.\n17. History of or evidence for other chronic disease conditions including cancer, diabetes, renal failure, hypertension, tuberculosis, etc.\n18. History of arrythmias or cardiac disease, or an abnormal electrocardiogram, defined as one showing prolonged QT interval, pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions, but excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block; or other clinically significant abnormalities on the electrocardiogram.\n19. Any clinically significant deviation from the normal range in biochemistry or hematology tests measured at screening and not resolving (grade 1 abnormalities are allowed).\n20. Any medical, psychiatric, social, behavioral or occupational condition or situation (including active alcohol or drug abuse affecting social function) that, in the judgment of the site PI, impairs the participant's ability to give informed consent, increases the risk to the participant of participation in the study, affects the ability of the participant to participate fully in the study, or might negatively impact the quality, consistency, integrity or interpretation of data derived from their participation in the study.\n21. Inability to complete a course of malaria treatment prior to receipt of investigational product.","50 Years",{"count":87,"type":21},180,[24],"This is a phase 2 clinical trial of a Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) vaccine (Sanaria® PfSPZ-LARC2 Vaccine) that will assess field efficacy in Africa.\n\nThe PfSPZ comprising PfSPZ-LARC2 Vaccine contain a double deletion of the genes encoding the Mei2 and LINUP proteins, both of which are required for transition from liver to blood stage malaria. As a result, mei2-\u002Flinup- parasites undergo developmental arrest in the late liver stages without releasing merozoites into the blood stream. No blood stage parasites are produced, either asexual or sexual, and the parasite life cycle does not progress. Because Pf parasites with the LARC phenotype replicate in the liver before disintegrating, they amplify and diversify parasite protein expression and are expected to be a potent immunogen to induce anti-malarial immunity, equaling or exceeding the potency and efficacy of the replication-competent chemo-attenuated Sanaria® PfSPZ-CVac (chloroquine) vaccine approach. Because the parasites are intrinsically attenuated, they are expected to be safe and well tolerated, similar to radiation-attenuated Sanaria® PfSPZ Vaccine, to the replication deficient, early arresting PfSPZ-GA1 Vaccine, and to the single-gene(mei2)-deleted GA2 (LARC1) parasites tested at the Leiden University Medical Center that provided 90% protection against CHMI after a single dose.\n\nThe active treatments to be assessed for efficacy are one immunization of 6.0x10\\^5 PfSPZ or two immunizations with 4.0x10\\^5 PfSPZ of PfSPZ-LARC2 Vaccine four weeks apart, timed so that the immunization of the one dose regimen coincides with the second immunization of the two dose regimen.\n\nThe alternative treatment is immunization with normal saline (placebo group), which is indistinguishable from the test article.\n\nThe primary variable of interest is whether and when trial participants develop Pf malaria parasitemia during surveillance. Malaria parasitemia will be detected by thick blood smear (TBS), which will be performed every two weeks starting two weeks after the second vaccination (to allow time for the vaccine to work) and extending to week 26 after the second vaccination (24-week surveillance period). Surveillance will continue for 40 weeks but the primary outcome will be determined at 24 weeks of surveillance so the data are comparable to other studies of PfSPZ vaccines.",[27],[65,92,93,64],"Plasmodium falciparum","PfSPZ Vaccine","2026-05-28",{"date":96,"type":38},"2026-06-01",{"date":98,"type":38},"2026-05-04",{"date":100,"type":21},"2027-04",{"name":75,"class":76},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":54,"sex":16,"minAge":56,"maxAge":85,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":46},"100635856","phase-1-malaria-cvd-36000-gates-inv090205-100635856","NCT07558122","Malaria CVD 36000; Gates INV090205","Phase I, Double-blind, Randomized Study of Physiological Parameters Biosensor Detection Device(s) Diagnosis of P. Falciparum NF54 Strain Malaria Following Controlled Human Malaria Infection and Post-hoc Analysis of Wearable Biosensor Device Detection","Inclusion Criteria:\n\n1. Male or non-pregnant, non-breastfeeding female between 18 and 50 years of age (inclusive) at the time of consent.\n2. Participants must be able to provide written informed consent.\n3. Participants must be healthy as established by medical history and clinical examination at study entry.\n4. Participants must pass a comprehension (defined as 80%) test and be able to comply with all study requirements.\n5. Both males and females are eligible to participate as per the following:\n\nParticipants physically capable of pregnancy must agree to use effective contraception to avoid pregnancy from 28 days before enrollment through 10 months after last administration of investigational product are eligible to participate. An effective contraceptive method is defined as one that results in a failure rate of less than 1% per year when it is used consistently and correctly. Adequate contraceptive precautions include intrauterine contraceptive device, oral contraceptives, diaphragm, or condom in combination with contraceptive jelly, cream, or foam; Norplant® or Depo-Provera®, through the completion of study visits to minimize any potential risk.\n\ni. Effective contraception does not apply to participants of child-bearing potential with same sex partners, when this is their preferred and usual lifestyle.\n\nii. Adequate contraception does not apply to women with documented surgical sterility (tubal ligation, bilateral oophorectomy, salpingectomy, or hysterectomy), congenital sterility, who have a diagnosis of infertility and are not undergoing treatment, or women who have not had a menstrual period in at least 1 year\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding\n2. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)\n3. History of malaria infection, or history \\> 6 months spent in a malaria endemic region within 5 years prior to enrollment.\n4. Participant seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV).\n\n   Note: Prior participants of HIV vaccine studies may result in a false positive HIV antibody test, as such, in this scenario, participant will be eligible if they have a negative HIV RNA PCR at screening.\n5. Safety laboratory test results within range at screening (as per FDA Toxicity Grading Scale, see Appendix A):\n\n   * White Blood Cell (WBC) 3,500-12,000\u002Fmm3\n   * WBC differential either within institutional normal range or accompanied by the PI or designee approval\n   * Platelets = 125,000 - 500,000\u002Fmm3\n   * Hemoglobin within institutional normal range or accompanied by the PI or designee approval\n   * Creatinine ≤ 1.1 x upper limit of normal (ULN)\n   * ALT ≤1.25 x ULN\n   * Grade 1 subclinical abnormalities in other chemistries will not lead to exclusion if the investigator considers them not clinically significant\n6. A 5-year cardiovascular risk of \\>10% using the Gaziano nomogram (Appendix B)\n7. Significant screening physical examination abnormalities at the discretion of the investigator, including a BMI \\> 35 kg\u002Fm2\n8. Electrocardiogram (ECG) with clinically significant abnormalities (examples may include: pathologic Q waves, significant ST-T wave changes, left ventricular hypertrophy, any non-sinus rhythm excluding isolated premature atrial contractions, right or left bundle branch block, advanced A-V heart block). ECG abnormalities determined by an investigator to be clinically insignificant as related to trial participation do not preclude trial enrollment. Consultation may be sought by a cardiologist at investigator discretion.\n9. Known intolerance to atovaquone or proguanil, and either artemether\u002Flumefantrine or chloroquine phosphate\n10. Routine use of antibiotics, or use of antibiotics with known antimalarial effect (azithromycin, trimethoprim\u002Fsulfamethoxazole or tetracyclines) within 4 weeks prior to CHMI.\n11. Anticipated use of medications known to cause drug reactions with chloroquine or atovaquone-proguanil (Malarone®) such as cimetidine, metoclopramide, antacids, and kaolin.\n12. Administration of immunoglobulins and\u002For any blood products during the period starting 90 days preceding the CHMI or planned administration during the study period\n13. Planned administration or administration of a live vaccine\u002Fproduct not planned in the study protocol during the period starting 30 days prior to the CHMI until the study completion (routine vaccinations will be allowed if it is not administered within 14 days preceding or 21 days following CHMI)\n14. Use of any investigational or non-registered product (drug or vaccine during the period starting 30 days preceding the CHMI and\u002For planned use during the study period\n15. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90days prior to the CHMI (for corticosteroids, this will mean prednisone \\>5mg\u002Fday or equivalent; inhaled, intranasal and topical steroids are allowed)\n16. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device)\n17. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or blood draws\n18. History of a splenectomy, sickle cell disease or sickle cell trait\n19. History of skeeter syndrome or anaphylactic response to mosquito-bites\n20. Autoimmune disease or history of autoimmune disease\n21. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study product or related to a study procedure\n22. Major congenital defects or serious chronic illness\n23. Presence of any implanted device which could bias biosensor data (e.g., pacemaker, etc.)\n24. Acute disease and\u002For fever (≥37.5°C\u002F99.5°F oral body temperature) at the time of enrollment: note that a participant with a minor illness such as mild diarrhea, mild upper respiratory infection, etc., without fever, may be enrolled at the discretion of the investigator\n25. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, neurological disorders, seizures or renal functional abnormality, as determined by history, physical examination or laboratory screening tests\n26. History of bipolar disorder, schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the participant from participating in the study\n27. Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the Investigator, will make it unlikely that the participant will comply with the protocol.\n28. Any other condition which, in the opinion of the investigator, prevents the participant from participating in the study",{"count":110,"type":21},32,[112],"PHASE1","In order to control infections, the investigators must first detect them. Biosensor devices may allow early detection and intervention for infectious diseases, helping the investigators to recognize infections early, and allow for early treatment. This will lower transmission of infections and lower costs for treating someone who becomes ill. This is a study testing whether a wearable device such as a wristband and\u002For earphones can measure early biologic signals to detect identify infection in prior to seeing symptoms related of a disease. As a first test of this technology, the investigators will expose participants to injectable malaria or placebo. This is called a \"Controlled Human Malaria Infection\" (CHMI). Everyone who takes part in the CHMI may get malaria infection. The investigators will detect malaria using standard blood tests. The investigators will also look for early symptoms of malaria infection like changes in temperature, heart rate, breathing, sleep patterns, and changes in skin and muscle activity or voice. These signals may allow the investigators to detect early malaria infection. This is a study testing whether a wearable device such as a wristband and\u002For earphones can measure early biologic signals to detect malaria infection before symptoms occur, as confirmed by standard blood testing.",[27],"2026-04-22",{"date":117,"type":38},"2026-04-30",{"date":119,"type":21},"2026-06-13",{"date":121,"type":21},"2026-08",{"name":123,"class":45},"University of Maryland, Baltimore",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":54,"sex":16,"minAge":131,"maxAge":85,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":143,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":46},"100635079","phase-1-safety-and-pk-of-mmv371-lai-in-healthy-adults-and-adolescents-in-rwanda-100635079","NCT07548021","Safety and PK of MMV371 LAI in Healthy Adults and Adolescents in Rwanda","A Randomized, Double-Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 Long-Acting Injection in Healthy Adults and Adolescents in Rwanda","Inclusion Criteria:\n\n1. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For adolescents, written assent and parental\u002Flegal authorized representative (LAR) consent must be obtained, in accordance with local regulations.\n2. Able to provide proof of identity to the satisfaction of the Investigator or delegate completing the enrolment process\n3. Able and willing to communicate effectively and comply with all study procedures for the duration of the study (including IM injections, safety assessments, blood sampling, malaria monitoring, follow-up visits)\n4. Living within local jurisdiction of trial site(s) and available for the duration of the trial Demographics and Contraception\n5. Male or female participants aged 12 to 50 years inclusive at the time of signing informed consent\u002Fassent.\n6. WOCBP must be non-pregnant and non-lactating, confirmed by a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test at admission, prior to IMP administration. WOCBP must agree to use, at minimum, acceptable contraception methods, as defined by the Clinical Trials Coordination Group (CTCG) guidance, from 21 days prior to study Day 1 through the End-of Study visit (Week 24) (Clinical Trials Coordination Group (CTCG), 2024).\n7. Post-menopausal participants must have menopause confirmed at screening, defined as a follicle-stimulating hormone (FSH) level ≥ 25.8 mIU\u002FmL Baseline Characteristics\n8. Healthy volunteers, as determined by:\n\n   physical examination Vital signs 12 lead ECG absence of malaria symptoms at baseline (note: a positive blood smear without malaria symptoms at baseline is not exclusionary) Hematology, biochemistry or urinalysis results at screening or at the admission visit (Day -1) that are within the standard clinically acceptable laboratory ranges defined for this study (See section 10.7 Appendix 7)\n9. For adults (18-50 years): Body Weight ≥45 kg at screening\n10. For adolescents (12-17 years): body weight ≥35 kg at screening Participant-reported outcomes (PROs)\n11. Able to understand and complete participant-reported outcome assessments (e.g., injection-site reaction diary and injection acceptability assessments), either independently or with assistance, in a language and format approved by the Ethics Committee.\n\nExclusion Criteria:\n\n* Medical Conditions\n\n  1. Positive malaria blood smear microscopy at the Admission visit (Day -1).\n  2. Acute febrile illness within 96 hours prior to enrolment or within 96h prior to Day 1.\n  3. Serious adverse reaction or clinically significant hypersensitivity to drugs or formulation excipients used in the study: artemether-lumefantrine (Coartem® or generic formulations) and atovaquone (Wellvone®\u002FMepron® and\u002For Malarone® or their generics).\n  4. Any history of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis prior to enrolment that, in the opinion of the Investigator, has a reasonable risk of recurrence during the trial.\n  5. Any current uncontrolled medical or psychiatric condition, or substance abuse problems that, in the opinion of the Investigator, would make it unlikely for the participant to comply with the protocol, may interfere with study assessments, or could jeopardize the safety of the participant.\n  6. Evidence of clinically significant neurologic, cardiac, gastro-intestinal, dermatologic, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, haematological, oncologic, or renal disease, as determined by medical history, physical examination, and\u002For laboratory evaluations, including urinalysis.\n  7. History of a bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or a history of significant bruising with blood draws.\n  8. Known or documented sickle cell disease by history. Note: known sickle cell trait is not exclusionary.\n  9. Presence of sinus node dysfunction; clinically significant PR interval prolongation (\\>220 msec); intermittent second- or third-degree atrioventricular block; complete bundle branch block; sustained cardiac arrhythmias including, but not limited to, atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia except isolated extrasystoles; abnormal T wave morphology that may interfere with QT\u002FQTc assessment; or QTcF \\>450 msec (adults and adolescents).\n\n     Physical Examination\n  10. Participants who do not have adequate venous access for multiple venipunctures or cannulation, as assessed by the Investigator or delegate at screening.\n  11. Participants with tattoos, scars or other clinically significant dermatological lesions or conditions overlying the deltoid, gluteal, or vastus lateralis region that, in the opinion of the Investigator, may interfere with injection site assessments.\n\n      Diagnostic Assessments\n  12. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab). or human immunodeficiency virus (HIV) 1 and 2 antibody results.\n\n      Prior Study Participation\n  13. Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1, or within fewer than 5 elimination half-lives prior to Day 1 (whichever is longer). Note: Past, current, or planned participation in non-interventional (observational) studies is not exclusionary.\n  14. Participants who are currently enrolled in another interventional clinical trial within 90 days prior to Day 1, or who intend to participate in another interventional clinical trial during their participation in this study.\n  15. Donation of blood or plasma, or loss of more than 400 mL of blood, within 90 days prior to Day 1.\n\n      Prior and Concomitant Medication or Vaccine\n  16. Use of antimalarial chemoprevention or treatment, and\u002For antibiotics with known antimalarial activity (see Section 10.6 Appendix 6), within 6 weeks or fewer than 5 elimination half-lives prior to Screening (whichever is longer).\n  17. Current or recent (within 30 days prior to Day 1) use of rifampin\u002Frifampicin, rifabutin, tetracycline, or indinavir due to potential drug-drug interaction risk with atovaquone.\n  18. Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \\>10 mg\u002Fday) or other immunosuppressive drugs within 30 days prior to Day 1.\n  19. Receipt of a live attenuated vaccine within 4 weeks or an inactivated vaccine within 2 weeks prior to Day 1.\n  20. Receipt or planned receipt during the study of any doses of a malaria vaccine (investigational or registered, such as RTS, S\u002FAS01 or R21\u002FMatrix-M) or monoclonal antibodies (mAb) directed against Plasmodium falciparum.\n  21. Receipt of immunoglobulins and\u002For blood products within the past 6 months. Lifestyle Characteristics\n  22. History or medical, occupational, or family problems related to alcohol or illicit drug use within the past 12 months that, in the opinion of the Investigator, may interfere with study participation, compliance, or participant safety.\n\n      Other Exclusion Criteria\n  23. Participants who are, or are immediate family members of, study site staff or Sponsor employees involved in the conduct of the study.\n  24. Any other condition or circumstance that, in the opinion of the Investigator, would make the participant unsuitable for the study or could compromise participant safety or data integrity.","12 Years",{"count":133,"type":21},80,[112],"This Phase 1b study will assess the safety, tolerability and pharmacokinetics (PK, this measures the levels of study drug in the body) of a single injection of MMV371 in healthy adult and adolescent participants in Rwanda. MMV371 has been designed as a long acting injection (LAI). Protective efficacy (PE) will be assessed as an exploratory endpoint. Protective efficacy measures if participants are protected from becoming ill with malaria whilst the MMV371 is still present in their body. The study will enroll approximately 80 healthy male and female participants, aged 12 to 50 years. Before starting the study participants will be given a standard approved course of artemether lumifantrine (AL) to clear any malaria infection they have. Once the AL course has been completed the study drug will be given by injection in the muscle of the upper arm, the side of the thigh, or the hip. Three out of four participants will receive MMV371 and 1 in four participants will receive placebo. Placebo is a dummy medicine. All participants have an equal chance of being assigned to receive the injection in the upper arm, outer thigh or hip. Neither the participants nor the researchers treating the participants will know who received MMV371 or placebo until after the study is completed.\n\nKey study features include:\n\n* Study duration for each participant: up to 7 months\n* MMV371 or placebo given: a single intramuscular (IM) injection\n* Visit schedule: Participants will remain in-clinic on Days -1-2 (2 overnight stays), followed by 15 follow-up visits: Day 4, then weekly for 1 month, and subsequently every 2 weeks until the End-of-Study (EoS) visit at Week 24.\n\nThese frequent visits are necessary to monitor safety, the levels of MMV371 in the body, and to perform malaria detection testing until EoS (Week 24).",[27,137,138,139,140,141,142],"Malaria Falciparum","Malaria Infection","Malaria Prophylaxis","Malaria Prevention","Malaria","Malaria Parasitaemia",[144,145,146,147,148,149],"malaria prevention","malaria prophylaxis","malaria falciparum","Malaria infection","Malaria Long-Acting Injectable","Long-Acting Injectable","2026-04-17",{"date":152,"type":38},"2026-04-23",{"date":154,"type":21},"2026-09",{"date":156,"type":21},"2028-03",{"name":158,"class":45},"Medicines for Malaria Venture",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":54,"sex":16,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":173,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":46},"100598682","phase-2-dose-finding-trial-of-r21matrix-m-in-school-children-100598682","NCT07074665","Dose Finding Trial of R21\u002FMatrix-M in School Children","A Phase II Randomised Trial to Evaluate the Safety and Immunogenicity of a R21\u002FMatrix-M Booster Vaccine at Two Different Doses in Burkinabe School Children","Inclusion Criteria:\n\n* The child received four doses of R21\u002FMatrix-M in the phase IIb study evaluating R21\u002FMatrixM in Nanoro, Burkina Faso (VAC 076).\n* Signed informed consent\u002Fthumb-printed and witnessed informed consent obtained from the parent(s)\u002Fguardian(s) of the child to join the trial.\n* The investigator believes that the parents\u002Fguardians can and will comply with the requirements of the protocol if the child is enrolled in the study.\n* The child is a permanent resident of the study area and is expected to remain a resident for the duration of the trial.\n\nExclusion Criteria:\n\n* The child is enrolled in another malaria vaccine trial.\n* The child has a history of allergic disease or reactions likely to be exacerbated by any component of the malaria vaccine.\n* The child has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunisations.\n* The child has major congenital defects.\n* The child has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g\u002FdL.\n* The child has been administered immunoglobulins and\u002For any blood products within the three months preceding the planned administration of the vaccine candidate.\n* The child has malnutrition requiring hospital admission.\n* The child has an acute or chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests.\n* Children currently meeting the WHO criteria for HIV disease of stage 3 or 4 severity. A previous history of stage 3 or 4 disease is not an exclusion. Note: There will be no routine testing for HIV. Positive diagnoses will be recorded at screening if known.\n* The child has received an investigational drug or investigational vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* The child is currently participating in another clinical trial if likely to affect data interpretation of this trial.\n* The child has any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.","6 Years","8 Years",{"count":169,"type":21},40,[24],"This trial is a double-blind, randomised, trial recruiting participants from the R21 phase IIb trial (VAC 076) which took place between May 2019 and July 2023 in Nanoro, Burkina Faso.\n\nParticipants (n=30-40) who have previously received four doses of the 5µg R21\u002F50µg Matrix-M malaria vaccine in VAC 076 will be randomised to receive either 5µg R21\u002F50µg Matrix-M or 10µg R21\u002F50µg Matrix-M. Safety and immunogenicity of a booster at school age at these two different doses will be assessed. Participants will be followed up for one year after the booster.",[27],[174,175],"Malaria Vaccine","R21\u002FMatrix-M","2026-02-19",{"date":178,"type":38},"2026-02-23",{"date":180,"type":38},"2026-02-18",{"date":182,"type":21},"2027-03",{"name":184,"class":45},"University of Oxford"]