[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100081144":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":22,"locations":28,"responsibleParty":42,"collaborators":44,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":22,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":22,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":79,"whyStopped":22,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"U.S. Army Medical Research and Development Command","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"10µg dose FMP011","EXPERIMENTAL","Falciparum Malaria Protein 11 with AS02A adjuvant",[13],"Biological: Falciparum Malaria Protein 11 with AS02A adjuvant",{"label":15,"type":10,"description":11,"interventionNames":16},"50µg dose FMP011",[13],[18],{"type":19,"name":11,"description":20,"armGroupLabels":21,"otherNames":22},"BIOLOGICAL","vaccine",[9,15],null,[24],{"name":25,"affiliation":26,"role":27},"James F Cummings, MD","Walter Reed Army Institute of Research (WRAIR)","PRINCIPAL_INVESTIGATOR",[29],{"facility":30,"status":22,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":22},"Walter Reed Army Institute of Research","Silver Spring","Maryland","20910","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-77.02609,38.99067,{"lat":40,"lon":39},{"type":43,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[45,48,51],{"name":46,"class":47},"GlaxoSmithKline","INDUSTRY",{"name":49,"class":50},"The PATH Malaria Vaccine Initiative (MVI)","OTHER",{"name":26,"class":6},"100081144","phase-1-phase-iii-trial-of-a-malaria-vaccine-in-adults-living-in-the-united-states-of-america-100081144",true,"NCT00312702","Phase I\u002FII Trial of a Malaria Vaccine in Adults Living in the United States of America","A Phase I\u002FIIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011\u002FAS02A Candidate Malaria Vaccine in Malaria-naive Adults Living in the United States","Inclusion Criteria:\n\n* A male or non-pregnant female 18 to 50 years of age (inclusive) at the time of screening.\n* Written informed consent obtained from the subject before screening procedures.\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\\*\n* Available to participate for duration of study (approximately 15 months).\n* If the subject is female, she must be currently using birth control, must be surgically sterilized, or must be at least 1-year post menopausal.\n* Pass a comprehension assessment test.\n\nExclusion Criteria:\n\n* Prior receipt of an investigational malaria vaccine.\n* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 28 days preceding the first dose of study vaccine, or planned use during the study period.\n* Administration of chronic immunosuppressants or other immune modifying drugs within six months of vaccination.\n* Chronic use of antibiotics with anti-malarial effects.\n* Planned administration\u002F administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).\n* History of use of anti-malarial medication within 60 days prior to vaccination.\n* Any history of malaria.\n* Known exposure to malaria within the previous 12 months.\n* Planned travel to malarious areas during the study period.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.\n* A family history of congenital or hereditary immunodeficiency.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* Chronic or active neurologic disease including seizures, but not including a single febrile seizure as a child.\n* History of splenectomy.\n* Acute disease at the time of enrollment.\n* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.\n* Personal history of autoimmune disease or subjects who describe a first-degree relative with clearly documented autoimmune disease.\n* Seropositive for hepatitis B surface antigen.\n* Seropositive for Hepatitis C virus (antibodies to HCV).\n* Administration of immunoglobulins and\u002For any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.\n* Pregnant or lactating female.\n* Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV.\n* Chronic or active intravenous drug use.\n* History of severe reactions to mosquito bites as defined as anaphylaxis.\n* Female who intends to become pregnant during the study.\n* Any history of anaphylaxis in reaction to vaccination.\n* A clinical history of sickle cell disease or sickle cell trait.\n* Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study.","ALL","18 Years","50 Years",{"count":63,"type":64},18,"ACTUAL","INTERVENTIONAL",[67,68],"PHASE1","PHASE2","Phase I\u002FII Trial of a Malaria Vaccine, FMP011\u002FAS01B, in Adults Living in the United States of America.",[71,72],"Malaria","Plasmodium Falciparum Malaria",[74,71,75,76,77,78],"Vaccine","Liver Stage Antigen-1","Falciparum Malaria Protein-11","AS02A","adjuvant","COMPLETED","2018-05-15",{"date":82,"type":64},"2018-11-26",{"date":84,"type":22},"2006-04",{"date":86,"type":64},"2007-04",{"name":5,"class":6},1]