[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100066996":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":57,"centralContacts":43,"locations":62,"responsibleParty":95,"collaborators":97,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":43,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":43,"studyType":115,"phases":116,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":125,"whyStopped":43,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,15,19,25,29,33],{"label":9,"type":10,"description":11,"interventionNames":12},"1A","EXPERIMENTAL","Participants will receive a low dose of the adenovirus-vectored HIV vaccine or placebo at study entry",[13,14],"Biological: VRC-HIVDNA016-00-VP","Biological: VRC-DILUENT013-DIL-VP",{"label":16,"type":10,"description":17,"interventionNames":18},"1B","Participants will receive a higher dose of the adenovirus-vectored HIV vaccine or placebo at study entry",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"1C","Participants will receive the DNA plasmid vaccine or placebo at study entry and Days 28 and 56. They will also receive either a low dose of the adenovirus-vectored HIV vaccine or placebo at Day 168.",[13,23,14,24],"Biological: VRC-HIVADV014-00-VP","Biological: VRC-HIVADV014-00-VP placebo",{"label":26,"type":10,"description":27,"interventionNames":28},"1D","Participants will receive the DNA plasmid vaccine or placebo at study entry and Days 28 and 56. They will also receive either a higher dose of the adenovirus-vectored HIV vaccine or placebo at Day 168.",[13,23,14,24],{"label":30,"type":10,"description":31,"interventionNames":32},"2A","Participants will receive the DNA plasmid vaccine at study entry and Days 28 and 56. They will also receive a low dose of the adenovirus-vectored HIV vaccine at Day 168.",[13,23,14],{"label":34,"type":10,"description":35,"interventionNames":36},"2B","Participants will receive the DNA plasmid vaccine placebo at study entry and Days 28 and 56. They will also receive a the adenovirus-vectored HIV vaccine placebo at Day 168.",[14,24],[38,44,48,54],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"BIOLOGICAL","VRC-HIVDNA016-00-VP","1x10\\^11 per unit vaccine administered intramuscularly via Bioinjector",[9,16,20,26,30],null,{"type":39,"name":45,"description":46,"armGroupLabels":47,"otherNames":43},"VRC-HIVADV014-00-VP","4 mg administered intramuscularly via injection",[20,26,30],{"type":39,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"VRC-DILUENT013-DIL-VP","Administered intramuscularly via Bioinjector",[9,16,20,26,30,34],[53],"VRC-HIVDNA016-00-VP placebo",{"type":39,"name":55,"description":46,"armGroupLabels":56,"otherNames":43},"VRC-HIVADV014-00-VP placebo",[20,26,34],[58],{"name":59,"affiliation":60,"role":61},"Merlin Robb, MD","US Military HIV Research Program","STUDY_CHAIR",[63,75,85],{"facility":64,"status":43,"city":65,"state":43,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":43},"Kenya Med. Research Inst.\u002FWalter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho","Kericho","20200","Kenya","KE",{"type":70,"coordinates":71},"Point",[72,73],35.28314,-0.36774,{"lat":73,"lon":72},{"facility":76,"status":43,"city":77,"state":43,"zip":78,"country":79,"countryCode":43,"cosmosGeoPoint":80,"geoPoint":84,"contacts":43},"National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) CRS","Mbeya","025","Tanzania",{"type":70,"coordinates":81},[82,83],33.45,-8.9,{"lat":83,"lon":82},{"facility":86,"status":43,"city":87,"state":43,"zip":43,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":43},"Makerere University Walter Reed Project (MUWRP)","Kampala","Uganda","UG",{"type":70,"coordinates":91},[92,93],32.58219,0.31628,{"lat":93,"lon":92},{"type":96,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[98],{"name":99,"class":100},"United States Department of Defense","FED","100066996","phase-1-safety-of-and-immune-response-to-an-hiv-1-vaccine-vrc-hivdna016-00-vp-and-a-vaccine-booster-vrc-hivadv014-00-vp-in-hiv-uninfected-east-african-adults-100066996",false,"NCT00123968","Safety of and Immune Response to an HIV-1 Vaccine (VRC-HIVDNA016-00-VP) and a Vaccine Booster (VRC-HIVADV014-00-VP) in HIV Uninfected East African Adults","A Phase I\u002FII Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Boosted by a Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Adult Volunteers in East Africa","Inclusion Criteria:\n\n* Good general health\n* Willing to follow all the requirements of the study and available for follow-up for the duration of the study (14 to 16 months)\n* Able and willing to provide informed consent\n* Willing to undergo HIV testing and counseling and willing to receive HIV test results\n* Willing to not engage in high-risk behavior for HIV infection during the study\n* Willing to provide location and be visited at home\n* Willing to be identified with picture identification for study purposes\n* Willing to use acceptable forms of contraception\n* Pregnant women and those with conditions which render phlebotomy volumes hazardous will be allowed to participate using a minimized phlebotomy schedule\n\nExclusion Criteria:\n\n* HIV or HBV infection\n* HIV vaccines in prior HIV vaccine trial\n* Immunosuppressive or cytotoxic medications within the 6 months prior to study entry. Participants who have used corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for acute uncomplicated dermatitis are not excluded.\n* Blood products within 120 days prior to study entry\n* Immunoglobulin within 60 days prior to study entry\n* Live attenuated vaccines within 30 days prior to first study vaccine administration\n* Medically indicated subunit or killed vaccines or allergy treatment with antigen injections within 14 days prior to first study vaccine administration\n* Investigational research agents within 30 days prior to first study vaccine administration\n* Current tuberculosis prophylaxis or therapy\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* Serious adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain\n* Autoimmune disease or immunodeficiency\n* Unstable asthma or asthma requiring emergent or urgent care, hospitalization, intubation, or oral or intravenous corticosteroids during the 2 years prior to study entry\n* Diabetes mellitus type 1 or 2. Patients with gestational diabetes are not excluded.\n* Thyroid disease, including removal of thyroid or disease requiring medication within 3 years prior to study entry\n* Serious angioedema within 3 years prior to study entry or disease requiring medication within 2 years prior to study entry\n* Uncontrolled hypertension\n* Bleeding disorder\n* Active syphilis\n* Active cancer OR treated cancer that may recur during the duration of the study\n* Seizure disorder. Participants who have had fever-related seizures prior to age 2 are not excluded.\n* Absence of spleen OR partial or complete lack of splenic function\n* Psychiatric condition that may interfere with the study, including past or present psychoses, bipolar disorder, or suicidal attempts\n* Any medical, psychiatric, or social condition that, in the opinion of the investigator, may interfere with the study\n* Any occupational or other responsibility that, in the opinion of the investigator, may interfere with the study\n* Pregnancy, breastfeeding, or plan to become pregnant\n* Any occupational or other responsibility that, in the opinion of the investigator, may interfere with the study\n* Incapacitating illness precluding clinic visits\n* Unable to provide informed consent\n* Prisoners will not be enrolled while incarcerated and if enrolled prior to incarceration, will not be followed while in confinement. Re-consent will not be required upon release from prison.",true,"ALL","18 Years","50 Years",{"count":113,"type":114},326,"ACTUAL","INTERVENTIONAL",[117,118],"PHASE1","PHASE2","The purpose of the study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVDNA016-00-VP, and a vaccine booster, VRC-HIVADV014-00-VP, in HIV uninfected adults from Kenya, Tanzania, and Uganda.",[121],"HIV Infections",[123,124],"HIV Seronegativity","HIV Preventive Vaccine","COMPLETED","2021-11-04",{"date":128,"type":114},"2021-11-09",{"date":130,"type":43},"2006-05",{"date":132,"type":114},"2012-06",{"name":5,"class":6},3]