[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malaria-fever\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malaria-fever":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100628079","non-invasive-malaria-diagnostic-data-collection-in-ethiopia-100628079",false,"NCT07456969","Non-invasive Malaria Diagnostic Data Collection in Ethiopia","Data Collection Support for a Non-invasive Malaria Diagnostic Tool Using Volatile Organic Compounds (VOC) in Gondar, Ethiopia","Inclusion Criteria:\n\nAged 12 years or older\n\nPresenting at the study site with fever (37.5 degrees and above)\n\nFreely agreeing to participate by providing informed consent (and assent, if applicable)\n\nExclusion Criteria:\n\nPresence of symptoms and signs of severe illness and\u002For central nervous system infections.\n\nPresenting with any condition that prevents adequate breath collection:\n\nAsthma\n\nChronic Obstructive Pulmonary Disease (COPD)\n\nSevere respiratory illness\n\nInability to follow instructions\n\nPatient lacking capacity to provide informed consent.\n\nPrior antimalarial treatment within the last 14 days.",true,"ALL","12 Years",{"count":20,"type":21},200,"ESTIMATED","1 Day","OBSERVATIONAL","This project supports the development of a non-invasive diagnostic tool for malaria, focusing on validating the link between VOCs (volatile organic compounds) and malaria infection using thermodynamic sensors. This technology aims to provide rapid, painless alternatives to blood-based diagnostics, enabling malaria detection without invasive sampling.\n\nTrace Sensing has already identified six potential VOC biomarkers based on published literature specific for malaria. Two of these are part of the company's existing library and can already be detected in purified form by the TRACE-E device, while the others are under active evaluation. To confirm the suitability of the selected VOC biomarkers for diagnosing malaria and strengthen the detection algorithm, high-quality, robust clinical data from well-characterized biological specimens are required. In partnership with Gondar University in Ethiopia, breath samples will be collected from individuals (12 years and older) suspected of having malaria presenting at two health clinics. PCR performed on blood samples will serve as reference method to confirm infection status, while non-invasive clinical breath tests will be performed using the TRACE-E device.\n\nThe resulting data will confirm whether the six candidate malaria VOC biomarkers can be detected in patient breath, and if other VOC biomarkers can be detected as well. This study will therefore act as a malaria VOC biomarker confirmation study.",[26],"Malaria Fever","NOT_YET_RECRUITING","2026-03-03",{"date":30,"type":31},"2026-03-09","ACTUAL",{"date":33,"type":21},"2026-04",{"date":35,"type":21},"2026-09",{"name":37,"class":38},"Foundation for Innovative New Diagnostics, Switzerland","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100602488","phase-1-a-challenge-study-to-assess-the-blood-stage-efficacy-of-full-length-sum-101-malaria-vaccine-candidate-100602488","NCT07124156","A Challenge Study to Assess the Blood-stage Efficacy of Full-length SUM-101 Malaria Vaccine Candidate","A Randomised Phase Ib Trial to Assess the Blood-stage Efficacy of SUM-101 Malaria Vaccine in Adults Residing in Malaria-endemic Settings, After Controlled Human Malaria Infection Using 3D7 P. Falciparum Blood-stage Malaria Infection","CHMI-SUM-101","Inclusion Criteria:\n\n* Written informed consent obtained before any study procedure.\n* Literate participants aged ≥18 - ≤45 years of African origin.\n* Female and male participants willing to practice effective contraception from 4 weeks before 1st vaccination (female participants only) and up to 12 weeks after the last vaccination or CHMI (female and male participants)\n* Female participants must be willing to undergo multiple serum pregnancy tests.\n* Available to participate in follow-up for the duration of the study, including the CHMI in-patient confinement period.\n* Contactable by phone during the whole study period.\n* At least two years of residence in the Bagamoyo district or nearby districts in the Coastal and Dar-es-Salaam regions and planning to reside there for at least 9 more months.\n* Agreement to provide personal contact information and contact information of another household member or close friend.\n* Confirmation of understanding of design, procedures, risks and benefits of the study by scoring 10 out of 10 in a structured ten questions with a maximum of two attempts.\n* General good health based on assessment of medical history and clinical examination.\n* The volunteer agrees to refrain from blood donation for 12 months following CHMI.\n* Volunteer agrees to refrain from intensive physical exercise (disproportionate to the volunteer's usual daily activity or exercise routine) during the malaria challenge period.\n\nExclusion Criteria:\n\n* Previous participation in any malaria vaccine trial in the last 3 years.\n* Participation in any other clinical trial involving investigational medicinal products within 30 days prior to the screening assessment.\n* Previous history of drug or alcohol abuse interfering with normal social function within one year prior to enrolment.\n* Previous vaccination with a rabies vaccine.\n* High anti-schizont antibody level as measured by ELISA at screening.\n* Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating drugs) during the 13 weeks preceding the screening visit or during the study period.\n* Known hypersensitivity to any of the vaccine components (adjuvant or protein) or anti-malarial treatments.\n* Body mass index (BMI) of ≤18 or ≥30 Kg\u002Fm2.\n* Participants are unable to be closely followed for social, geographic or psychological reasons.\n* Any vaccination from 4 weeks prior to the 1st vaccination and (none planned) up to 8 weeks after the 3rd vaccination.\n* Any history, or evidence at screening, of clinically significant symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, neurological, psychiatric, allergy, endocrine, malignant, haematological, infectious disease, epilepsy and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the participants.\n* Abnormal electrocardiogram on screening: pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, clinically significant arrhythmias, left bundle branch block, secondary or tertiary A-V (atrio-ventricular) heart block.\n* Any clinically significant laboratory values at screening outside of normal ranges for study participants.\n* Malaria positivity at screening (microscopy or qPCR positive).\n* Positive HIV, Hepatitis B (HBV) or Hepatitis C (HCV) tests. (The testing will only be requested on the discretion of clinician)\n* For females: Positive pregnancy test or actively breastfeeding.\n* Any recent or current systemic therapy with an antibiotic or drug with potential antimalarial activity (chloroquine, doxycycline, tetracycline, piperaquine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin, erythromycin, hydroxychloroquine, etc.) (allowable time frame for use at investigators discretion or within a month prior to 1st vaccination or CHMI )\n* History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.\n* Known hypersensitivity to or contra-indications (including co-medication) for use of chloroquine, artemether-lumefantrine, Primaquine or history of severe (allergic) reactions to blood transfusion.\n* Being an employee or relative of an employee of Ifakara Health Institute.\n* Any other condition or situation that would, in the opinion of the investigator, place the volunteer at an unacceptable risk of injury or render the volunteer unable to meet the requirements of the protocol","18 Years","45 Years",{"count":50,"type":21},24,"INTERVENTIONAL",[53],"PHASE1","The goal of the study is to test the efficacy using a homologous CHMI of this vaccine candidate early in the development path in a population living in malaria-endemic areas.\n\nIn the previous Phase Ia and Ib trials, no efficacy endpoints were defined, and therefore there is currently no data on the SUM-101 vaccine efficacy. The proposed clinical trial will enrol malaria pre-exposed healthy adults and will be the second trial where the IMP will be administered to healthy adult participants in Tanzania with some pre-existing immunity against malaria.\n\nThe vaccination part of this study will be performed in a randomised, double-blinded, controlled design to evaluate the safety, reactogenicity and immunogenicity of the candidate malaria vaccine SUM-101 (MSP1 with GLA-SE as adjuvant). Given that SUM-101 is a malaria vaccine with an important blood-stage component, we propose to use CHMI with the 3D7 P. falciparum strain-infected red blood cells to establish initial vaccine efficacy data after the third vaccination in a malaria-exposed population.",[26],[57,58,59],"SUM-01","CHMI","Malaria","2025-11-20",{"date":62,"type":31},"2025-11-21",{"date":64,"type":21},"2026-03-20",{"date":66,"type":21},"2026-12-31",{"name":68,"class":38},"European Vaccine Initiative"]