[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100081141":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":23,"locations":29,"responsibleParty":43,"collaborators":45,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":23,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":23,"studyType":66,"phases":67,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":81,"whyStopped":23,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"U.S. Army Medical Research and Development Command","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"10ug dose FMP011","EXPERIMENTAL","Falciparum Malaria Protein 11 with AS01B adjuvant",[13],"Biological: Falciparum Malaria Protein 11 with AS01B adjuvant.",{"label":15,"type":10,"description":11,"interventionNames":16},"50ug dose FMP011",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"BIOLOGICAL","Falciparum Malaria Protein 11 with AS01B adjuvant.","malaria experimental vaccine",[9,15],null,[25],{"name":26,"affiliation":27,"role":28},"James F. Cummings, MD","Walter Reed Army Institute of Research (WRAIR)","PRINCIPAL_INVESTIGATOR",[30],{"facility":31,"status":23,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":23},"Walter Reed Army Institute of Research","Silver Spring","Maryland","20910","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-77.02609,38.99067,{"lat":41,"lon":40},{"type":44,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[46,49,52],{"name":47,"class":48},"GlaxoSmithKline","INDUSTRY",{"name":50,"class":51},"The PATH Malaria Vaccine Initiative (MVI)","OTHER",{"name":27,"class":6},"100081141","phase-1-phase-iii-trial-of-a-malaria-vaccine-in-adults-living-in-the-united-states-of-america-100081141",true,"NCT00312663","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\u002FAS01B 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":64,"type":65},24,"ACTUAL","INTERVENTIONAL",[68,69],"PHASE1","PHASE2","Phase I\u002FII Trial of a Malaria Vaccine, FMP011\u002FAS01B, in Adults Living in the United States of America.",[72],"Plasmodium Falciparum Malaria",[74,75,76,77,78,79,80],"Vaccine","Phase I\u002FII","Malaria","Liver Stage Antigen -1","Falciparum Malaria Protein -11","AS01B","adjuvant","COMPLETED","2018-05-03",{"date":84,"type":65},"2018-11-26",{"date":86,"type":23},"2006-04",{"date":88,"type":65},"2007-04",{"name":5,"class":6},1]