[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plasmodium-vivax-malaria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plasmodium-vivax-malaria":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,87,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100492338","phase-3-focal-mass-drug-administration-for-vivax-malaria-elimination-100492338",false,"NCT05690841","FocaL Mass Drug Administration for Vivax Malaria Elimination","FocaL Mass Drug Administration for Vivax Malaria Elimination (FLAME): a Pragmatic Cluster Randomized Controlled Trial in Peru","FLAME","Inclusion Criteria:\n\n1. Cluster eligibility\n\n   * Within 8 hours transport of Iquitos\n   * Incidence \\\u003C250\u002F1000 and \\>2 cases year prior to trial\n   * Population size (\\\u003C650)\n2. Chloroquine (CQ) eligibility\n\n   * Resides in neighboring household but within 200 m of Pv index case in the past 2 years\n   * Age ≥6 months old\n   * Present for intervention\n   * Adult ≥18 years old that provides informed consent\n   * A child ≥8 years and \\\u003C18 years old that provides informed assent and has informed consent from their parents\n   * A child ≥6 months old and \\\u003C8 years old that has informed consent from their parents\n3. Tafenoquine (TQ) eligibility\n\n   * Eligible to receive CQ\n   * Age ≥16 years old\n   * Adult ≥18 years old that provides informed consent\n   * A child ≥16 years and \\\u003C18 years old that provides informed assent and has informed consent from their parents\n4. Primaquine eligibility\n\n   * Eligible to receive CQ and ineligible to receive TQ\n   * Age ≥6 months old\n   * Adult ≥18 years old that provides informed consent\n   * A child ≥8 years and \\\u003C18 years old that provides informed assent and has informed consent from their parents\n   * A child ≥6 months old and \\\u003C8 years old that has informed consent from their parents\n5. Baseline evaluation and informed consent\n\n   -Villagers will be eligible to participate in surveys if they slept in a household in cluster randomized to control or focal mass drug administration (fMDA) for at least one night in the past four weeks\n6. Eligibility for fMDA\n\n   * High-risk villagers are defined as individuals residing in households that are within 200 meters of a Plasmodium vivax index case households from the prior 2 years (including individuals in the index case household) will be eligible to receive fMDA that cycle\n   * Villagers that were eligible but missed in the 1st round in a cycle, or become eligible in the next two months, will not be eligible to receive fMDA in the 2nd round in a cycle.\n\nExclusion Criteria:\n\n1. Chloroquine eligibility\n\n   * History of retinal or visual field changes\n   * Known hypersensitivity or adverse reaction to CQ\n   * Currently taking CQ or have taken CQ in the past four weeks\n   * Ineligible for TQ or PQ (see criteria below)\n   * Hemoglobin \\\u003C9 g\u002FdL\n2. Tafenoquine eligibility\n\n   * G6PD deficiency or intermediate status (defined as activity ≤6.0 UI\u002FgHb per SD biosensor)\n   * G6PD status unknown or refusal of G6PD status test\n   * Acute or severe malaria\n   * Pregnancy (known or identified by pregnancy test)\n   * Refusal of pregnancy test if new amenorrhea in the past 4 weeks\n   * Woman breastfeeding a child that is G6PD deficient or with unknown G6PD status\n   * Known hypersensitivity or adverse reaction to TQ or PQ\n   * Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks\n   * Hemoglobin \\\u003C 9 g\u002FdL\n3. Primaquine eligibility\n\n   * G6PD deficiency (defined as activity ≤4.0 UI\u002FgHb per SD biosensor)\n   * G6PD status unknown or refusal of G6PD status test\n   * Acute or severe malaria\n   * Pregnancy (known or identified by pregnancy test)\n   * Refusal of pregnancy test if new amenorrhea in the past 4 weeks\n   * Breastfeeding child with documented or unknown G6PD deficiency status\n   * Woman breastfeeding a child with documented or unknown G6PD deficiency status\n   * Known hypersensitivity or adverse reaction to TQ or PQ\n   * Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks\n   * Hemoglobin \\\u003C 9 g\u002FdL",true,"ALL",{"count":20,"type":21},7530,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","FLAME is an open-label cluster-randomized controlled trial that aims to determine the effectiveness of focal mass drug administration (fMDA) to reduce the incidence of Plasmodium vivax malaria in the Loreto Department in Peru. Standard interventions, including symptomatic and asymptomatic screening for malaria infections, provision of insecticide-treated bednets, and environmental transmission monitoring, will be compared to clusters of villages randomized to receive anti-malarial drugs.",[27,28],"Plasmodium Vivax Malaria","Malaria",[30,31,32,33,34],"Antimalarial drugs","Primaquine","Chloroquine","Tafenoquine","Parasitic disease","RECRUITING","2026-06-05",{"date":38,"type":39},"2026-06-09","ACTUAL",{"date":41,"type":39},"2024-10-14",{"date":43,"type":21},"2027-05-01",{"name":45,"class":46},"University of California, San Francisco","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":47},"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","50 Years",{"count":59,"type":21},72,[61],"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.",[27,64,65],"Plasmodium Vivax Infection","Malaria Prevention",[67,68,69,70,71,65,72,73,74,75,76],"PvCS Vaccine","Plasmodium vivax","Malaria Vaccine","Montanide ISA-51","Controlled Human Malaria Infection","Phase II Clinical Trial","Immunogenicity","Vaccine Efficacy","Colombia","Adult Volunteers","NOT_YET_RECRUITING","2026-01-20",{"date":80,"type":39},"2026-01-28",{"date":82,"type":21},"2026-01-19",{"date":84,"type":21},"2028-06-12",{"name":86,"class":46},"Malaria Vaccine and Drug Development Center",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":47},"100499810","phase-4-act-vs-cq-with-tafenoquine-for-p-vivax-mono-infection-100499810","NCT05788094","ACT vs CQ With Tafenoquine for P. Vivax Mono-infection","Does Artemisinin Combination Treatment Reduce the Radical Curative Efficacy of High Dose Tafenoquine for Plasmodium Vivax Malaria?","ACTQ","Inclusion Criteria:\n\n* Patients with P. vivax mono-infection as diagnosed by Rapid Diagnostic Test\n* Fever or history of fever in the previous 7 days\n* Quantitative G6PD activity ≥70% of the population median i.e., ≥6.1U\u002FgHb\n* Age \\> 18 years, Weight \\>35 kg\n* Ability to understand the study instructions and provide informed consent\n* Willing to be followed for 4 months and likely to adhere to the study protocol.\n\nExclusion Criteria:\n\n* Coincident P. falciparum malaria or other infections\n* Pregnancy\n* Lactation\n* Hb \\\u003C 8 g\u002FdL\n* Quantitative G6PD activity \\\u003C70% of the population median i.e., \\\u003C6.1U\u002FgHb\n* Severe malaria (as per WHO guideline)\n* History of allergic or haemolytic response to any of the study drugs",{"count":96,"type":21},606,[98],"PHASE4","In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020 ASTMH Annual Meeting) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019 NEJM; Watson et al. 2022a Elife). A tafenoquine dose of 450mg is predicted to provide \\>90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.",[28,101,27],"Malaria, Vivax",[103,104,105,28],"artemisinin combination treatment","tafenoquine","Plasmodium vivax malaria","2025-05-13",{"date":108,"type":39},"2025-05-16",{"date":110,"type":39},"2023-06-26",{"date":112,"type":21},"2026-08-31",{"name":114,"class":46},"Shoklo Malaria Research Unit",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":18,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"100416617","phase-4-southeast-asia-dose-optimization-of-tafenoquine-100416617","NCT04704999","Southeast Asia Dose Optimization of Tafenoquine","Optimizing the Dose of Tafenoquine for the Radical Cure of Plasmodium Vivax Malaria in Southeast Asia","SEADOT","Inclusion Criteria:\n\n* Patients with symptomatic P. vivax mono-infection as diagnosed by microscopy\n* Fever or history of fever in the previous 7 days\n* Quantitative G6PD activity ≥70% of the population median\n* Weight \\>10 kg and ≥2 years old\n* Ability to understand the study instructions and provide written informed consent.\n* Willing to be followed for 4 months\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactation\n* Hb \\\u003C 8 g\u002FdL\n* Severe malaria\n* Blood transfusion in the last 4 months\n* History of allergic response to an 8-aminoquinoline or the nationally recommended schizonticide (e.g., chloroquine, artemether-lumefantrine)\n* Any previous history of a haemolytic event Presence of any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study (e.g. chronic disease, medications that potentiate or inhibit CYP2D6 or CYP2C8 isoenzyme function)","2 Years",{"count":125,"type":21},700,[98],"Tafenoquine was recently approved by regulatory authorities in the USA and Australia. Tafenoquine is an alternative radical curative treatment to primaquine acting against the dormant liver stage of Plasmodium vivax (the hypnozoite). Tafenoquine (an 8-aminoquinoline) has the substantial advantage of single dosing as compared to a 14-day course of primaquine to achieve radical cure. The recommended tafenoquine dose is 300 mg, which was shown to be significantly worse in radical curative efficacy to a total primaquine dose of 3.5 mg\u002Fkg in Southeast Asia. The cure rate of tafenoquine 300 mg in Southeast Asian study sites was only 74%. The comparator 3.5 mg\u002Fkg total primaquine dose is the standard and most commonly used dose globally, but in Southeast Asia and the Western Pacific, higher doses of primaquine are needed for radical cure. This study aims to determine the optimal dose of tafenoquine in Southeast Asia.",[27],[68,130,131,33,132,133,134,135],"Relapse","8-aminoquinoline","Radical cure","Drug efficacy","Adults","Pediatrics","2025-03-03",{"date":138,"type":39},"2025-03-06",{"date":140,"type":39},"2024-07-22",{"date":142,"type":21},"2028-02-07",{"name":144,"class":46},"University of Oxford",5]