[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100066999":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":14,"centralContacts":7,"locations":22,"responsibleParty":52,"collaborators":7,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":7,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":7,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":77,"whyStopped":7,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",null,[9,12],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"BIOLOGICAL","VRC-HIVADV014-00-VP",{"type":10,"name":13,"description":7,"armGroupLabels":7,"otherNames":7},"VRC-HIVDNA016-00-VP",[15,19],{"name":16,"affiliation":17,"role":18},"Job Bwayo, MD, PhD","Kenya AIDS Vaccine Initiative, University of Nairobi","PRINCIPAL_INVESTIGATOR",{"name":20,"affiliation":21,"role":18},"Etienne Karita, MD","Project San Francisco",[23,34,42],{"facility":24,"status":7,"city":25,"state":7,"zip":7,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":7},"KEMRI, Ctr. for Geographic Medicine Research Coast at Kilifi","Kilifi","Kenya","KE",{"type":29,"coordinates":30},"Point",[31,32],39.84992,-3.63045,{"lat":32,"lon":31},{"facility":35,"status":7,"city":36,"state":7,"zip":7,"country":26,"countryCode":27,"cosmosGeoPoint":37,"geoPoint":41,"contacts":7},"KAVI, KNH at Kangemi","Nairobi",{"type":29,"coordinates":38},[39,40],36.81667,-1.28333,{"lat":40,"lon":39},{"facility":43,"status":7,"city":44,"state":7,"zip":7,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":51,"contacts":7},"Projet San Francisco","Kigali","Rwanda","RW",{"type":29,"coordinates":48},[49,50],30.05885,-1.94995,{"lat":50,"lon":49},{"type":53,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100066999","phase-1-safety-of-and-immune-response-to-an-adenoviral-hiv-vaccine-vrc-hivadv014-00-vp-with-or-without-a-plasmid-hiv-vaccine-vrc-hivdna016-00-vp-in-hiv-uninfected-adults-100066999",false,"NCT00124007","Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults","A Phase I, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine or the Multiclade HIV-1 Adenoviral Vector Vaccine Alone in Healthy Adult Volunteers Not Infected With HIV","Inclusion Criteria:\n\n* Willing to follow all the requirements of the study and available for follow-up for the duration of the study\n* Have understanding of the study and provide written informed consent\n* Willing to undergo HIV testing and counseling and willing to receive HIV test results\n* Willing to use acceptable forms of contraception\n\nExclusion Criteria:\n\n* HIV infected\n* Hepatitis B virus infected\n* Hepatitis C virus infected\n* Active or untreated syphilis\n* Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol.\n* Any clinically significant abnormality in history or upon examination (e.g., immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator) within 6 months prior to study entry\n* Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would make the volunteer unsuitable for the study\n* Live attenuated vaccines within 30 days prior to study entry OR plan to receive a live attenuated vaccine within 60 days after vaccination in this study\n* Subunit or killed vaccines within 14 days prior to study entry OR plan to receive a subunit or killed vaccine within 14 days after vaccination in this study\n* Blood transfusion or blood products within 120 days prior to study entry\n* Immunoglobulin within 60 days prior to study entry\n* Participation in another investigational product clinical trial in the 3 months prior to study entry OR expected to participate in another investigational trial during this study\n* Any other investigational HIV vaccine at any time\n* History of severe local or systemic reactogenicity to vaccines or history of severe allergic reactions\n* Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or suicidal thoughts within the 3 years prior to study entry\n* Uncontrolled hypertension\n* Pregnant, breastfeeding, or plan to become pregnant",true,"ALL","18 Years","50 Years",{"count":66,"type":67},114,"ACTUAL","INTERVENTIONAL",[70],"PHASE1","The purpose of this study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.",[73],"HIV Infections",[75,76],"HIV Seronegativity","HIV Preventive Vaccine","COMPLETED","2021-10-28",{"date":80,"type":67},"2021-11-01",{"date":82,"type":7},"2005-11",{"date":84,"type":67},"2007-04",{"name":5,"class":6},3]