[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100093148":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":43,"centralContacts":34,"locations":48,"responsibleParty":116,"collaborators":118,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":34,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":34,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":146,"whyStopped":34,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,15,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","Participants in this group will receive an injection of the adenoviral vector vaccine VRC-HIVADV027-00VP at study entry and an injection of VRC-HIVADV038-00-VP at Month 3. There will be 9 study visits for this arm.",[13,14],"Biological: VRC-HIVADV027-00-VP","Biological: VRC-HIVADV038-00-VP",{"label":16,"type":10,"description":17,"interventionNames":18},"2","Participants in this group will receive an injection of VRC-HIVADV038-00-VP at study entry and an injection of VRC-HIVADV027-00-VP at Month 3. There will be 9 study visits for this group.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"3","Participants in this group will receive an injection of the VRC-HIVDNA044-00-VP vaccine at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV027-00-VPat Month 6. There will be 13 study visits for this group.",[13,23],"Biological: VRC-HIVDNA044-00-VP",{"label":25,"type":10,"description":26,"interventionNames":27},"4","Participants in this group will receive an injection of VRC-HIVDNA044-00-VP at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV038-00-VP at Month 6. There will be 13 study visits for this group.",[14,23],[29,35,39],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","VRC-HIVADV027-00-VP","Adenoviral vector booster vaccine",[9,16,20],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"VRC-HIVADV038-00-VP","Adenovirus vector booster vaccine",[9,16,25],{"type":30,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"VRC-HIVDNA044-00-VP","Experimental, multiclade, multigene HIV DNA vaccine",[20,25],[44],{"name":45,"affiliation":46,"role":47},"Jonathan Fuchs, MD, MPH","San Francisco Department of Public Health, University of California, San Francisco","STUDY_CHAIR",[49,62,72,81,87,96,106],{"facility":50,"status":34,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":34},"Alabama Vaccine CRS","Birmingham","Alabama","35294","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-86.80249,33.52066,{"lat":60,"lon":59},{"facility":63,"status":34,"city":64,"state":65,"zip":66,"country":54,"countryCode":55,"cosmosGeoPoint":67,"geoPoint":71,"contacts":34},"Bridge HIV CRS","San Francisco","California","94143",{"type":57,"coordinates":68},[69,70],-122.41942,37.77493,{"lat":70,"lon":69},{"facility":73,"status":34,"city":74,"state":74,"zip":75,"country":54,"countryCode":55,"cosmosGeoPoint":76,"geoPoint":80,"contacts":34},"Columbia P&S CRS","New York","10032-3732",{"type":57,"coordinates":77},[78,79],-74.00597,40.71427,{"lat":79,"lon":78},{"facility":82,"status":34,"city":74,"state":74,"zip":83,"country":54,"countryCode":55,"cosmosGeoPoint":84,"geoPoint":86,"contacts":34},"New York Blood Center CRS","10065",{"type":57,"coordinates":85},[78,79],{"lat":79,"lon":78},{"facility":88,"status":34,"city":89,"state":74,"zip":90,"country":54,"countryCode":55,"cosmosGeoPoint":91,"geoPoint":95,"contacts":34},"University of Rochester Vaccines to Prevent HIV Infection CRS","Rochester","14642",{"type":57,"coordinates":92},[93,94],-77.61556,43.15478,{"lat":94,"lon":93},{"facility":97,"status":34,"city":98,"state":99,"zip":100,"country":54,"countryCode":55,"cosmosGeoPoint":101,"geoPoint":105,"contacts":34},"Vanderbilt Vaccine (VV) CRS","Nashville","Tennessee","37232-2582",{"type":57,"coordinates":102},[103,104],-86.78444,36.16589,{"lat":104,"lon":103},{"facility":107,"status":34,"city":108,"state":109,"zip":110,"country":54,"countryCode":55,"cosmosGeoPoint":111,"geoPoint":115,"contacts":34},"Seattle Vaccine and Prevention CRS","Seattle","Washington","98109-1024",{"type":57,"coordinates":112},[113,114],-122.33207,47.60621,{"lat":114,"lon":113},{"type":117,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[119],{"name":120,"class":121},"HIV Vaccine Trials Network","NETWORK","100093148","phase-1-safety-of-and-immune-response-to-a-dna-hiv-vaccine-followed-by-boosting-with-one-of-two-serotypes-of-adenoviral-vector-hiv-vaccine-in-healthy-adults-100093148",false,"NCT00472719","Safety of and Immune Response to a DNA HIV Vaccine Followed By Boosting With One of Two Serotypes of Adenoviral Vector HIV Vaccine in Healthy Adults","A Phase 1B Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenoviral Serotype 35 (rAd35) and Serotype 5 (rAd5) HIV-1 Vaccines When Given in Heterologous Prime-Boost Regimens or as a Boost to a Recombinant DNA Vaccine in Healthy, HIV-1-Uninfected Adult Participants With Pre-Existing Immunity to Adenovirus Serotype 5 Infection","Inclusion Criteria:\n\n* HIV-1 and -2 uninfected\n* Have access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study\n* Willing to receive HIV test results\n* Good general health\n* Pre-existing adenovirus 5 (Ad5) neutralizing antibody titer of 1:1000 ratio or greater\n* Willing to use acceptable forms of contraception from at least 21 days prior to enrollment through the duration of the study\n\nExclusion Criteria:\n\n* HIV vaccines in prior HIV vaccine trial\n* Immunosuppressive medications within 168 days prior to first study vaccine administration\n* Blood products within 120 days prior to first study vaccine administration\n* Immunoglobulin within 60 days prior to first study vaccine administration\n* Live attenuated vaccines within 30 days prior to first study vaccine administration\n* Investigational research agents within 30 days prior to first study vaccine administration\n* Subunit or killed vaccines within 14 days prior to first study vaccine administration\n* Current anti-tuberculosis prophylaxis or therapy\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 social condition that would interfere with the study.\n* Serious adverse reaction to vaccines. Participants who have had an adverse reaction to pertussis vaccine as a child are not excluded.\n* Autoimmune disease or immunodeficiency\n* Active syphilis infection. Participants with fully treated syphilis at least 6 months prior to study entry are not excluded.\n* Unstable asthma. More information about this criterion can be found in the protocol.\n* Diabetes mellitus type 1 or 2. Participants with a history of isolated gestational diabetes are not excluded.\n* Absence of thyroid or thyroid disease requiring treatment\n* Serious angioedema within the past 3 years or requiring medication within 2 years of study entry\n* Body mass index (BMI) of 40 or less OR BMI of 35 or less if certain other criteria apply. More information about these criteria can be found in the protocol.\n* Uncontrolled hypertension\n* Bleeding disorder\n* Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.\n* Seizure disorder\n* Absence of spleen\n* Certain abnormal laboratory values\n* Mental illness that would interfere with compliance with the protocol\n* Other conditions that, in the judgment of the investigator, would interfere with the study\n* Pregnant or breastfeeding",true,"ALL","18 Years","50 Years",{"count":134,"type":135},17,"ACTUAL","INTERVENTIONAL",[138],"PHASE1","The purpose of this study is to determine the safety of and immune response to an experimental DNA HIV vaccine followed by boosting with either an experimental adenoviral vector HIV vaccine of serotype 5 or 35 in HIV uninfected adults. This study will also determine the safety of and immune response to an adenoviral vector HIV vaccine of serotype 5 followed by a booster of an adenoviral vector of serotype 35, or vice versa, in HIV uninfected adults.",[141],"HIV Infections",[143,144,145],"HIV Seronegativity","HIV Preventive Vaccine","Adenovirus","COMPLETED","2021-10-13",{"date":149,"type":135},"2021-10-14",{"date":151,"type":34},"2007-08",{"date":153,"type":135},"2013-01",{"name":5,"class":6},7]