[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100088705":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":26,"locations":38,"responsibleParty":90,"collaborators":92,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":26,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":26,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":120,"whyStopped":26,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","Three doses of MRKAd5 HIV-1 gag\u002Fpol\u002Fnef vaccine",[13],"Biological: MRKAd5 HIV-1 gag\u002Fpol\u002Fnef",{"label":15,"type":16,"description":17,"interventionNames":18},"2","PLACEBO_COMPARATOR","Placebo",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","MRKAd5 HIV-1 gag\u002Fpol\u002Fnef","Experimental Clade-B based Adenovirus serotype 5 HIV-1 gag\u002Fpol\u002Fnef vaccine",[9],null,{"type":28,"name":17,"description":17,"armGroupLabels":29,"otherNames":26},"OTHER",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Glenda Gray, MD","Chris Hani Baragwanath Hospital","STUDY_CHAIR",{"name":36,"affiliation":37,"role":34},"James Kublin, MD, MPH","Fred Hutchinson Cancer Center",[39,52,61,71,81],{"facility":40,"status":26,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":26},"Soweto HVTN CRS","Johannesburg","Gauteng","1862","South Africa","ZA",{"type":47,"coordinates":48},"Point",[49,50],28.04363,-26.20227,{"lat":50,"lon":49},{"facility":53,"status":26,"city":54,"state":42,"zip":55,"country":44,"countryCode":45,"cosmosGeoPoint":56,"geoPoint":60,"contacts":26},"MedCRU CRS","Pretoria","0204",{"type":47,"coordinates":57},[58,59],28.18783,-25.74486,{"lat":59,"lon":58},{"facility":62,"status":26,"city":63,"state":64,"zip":65,"country":44,"countryCode":45,"cosmosGeoPoint":66,"geoPoint":70,"contacts":26},"eThekwini CRS","Durban","KwaZulu-Natal","4001",{"type":47,"coordinates":67},[68,69],31.0292,-29.8579,{"lat":69,"lon":68},{"facility":72,"status":26,"city":73,"state":74,"zip":75,"country":44,"countryCode":45,"cosmosGeoPoint":76,"geoPoint":80,"contacts":26},"Emavundleni CRS","Cape Town","Western Cape","7750",{"type":47,"coordinates":77},[78,79],18.42322,-33.92584,{"lat":79,"lon":78},{"facility":82,"status":26,"city":83,"state":26,"zip":84,"country":44,"countryCode":45,"cosmosGeoPoint":85,"geoPoint":89,"contacts":26},"CAPRISA Aurum CRS","Klerksdorp","2571",{"type":47,"coordinates":86},[87,88],26.66672,-26.85213,{"lat":88,"lon":87},{"type":91,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[93],{"name":94,"class":95},"HIV Vaccine Trials Network","NETWORK","100088705","phase-2-safety-and-efficacy-of-a-three-dose-regimen-of-an-adenoviral-hiv-vaccine-mrkad5-hiv-1-gagpolnef-in-hiv-uninfected-south-african-adults-100088705",false,"NCT00413725","Safety and Efficacy of a Three-Dose Regimen of an Adenoviral HIV Vaccine (MRKAd5 HIV-1 Gag\u002FPol\u002FNef) in HIV Uninfected South African Adults","A Multicenter Double-Blind Randomized Placebo-Controlled Phase IIB Test-of-Concept Study to Evaluate the Safety and Efficacy of a Three-Dose Regimen of the Clade B-based Merck Adenovirus Serotype 5 HIV-1 Gag\u002FPol\u002FNef Vaccine in HIV-1 Uninfected Adults in South Africa","As of 9\u002F19\u002F07, clinical research sites were notified that HVTN 503 has been suspended; therefore, enrollment is discontinued and all participants will be unblinded and encouraged to continue follow-up visits.\n\nInclusion Criteria:\n\n* HIV-1 and -2 negative\n* Good general health\n* ALT less than 2.6 times the upper limit of normal (ULN)\n* Sexually active within the 6 months prior to study entry\n* Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed during the study\n* Demonstrate understanding of the study\n* Willing to receive HIV test results\n* Female participants must be willing to use acceptable forms of contraception, or not be of reproductive potential. More information about this criterion can be found in the protocol.\n\nExclusion Criteria:\n\n* Adenovirus 5 titer greater than 200, once enrollment of participants in this stratum has been completed\n* HIV vaccines in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.\n* Immunosuppressive medications within 168 days prior to first study vaccination. Participants who have used corticosteroid nasal sprays for allergic rhinitis or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.\n* Blood products within 90 days prior to first study vaccination\n* Immunoglobulin within 90 days prior to first study vaccination\n* Live attenuated vaccines within 30 days prior to first study vaccination\n* Investigational research agents within 30 days prior to first study vaccination\n* Medically indicated subunit or killed vaccines within 5 days prior to first study vaccination OR scheduled to receive such vaccines within 14 days after first study vaccination\n* Allergy treatment with antigen injections within 30 days prior to first study vaccination\n* Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.\n* Any medical, psychiatric, or job-related responsibility that would interfere with the study. More information about this criterion can be found in the protocol.\n* Any concern that, in the opinion of the investigator, may interfere with a participant's completion of the post-vaccination symptom log\n* History of anaphylaxis or allergy to any of the vaccine's components\n* Autoimmune disease\n* Immunodeficiency\n* Bleeding disorder\n* Cancer\n* Seizure disorder\n* Pregnancy or breastfeeding",true,"ALL","18 Years","35 Years",{"count":108,"type":109},801,"ACTUAL","INTERVENTIONAL",[112],"PHASE2","The purpose of this study is to determine the safety, efficacy, and tolerability of a three-dose regimen of an adenovirus-based HIV-1 vaccine in healthy South African adults.",[115],"HIV Infections",[117,118,119],"HIV Seronegativity","HIV Preventive Vaccine","Adenovirus","COMPLETED","2021-10-13",{"date":123,"type":109},"2021-10-15",{"date":125,"type":26},"2007-01",{"date":127,"type":109},"2012-08",{"name":5,"class":6},5]