[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malaria-prevention\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malaria-prevention":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,80,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100635079","phase-1-safety-and-pk-of-mmv371-lai-in-healthy-adults-and-adolescents-in-rwanda-100635079",false,"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.",true,"ALL","12 Years","50 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","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).",[28,29,30,31,32,33,34],"Malaria (Plasmodium Falciparum)","Malaria Falciparum","Malaria Infection","Malaria Prophylaxis","Malaria Prevention","Malaria","Malaria Parasitaemia",[36,37,38,39,40,41],"malaria prevention","malaria prophylaxis","malaria falciparum","Malaria infection","Malaria Long-Acting Injectable","Long-Acting Injectable","NOT_YET_RECRUITING","2026-04-17",{"date":45,"type":46},"2026-04-23","ACTUAL",{"date":48,"type":22},"2026-09",{"date":50,"type":22},"2028-03",{"name":52,"class":53},"Medicines for Malaria Venture","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":54},"100594590","early-phase-1-focal-mass-drug-administration-for-the-prevention-of-malaria-in-pregnancy-100594590","NCT07021430","Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy","Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy: a Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Primary residence (i.e., where a person lives for ≥ 6 months per year) in Kasese District with no plans to change residency in subsequent 6 months\n* Able and willing to comply with all study procedures and be available for the duration of the study\n* Able and willing to consent to study procedures as documented on informed consent form. For children (age \\\u003C18 years), parent or guardian must provide consent. Children age ≥8 to 17 years will also be asked to provide written assent.\n\nEach pregnant women will also need to meet additional eligibility criteria:\n\n18 years old or older Presenting to Bugoye Level III Health Center for antenatal care and plan to deliver at Bugoye Level III Health Center (i.e., not planned cesarean section) Gestational age ≤22 weeks Human Immunodeficiency Virus negative\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation:\n* Temporary or part-time residence in Kasese District (i.e., where a person lives for \\\u003C 6 months per year)\n* Known plans to move within the next 6 months\n* Unable or unwilling to provide consent\n* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study\n\nIn addition, individuals with any of the following will still be eligible to participate (e.g,, complete surveys, provide blood samples) but will not be eligible to receive Dihydroartemisinin Piperaquine if randomized to one of the intervention arms:\n\n* Known arrythmia, QT prolongation, or seizure disorder will not be eligible to receive Dihydroartemisinin Piperaquine\n* Use of potentially contraindicated medications outlined in Section 5.6\n* Weight \\\u003C5 kg\n* Known allergic reaction to Dihydroartemisinin Piperaquine or other Artemisinin Combination Therapies",{"count":63,"type":22},300,[65],"EARLY_PHASE1","The purpose of this study is to demonstrate the feasibility, acceptability, and preliminary effectiveness of a focal mass drug administration program for household members of pregnant women to protect against malaria in pregnancy.",[32],[33,69,70],"Focal mass drug administration","Dihydroartemisinin-piperaquine","2026-02-13",{"date":73,"type":46},"2026-02-17",{"date":75,"type":22},"2026-04",{"date":77,"type":22},"2028-04",{"name":79,"class":53},"University of North Carolina, Chapel Hill",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":16,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":54},"100622724","long-acting-spatial-emanators--repellents-laser-100622724","NCT07387341","Long-acting Spatial Emanators \u002F Repellents (LASER)","Long-acting Spatial Emanators \u002F Repellents (LASER) vs Indoor Residual Spraying (IRS) in Western Kenya: a Cluster-randomised Trial","LASER","The inclusion criteria are:\n\n1. Child aged 1-15 years\n2. Usual resident (a person who has been residing in the survey area for at least the past 4 months) who was present in the sampled household on the night before the survey\n3. Agreement of adult or parent\u002Fguardian (of children) to provide informed consent\n4. Agreement of child aged 12 years or older to provide assent\n\nThe exclusion criterion is:\n\n1\\. Child not at home after 3 attempts","1 Year","15 Years",{"count":91,"type":22},22815,[93],"NA","Malaria is a major problem in western Kenya, particularly around Lake Victoria. Whilst current prevention methods like bed nets and vaccines help to reduce malaria burden, additional tools are needed to better protect communities from malaria. The investigators will test a new technology called LASER Guardian™, which are devices that release chemicals to keep mosquitoes away from homes. The investigators will conduct a large study involving 69 villages in western Kenya over two years. Each village will be randomly chosen to receive one of three approaches: the new LASER devices, indoor residual spraying with insecticide (a method already known to work), or the standard prevention methods currently used. All villages will continue to receive the usual malaria prevention tools provided by the Kenyan government, including bed nets and vaccines. In villages receiving LASER, the investigators will install 2-3 small device inside structures once a year for two years. In villages receiving IRS, the investigators will spray the inside walls of homes with insecticide once a year for two years. The investigators want to find out if the LASER devices can reduce malaria better than current methods alone, and whether they work as well as indoor spraying. To do this, the investigators will carry out surveys of the community every six months over two years (four rounds in total), testing about 4,485 children between ages 1 and 15 from approximately 3,450 households in each survey to see how many have malaria. The investigators will also work with local health clinics to track malaria cases, study mosquitoes to understand how the interventions affect them, talk with community members about their experiences, and calculate the costs of these different approaches. This study will help us understand whether LASER tool can effectively protecting against malaria in Kenya and other African countries where malaria is common.",[96,32,33],"Malaria Transmission",[98,99,100,101],"spatial repellents","spatial emanators","Indoor Residual Spraying","Kenya","2026-01-27",{"date":104,"type":46},"2026-02-04",{"date":106,"type":22},"2026-01-17",{"date":108,"type":22},"2028-04-30",{"name":110,"class":53},"Liverpool School of Tropical Medicine",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":16,"sex":17,"minAge":119,"maxAge":19,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":54},"100621644","phase-2-phase-iiab-trial-of-pvcsmontanide-isa-51-malaria-vaccine-in-adults-in-choc-colombia-100621644","NCT07373301","Phase IIa\u002Fb Trial of PvCS\u002FMontanide ISA-51 Malaria Vaccine in Adults in Chocó, Colombia","Determination of the Protective Efficacy of the PvCS\u002FMontanide ISA-51 Vaccine Formulation Against Controlled Infection With Plasmodium Vivax Sporozoites","PvCS\u002FM51","Inclusion Criteria Age 18-50 years, male or female. Healthy adults, as determined by medical history, physical examination, and screening laboratory tests.\n\nAble and willing to provide written informed consent prior to any study procedure.\n\nAvailable for the full duration of the study, including follow-up through 12 months post-challenge.\n\nGroup-specific criteria:\n\nMalaria-naïve cohort: No prior malaria infection or residence in malaria-endemic areas; negative malaria serology at screening.\n\nSemi-immune cohort: Residence ≥ 5 years in a P. vivax-endemic area and documented or self-reported prior malaria exposure.\n\nScreening negative for HIV, hepatitis B surface antigen (HBsAg), and hepatitis C virus antibodies.\n\nFor women of childbearing potential:\n\nNegative pregnancy test at screening and prior to each vaccination and\u002For CHMI. Commitment to use effective contraception (hormonal, IUD, barrier methods, or abstinence) from screening through the end of follow-up.\n\nWillingness to comply with all study procedures, including repeated blood sampling, controlled human malaria infection (CHMI), and inpatient or outpatient monitoring as required.\n\nExclusion Criteria Previous participation in any malaria vaccine clinical trial or any controlled human malaria infection (CHMI) study.\n\nHistory of severe allergic reactions, including anaphylaxis, to vaccines or vaccine components such as Montanide ISA-51 VG, adjuvants, or synthetic peptides.\n\nClinically significant acute or chronic medical conditions that may increase risk or interfere with study participation, including but not limited to:\n\nCardiovascular disease Hepatic or renal impairment Neurological or psychiatric disorders Autoimmune diseases Hematologic abnormalities Immunodeficiency or immunosuppressive conditions Use of immunosuppressive therapies, systemic corticosteroids, antimalarial medications, or other agents that may interfere with vaccine immune responses within 30 days prior to enrollment.\n\nReceipt of immunoglobulins or blood products within 3 months prior to screening.\n\nPregnancy or breastfeeding at screening or planned pregnancy during the study period.\n\nParticipation in another clinical trial of an investigational product or device within 30 days prior to enrollment or planned participation during the study.\n\nAny clinically significant abnormality on screening laboratories, ECG, or physical examination that, in the investigator's judgment, could:\n\nPose a safety risk, Confound study results, or Impair adherence to study procedures. Any condition or circumstance that, in the investigator's opinion, could compromise volunteer safety or the integrity of the trial.","18 Years",{"count":121,"type":22},72,[123],"PHASE2","This clinical study will evaluate an investigational malaria vaccine called PvCS\u002FMontanide ISA-51 to determine whether it is safe and whether it can protect adults from infection with Plasmodium vivax, one of the main parasites that causes malaria. P. vivax malaria is common in tropical regions, including Colombia, and can lead to recurrent fever, anemia, and prolonged illness. Currently, no licensed vaccine effectively prevents P. vivax infection.\n\nThe investigational vaccine (PvCS) contains synthetic peptides derived from the circumsporozoite (CS) protein located on the surface of P. vivax sporozoites. The vaccine is formulated with the adjuvant Montanide ISA-51 to enhance the immune response. This study aims to assess the safety of the PvCS\u002FMontanide ISA-51 formulation and to determine whether it can prevent malaria after controlled exposure to the parasite.\n\nThis is a Phase IIa\u002Fb, randomized, double-blind, placebo-controlled clinical trial conducted by the Malaria Vaccine and Drug Development Center (MVDC\u002FCIV) in collaboration with ASOCLINIC IPS and the Pacific Health Institute (INSALPA) in Quibdó, Chocó, Colombia. A total of 72 healthy adults aged 18-50 years from malaria-endemic areas will participate.\n\nParticipants will be randomly assigned in a 2:1 ratio to receive either the PvCS\u002FMontanide ISA-51 vaccine or a placebo. The study product will be administered by intramuscular injection at months 0, 2, and 4. After each vaccination, participants will be monitored for side effects and provide blood samples to measure immune responses, including antibody levels and T-cell activity.\n\nApproximately one month after the third vaccination, participants will undergo a controlled human malaria infection (CHMI), during which they will be exposed to P. vivax through the bite of infected mosquitoes under strict medical supervision. Following exposure, participants will be monitored daily using blood tests to detect malaria at the earliest stage.\n\nIf malaria parasites are detected-or if 21 days pass without infection-participants will receive prompt, effective antimalarial treatment based on Colombian national guidelines. All participants will continue to be followed for up to 12 months after the challenge to ensure safety and assess long-term outcomes.\n\nPrimary goals of the study include:\n\nDetermining whether the PvCS\u002FMontanide ISA-51 vaccine prevents P. vivax infection after CHMI.\n\nMeasuring the time between exposure and first detection of parasites (pre-patent period).\n\nEvaluating the safety and tolerability of the vaccine.\n\nSecondary goals include:\n\nMeasuring immune responses generated by the vaccine. Exploring relationships between immune responses and protection from infection. The total duration of the study is expected to be approximately 30 months, including recruitment, immunizations, challenge procedures, and follow-up. Results will help determine whether this vaccine can safely protect adults against P. vivax malaria and guide planning for future larger-scale vaccine trials in endemic populations.",[126,127,32],"Plasmodium Vivax Malaria","Plasmodium Vivax Infection",[129,130,131,132,133,32,134,135,136,137,138],"PvCS Vaccine","Plasmodium vivax","Malaria Vaccine","Montanide ISA-51","Controlled Human Malaria Infection","Phase II Clinical Trial","Immunogenicity","Vaccine Efficacy","Colombia","Adult Volunteers","2026-01-20",{"date":141,"type":46},"2026-01-28",{"date":143,"type":22},"2026-01-19",{"date":145,"type":22},"2028-06-12",{"name":147,"class":53},"Malaria Vaccine and Drug Development Center"]