[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malaria-vaccine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malaria-vaccine":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100468485","phase-2-a-safety-immunogenicity-and-efficacy-study-of-pvriimatrix-m-in-healthy-thai-adults-living-in-thailand--mist3--100468485",false,"NCT05380388","A Safety, Immunogenicity and Efficacy Study of PvRII\u002FMatrix-M in Healthy Thai Adults Living in Thailand ( MIST3 )","A Phase II Clinical Study to Assess the Safety, Immunogenicity, and Efficacy of Blood-stage Plasmodium Vivax Malaria Vaccine Candidate PvRII\u002FMatrix-M in Healthy Thai Adults Living in Thailand","MIST3","Inclusion Criteria:\n\n1. Healthy Thai adults aged 20 to 55 years\n2. Minimum educational level of high school or equivalent\n3. Red blood cells positive for the Duffy antigen\u002Fchemokine receptor (DARC)\n4. Women only: Must practice continuous effective contraception for the duration of the study period until 3 months post-challenge.\n5. Agreement to refrain from blood donation during the study and for 1 year after the initiation of antimalarial treatment.\n6. Willing to be admitted to the Hospital for Tropical Diseases for clinical monitoring as required by the protocol until antimalarial treatment is completed and their symptoms are settling, willing to take a curative antimalarial treatment following CHMI, and willing to reside in Bangkok and its vicinity for 2 months after malarial treatment initiation.\n7. Able to read and write in Thai.\n8. Provide written informed consent to participate in the trial\n9. Answer all questions on the informed consent quiz correctly\n10. Completed COVID-19 vaccination with 2 doses of any WHO-approved vaccine\n\nExclusion Criteria:\n\n1. Positive malaria qPCR OR malaria film prior to vaccination and challenge\n2. Presence of any medical condition (either physical or psychological) that, in the judgment of the investigator, would place the participant at undue risk (including the history of clinically significant contact dermatitis) or interfere with the results of the study (e.g., underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition)\n3. Presence of chronic disease or chronic use of medication\n4. Prior receipt of other investigational vaccine which is likely to impact the interpretation of the trial data as assessed by the Investigator.\n5. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, history of splenectomy, recurrent severe infections, and chronic infection\n6. Immunosuppressant medication within the past 6 months preceding enrolment (D0) or plan to use during the study (inhaled and topical steroids are allowed)\n7. History of allergic disease or reactions likely to be exacerbated by malaria infection\n8. Female participant who is pregnant as evidenced by positive beta-human chorionic gonadotropin (β-HCG) test, or who is lactating or planning pregnancy during the course of the study.\n9. Contraindications to the use of antimalarial treatment (e.g., chloroquine, atovaquone\u002Fproguanil, or dihydroartemisinin\u002Fpiperaquine)\n10. Use of medications known to have potentially clinically significant interaction with the antimalarial drugs that will be used in this study (chloroquine, atovaquone\u002Fproguanil, or dihydroartemisinin\u002Fpiperaquine)\n11. History of cardiac arrhythmia, including clinically relevant bradycardia or Known existing positive family history in both 1st AND 2nd-degree relatives \\\u003C 50 years old for cardiac disease\n12. Family history of congenital QT prolongation or sudden death\n13. Any clinical condition, including using medications known to prolong the QT interval or screening electrocardiogram (ECG), demonstrates a QTc interval ≥ 450 ms.\n14. Suspected or known history of alcohol abuse or history of drug abuse.\n15. Concurrently participating in another clinical study, at any time during the study period\n16. Positive hepatitis B surface antigen or seropositive for hepatitis C virus, or HIV\n17. Finding on safety laboratory values as defined below:\n\n    * Abnormal ALT \\[\\>upper normal range\\]\n    * Abnormal serum creatinine \\[\\>upper normal range\\]\n    * Clinically significant abnormalities in corrected calcium and magnesium blood levels\n    * Haemoglobin \\\u003C 11 g\u002FdL\n18. Blood group Rhesus negative\n19. Blood incompatibility to the inoculum\n20. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine\n21. Any history of anaphylaxis in reaction to vaccinations\n\nVaccination and re-vaccination exclusion criteria\n\n1\\. Acute disease at the time of vaccination. (acute disease is defined as the presence of a moderate or severe illness with or without fever).\n\nThe following adverse events associated with vaccine immunisation constitute absolute contraindications to further vaccine administration. If any of these events occur during the study, the participant must be withdrawn and followed until the resolution of the event, as with any adverse event:\n\n1. Anaphylactic reaction following administration of the vaccine\n2. Pregnancy\n\nExclusion criteria on the day of CHMI\n\nThe following constitute absolute contraindications to CHMI:\n\n1. Acute disease, defined as a moderate or severe illness with or without fever\n2. Pregnancy\n3. Use of systemic antibiotics with known antimalarial activity in the 30 days before challenge (e.g., trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, and azithromycin)",true,"ALL","20 Years","55 Years",{"count":22,"type":23},36,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","This project is the third part of a 5-year research program entitled \"Malaria Infection Studies in Thailand (MIST)\" and known as MIST3. MIST3's primary objectives are to assess the safety of the PvRII\u002FMatrix-M vaccine candidate in healthy adult Thai volunteers and to establish whether the PvRII\u002FMatrix-M vaccine can demonstrate a reduced parasite multiplication rate in vaccinated volunteers compared to a controlled group (placebo vaccine) in a blood-stage controlled human malaria infection model. This study will recruit up to 36 eligible healthy volunteers aged 20-55 in Thailand at the Faculty of Tropical Medicine, Mahidol University. Eighteen volunteers will receive three doses of the PvRII\u002FMatrix-M candidate vaccine, and 18 volunteers will receive three doses of the placebo vaccine. Safety and immunogenicity will be evaluated after each dose as per protocol. Approximately four weeks after receiving the third vaccination, 24 volunteers will undergo blood-stage CHMI with Plasmodium vivax. The volunteers will be monitored closely as in-patients in the Hospital for Tropical Diseases and treated according to the Research Proposal Submission Form.\n\nThis study is funded by the UK Wellcome Trust. The grant reference number are Oxford\u002FMORU: 212336\u002FZ\u002F18\u002FZ and 212336\u002FZ\u002F18\u002FA, and Mahidol University: 212336\u002FA\u002F18\u002FZ and 212336\u002FA\u002F18\u002FA",[29,30],"Plasmodium Vivax Infection","Malaria Vaccine","NOT_YET_RECRUITING","2026-03-23",{"date":34,"type":35},"2026-03-24","ACTUAL",{"date":37,"type":23},"2027-01-01",{"date":39,"type":23},"2027-12-30",{"name":41,"class":42},"University of Oxford","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":43},"100624963","effectiveness-of-malaria-vaccines-in-reducing-the-risk-of-invasive-non-typhoidal-salmonella-disease-100624963","NCT07416461","Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-typhoidal Salmonella Disease","Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-Typhoidal Salmonella Disease (VINS)","VINS","Inclusion Criteria:\n\n1. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR\n2. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation",{"count":53,"type":23},10000,"OBSERVATIONAL","The goal of this observational study is to learn about the impact of malaria vaccination on the risk of invasive non-typhoidal Salmonella disease in children below the age of 5. Eligible participants residing in the Kisantu Health Zone (DRC) and presenting fever are enrolled in healthcare facilities and tested for malaria and iNTS. Using a case-control (test-negative) design, the researchers will look at the malaria vaccination status of participants with and without iNTS infection to determine if the malaria vaccine protects against iNTS.",[57,58,30],"Invasive Non-Typhoidal Salmonella Disease","Malaria",[58,60,61,57,62,63,64,65,66],"Vaccine effectiveness","iNTS","DRC","Democratic Republic of Congo","Malaria vaccine","Effectiveness","R21\u002FMatrix-M","RECRUITING","2026-02-10",{"date":70,"type":35},"2026-02-18",{"date":72,"type":35},"2025-10-27",{"date":74,"type":23},"2027-02",{"name":76,"class":42},"International Vaccine Institute",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":17,"sex":18,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":24,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100582197","phase-4-integrating-malaria-vaccine-with-seasonal-malaria-chemoprevention-in-west-africa-100582197","NCT06860178","Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa","IMVACS","Inclusion criteria:\n\nControl arms :\n\n* Children aged 5-36 months in Burkina Faso and Mali at the time of first study vaccination;\n* Resident in the catchment area of a health centre assigned to the control arm;\n* Willingness to comply with the study procedures;\n* Written informed consent from Parent\u002FGuardian.\n\nIntervention arms :\n\n* Children aged 3-59 months at the time of first study vaccination;\n* Resident in the catchment area of a health centre assigned to the intervention arm;\n* Willingness to comply with the study procedures;\n* Written informed consent from Parent\u002FGuardian.\n\nExclusion Criteria:\n\n1. History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;\n2. Any history of anaphylaxis in relation to vaccination;\n3. Known chronic illness;\n4. Any other 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;\n5. History of vaccination with another malaria vaccine. -","3 Months","59 Months",{"count":87,"type":23},40000,[89],"PHASE4","This is a multi-site, multi-disciplinary, Phase-4 two-arm cluster-randomised non-inferiority trial in Burkina Faso and Mali to evaluate the eﬀectiveness and real-life impact of a novel integrated delivery strategy of the R21 malaria vaccine alongside SMC among children in areas with highly seasonal malaria transmission. In this study, a cluster is defined as the catchment area of a health centre. Clusters will be randomised to receive either year-round age-based routine EPI vaccination for children aged 5-36 months (\"Routine EPI Vaccination\") in Burkina Faso or an annual campaign of the 3-dose primary series in children aged 5-36 months prior to the malaria season and SMC delivery (''Routine Pre-SMC vaccination'') in Mali versus an annual campaign of the 3-dose primary series aligned with SMC distribution in children aged 3-59 months (\"Integrated SMC Vaccination\") in each country. Eﬀectiveness will be assessed in terms of clinical malaria, vaccine coverage, acceptability, feasibility, and cost-eﬀectiveness.\n\nMalaria incidence will be determined using routine surveillance activities for clinical malaria detection and reporting in each country. Cross-sectional surveys will be conducted to determine the prevalence of parasitaemia in the communities. In addition, the acceptability, feasibility, coverage and cost-effectiveness of the different delivery systems of R21\u002FMatrix-M will be assessed.",[30],[93,94,95,96,97],"malaria","CPS","pediatric","vaccine","R21","2025-08-05",{"date":100,"type":35},"2025-08-08",{"date":102,"type":35},"2025-06-10",{"date":104,"type":23},"2027-12",{"name":106,"class":42},"Epicentre",2]