[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malariafalciparum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malariafalciparum":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,70,92,115],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100589729","phase-1-a-study-to-assess-the-experimental-malaria-vaccines-r78c-and-rh51-combined-with-r21matrix-m-a-multi-stage-malaria-vaccine-100589729",false,"NCT06958198","A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21\u002FMatrix-M (a \"Multi-stage\" Malaria Vaccine)","A Phase Ib Age De-escalation, Open Label Study of the Safety and Immunogenicity of the Multi-stage Malaria Vaccine Candidate R21 + RH5.1 + R78C in Matrix-M™ in Adults Aged 18-35 Years and Children Aged 5-17 Months in Burkina Faso","VAC093","Inclusion Criteria:\n\nOnly participants who meet all the inclusion criteria will be enrolled into the trial:\n\n* Group 1: Healthy adult aged 18-35 years at the time of first study vaccination\n* Group 2-6: Healthy child aged 5-17 months at the time of first study vaccination\n* Group 1: Female participants must be non-pregnant (as demonstrated by a negative urine pregnancy .\n\ntest), and practice continuous effective contraception until three months after the final study vaccination\n\n* Participant or parent\u002Fguardian provides signed\u002Fthumb-printed informed consent\n* Participant (and parent\u002Fguardian for child participants) resident in the study area villages, and anticipated to be available for vaccination and the duration of follow-up -\n\nExclusion Criteria:\n\n* The participant may not enter the trial if ANY of the following apply:\n\n  * Clinically significant congenital abnormalities as judged by the PI or other delegated individual.\n  * Clinically significant skin disorder (psoriasis, contact dermatitis, etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.\n  * History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).\n  * Children with weight-for-age Z score of less than -3 or other clinical signs of malnutrition.\n  * History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation.\n  * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n  * Sickle cell disease.\n  * Clinically significant laboratory abnormality at grade 2 or above as judged by the PI or other delegated individual.\n  * Administration of immunoglobulins and\u002For any blood products within the three months preceding the planned administration of the vaccine candidate.\n  * Receipt of any vaccine in the 14 days preceding enrolment, or planned receipt of any other vaccine within 28 days following each study vaccination.\n  * History of vaccination with any malaria vaccine.\n  * Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.\n  * Suspected or known current alcohol misuse.\n  * Suspected or known injecting drug use in the 5 years preceding enrolment.\n  * Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.\n  * Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.\n  * Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV IgG) or HIV. For children, any history of vertical exposure to HIV infection.\n  * Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (for corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg\u002Fkg\u002Fday; inhaled and topical steroids are allowed).\n  * 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.\n\nVaccination and re-vaccination exclusion criteria:\n\nThe following adverse events associated with vaccine immunisation constitute absolute contraindications to further administration of vaccine. If any of these events occur during the study, the participant must be withdrawn and followed until resolution of the event, as with any adverse event:\n\n* Anaphylactic reaction following administration of vaccine.\n* Pregnancy.\n\nThe following adverse events constitute contraindications to administration of vaccine at that point in time; if any one of these adverse events occurs at the time scheduled for vaccination, the participant may be vaccinated at a later date, or withdrawn at the discretion of the Investigator. The participant must be followed until resolution of the event as with any adverse event:\n\n* Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever or symptoms suggestive of possible COVID-19 disease). All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection without fever, i.e. axillary temperature \\\u003C 37.5°C.\n* Temperature of \\>37.5°C (99.5°F) at the time of vaccination.",true,"ALL","5 Months","35 Years",{"count":22,"type":23},56,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and\u002For R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso.",[29],"Malaria,Falciparum","RECRUITING","2026-03-09",{"date":33,"type":34},"2026-03-11","ACTUAL",{"date":36,"type":34},"2025-09-15",{"date":38,"type":23},"2026-10",{"name":40,"class":41},"University of Oxford","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":5},"100593700","an-observational-study-to-assess-effectiveness-and-safety-of-the-r21matrix-m-malaria-vaccine-100593700","NCT07009847","An Observational Study to Assess Effectiveness and Safety of The R21\u002FMatrix-M Malaria Vaccine","A Case Control Study to Assess Effectiveness and Safety of The R21\u002FMatrix-M Malaria Vaccine","Inclusion Criteria:\n\nFor Cases- A male or female child eligible to have received R21\u002FMatrix-M Vaccine based on age. 2 Parent\u002Flegal guardian\u002F caregiver of the child willing to provide the written informed consent for their child's participation in the study.\n\n3 Parent\u002Flegal guardian\u002F caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel.\n\n4 Resident of the R21\u002FMatrix-M vaccine implementation area and brought to the study hospital \u002Fclinic or sub-site with clinical complaints. 5 Child meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).\n\nFor Controls- A male or female child eligible to have received R21\u002FMatrix-M Vaccine based on age. The matched control should have a date of birth within 60 days of that of the case.\n\n2\\. Parent\u002Flegal guardian\u002F caregiver of the child willing to provide the informed consent for their child's participation in the study.\n\n3\\. Parent\u002F legal guardian\u002F caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel 4. Resident of the R21\u002FMatrix-M vaccine implementation area and who would have sought treatment at the same hospital if they had developed symptoms. Resident will be defined as child and\u002For child's parents\u002F guardian\u002Fcaregiver eating and sleeping in a household in the location for most days of the week from past 6 months. The matched control should be residing in the same neighborhood as the respective case, but not from the same household.\n\nExclusion Criteria:\n\nFor Cases-\n\n1. Parent\u002Flegal guardian\u002F caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.\n2. Child not meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).\n3. Received one or more doses of RTS,S\u002FAS01 vaccine in the past.\n\nFor Controls-\n\n1. Parent\u002Flegal guardian\u002F caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.\n2. Child meeting any of the case definitions (Severe Malaria, Clinical Malaria).\n3. Child having history suggestive of clinical malaria in past 30 days (applicable for clinical malaria and severe malaria case-control studies only).\n4. Received one or more doses of RTS,S\u002FAS01 vaccine\u002Fs in the past.",{"count":51,"type":23},2308,"OBSERVATIONAL","This is an observational case-control study to assess the effectiveness of the R21\u002FMatrix-M vaccine against severe malaria, clinical malaria (in high transmission perennial areas), and to assess if the R21 vaccine recipients are at an increased risk of deaths (all-cause). Clinical malaria, severe malaria and death (all-cause) cases will be enrolled in study. For each case (severe or death) 4 controls matched for age and neighborhood will be enrolled whereas for clinical malaria case, 1 matched control will be enrolled.\n\n1. Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.\n2. Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases in high-transmission perennial areas caused by P. falciparum.\n3. Proportion of vaccinated and unvaccinated children in cases of death (all cause)\n4. Exploratory effectiveness endpoint: Proportion of vaccinated and unvaccinated children in the hospitalized clinical and severe malaria cases.",[29,55],"Morality",[57,58,59],"clinical malaria","severe malaria","death (all cause)","2025-08-12",{"date":62,"type":34},"2025-08-13",{"date":64,"type":34},"2025-06-16",{"date":66,"type":23},"2026-12-31",{"name":68,"class":69},"Serum Institute of India Pvt. Ltd.","INDUSTRY",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":24,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":42},"100500025","phase-1-a-study-to-test-experimental-blood-stage-malaria-vaccine-in-burkina-faso-100500025","NCT05790889","A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.","A Phase IIb Randomised Controlled Trial of the Safety, Immunogenicity and Efficacy of the Blood-stage Malaria Vaccine Candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in Infants Aged 5-17 Months in Burkina Faso.","Inclusion Criteria:\n\n1. Healthy infant aged 5-17 months at the time of first study vaccination\n2. Parent\u002Fguardian provides signed\u002Fthumb-printed informed consent\n3. Infant and parent\u002Fguardian resident in the study area villages and anticipated to be available for vaccination and follow-up for 12 months following last dose of vaccination.\n\nExclusion Criteria:\n\n* Clinically significant congenital abnormalities as judged by the PI or other delegated individual.\n* Clinically significant skin disorder (psoriasis, contact dermatitis etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.\n* Weight-for-age Z score of less than -3 or other clinical signs of malnutrition.\n* History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunization.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* Sickle cell disease.\n* Clinically significant laboratory abnormality as judged by the study clinician.\n* Administration of immunoglobulins and\u002For any blood products within the three months preceding the planned administration of the vaccine candidate.\n* Receipt of any vaccine in the 7 days preceding enrolment, or planned receipt of any other vaccine within 7 days following each study vaccination.\n* History of vaccination with another malaria vaccine.\n* Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.\n* Known maternal HIV infection (no testing will be done by the study team).\n* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (for corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg\u002Fkg\u002Fday; inhaled and topical steroids are allowed).\n* 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.","17 Months",{"count":79,"type":23},480,[26,81],"PHASE2","This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso",[29],"2025-03-04",{"date":86,"type":34},"2025-03-07",{"date":88,"type":34},"2023-04-03",{"date":90,"type":23},"2026-05-30",{"name":40,"class":41},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":17,"sex":18,"minAge":99,"maxAge":20,"enrollmentInfo":100,"targetDuration":4,"studyType":24,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100538630","phase-1-durability-of-protection-after-single-immunisation-with-ga2-sporozoites-coga-rechallenge-100538630","NCT06293339","Durability of Protection After Single Immunisation With GA2 Sporozoites (CoGA-Rechallenge)","Durability of Protection After Single Immunisation With Genetically Attenuated Plasmodium Falciparum ∆mei2 (GA2) Sporozoites - a Follow-up, Controlled Human Malaria Rechallenge Study","Inclusion Criteria:\n\n1. Participant is aged ≥18 and ≤35 years and in good health.\n2. Rechallenge group only: participation in CoGA study, having received immunisation with 1x 50 GA2-infected MB, and protected during subsequent CHMI.\n3. Participant has adequate understanding of the procedures of the study and agrees to abide strictly thereby.\n4. Participant is able to communicate well with the investigator.\n5. Participant is available to attend all essential study visits.\n6. Participant agrees that his\u002Fher general practitioner (GP) will be informed about participation in the study.\n7. Participant agrees to refrain from blood donation to Sanquin or for other purposes. throughout the study period and for a defined period thereafter according to Sanquin guidelines.\n8. Participants of child bearing potential (i.e., have an uterus and are neither surgically sterilized nor post-menopausal) agree to use adequate contraception and to not breastfeed for the duration of study.\n9. Participant agrees to refrain from intensive physical exercise (disproportionate to the participants' usual daily activity or exercise routine) for twenty-one days following the immunization and during the malaria challenge period.\n10. Participant signs informed consent.\n\nExclusion Criteria:\n\n1. Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions which could compromise the health of the participant during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following:\n\n   a. Body Mass Index (BMI) \\>35.0 kg\u002Fm2 at screening. b. An elevated risk of cardiovascular disease, defined as: i. An estimated ten-year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation 2 (SCORE2) .\n\n   ii. History, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or iii. A positive family history of cardiac events in first- or second-degree relatives (according to the system used in medical genetics) \\\u003C50 years old.\n\n   b. Known functional asplenia, sickle cell trait\u002Fdisease, thalassemia trait\u002Fdisease or G6PD deficiency.\n\n   c. History of epilepsy in the period of five years prior to study onset, even if no longer on medication.\n\n   d. Positive HIV, HBV or HCV screening tests. e. Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other drugs that might have an influence on the immune system (excluding inhaled and topical corticosteroids and incidental use of oral anti-histamines), within three months prior to study onset or expected use of such during the study period.\n\n   f. Skin disease affecting the site of administration in such a way that administration of mosquito bites is deemed impossible by investigator.\n\n   g. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years.\n\n   h. Any history of treatment for severe psychiatric disease by a psychiatrist in the past year.\n\n   i. History of drug or alcohol abuse interfering with normal social functioning in the period of one year prior to study onset, positive urine toxicology test for cocaine or amphetamines at screening.\n2. For participants of child bearing potential: breastfeeding, or positive serum pregnancy test prior to CHMI.\n3. Infection controls only: any history of malaria or previous participation in any malaria (vaccine) study or CHMI.\n4. Known hypersensitivity to or contra-indications for both atovaquone\u002Fproguanil or artemether\u002Flumefantrine. QT prolonging drugs are only considered an exclusion criterion when QT prolongation is observed at the ECG at screening.\n5. A history of severe (allergic) reactions to mosquito bites.\n6. Participation in any other clinical study assessing an investigational medical product in the 30 days prior to the start of the study or during the study period.\n7. Any condition or situation that could influence the independent consent of participant (e.g. being a direct colleague or family member of study personnel).\n8. Any other condition or situation that would, in the opinion of the investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol or would compromise the integrity of the data.","18 Years",{"count":101,"type":23},14,[26],"This study will assess the durability of protection of a single immunisation with the Genetically Attenuated Parasite 2 (GA2) against controlled human malaria infection by rechallenging previously immunised and protected participants from the CoGA study (NCT05468606)",[29],"NOT_YET_RECRUITING","2024-12-20",{"date":108,"type":34},"2024-12-27",{"date":110,"type":23},"2025-03-01",{"date":112,"type":23},"2025-09-30",{"name":114,"class":41},"Leiden University Medical Center",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":17,"sex":18,"minAge":99,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":24,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":134,"locationsCount":4},"100500818","phase-2-addressing-asymptomatic-plasmodium-reservoirs-to-accelerate-malaria-elimination-and-eradication-in-rwanda-100500818","NCT05801198","Addressing Asymptomatic Plasmodium Reservoirs to Accelerate Malaria Elimination and Eradication in Rwanda.","Addressing Both Naturally Occurring and ACT-induced Plasmodium Reservoirs Using Artemisia Infusions to Accelerate Malaria Elimination and Eradication in Rwanda: A Proof of Concept Randomized Controlled Trial","Inclusion Criteria:\n\n* Confirmed as asymptomatic reservoir of Plasmodium in the community or after completing standard malaria treatment.\n* Leave for at least one month in Rwanda for non-national\n* Be between 18 and 65 years of age, and in good general health.\n* Not taking any other malaria drug for prevention or treatment.\n* Children 5 years and above will be recruited as index cases for household cluster survey.\n\nExclusion Criteria:\n\n* Have known hypersensitivity to any ingredients of the test treatment.\n* Have participated in any other malaria drug trial or device less than 14 days before.\n* History or presence of clinically significant medical, psychiatric, or emotional condition that would compromise the safety of the subject or adherence to the interventional requirements.\n* Be pregnant","65 Years",{"count":124,"type":23},125,[81],"The investigators believe that to effectively achieve malaria elimination in Rwanda, it is critical to target the human reservoirs of Plasmodium falciparum using local and readily available Artemisia tea. Asymptomatic infections detectable by PCR are important reservoirs because they often persist for months and harbor gametocytes, the parasite stage infectious to mosquitoes. Lessons learnt from this study will be of critical importance for health decision makers with regard to potential malaria control. MSc and PhD students will be trained and the impact of this research project will be enormous on the socioeconomic transformation of Rwanda.",[29],"2023-10-14",{"date":130,"type":34},"2023-10-17",{"date":132,"type":23},"2024-03-01",{"date":66,"type":23},{"name":135,"class":41},"King Faisal Hospital Rwanda"]