[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100095050":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":28,"locations":28,"responsibleParty":46,"collaborators":48,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":28,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":28,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":85,"whyStopped":28,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":28,"completionDateStruct":28,"leadSponsor":89,"locationsCount":28},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","Participants will receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP. Injections will occur at study entry and Weeks 4, 8, and 24.",[13,14],"Biological: VRC-HIVDNA016-00-VP","Biological: VRC-HIVADV014-00-VP",{"label":16,"type":17,"description":18,"interventionNames":19},"2","PLACEBO_COMPARATOR","Participants will receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP placebo followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP placebo. Injections will occur at study entry and Weeks 4, 8, and 24.",[20,21],"Biological: VRC-HIVDNA016-00-VP placebo","Biological: VRC-HIVADV014-00-VP placebo",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","VRC-HIVDNA016-00-VP","DNA vaccine administered intramuscularly",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"VRC-HIVADV014-00-VP","Adenovirus vaccine administered intramuscularly",[9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"VRC-HIVDNA016-00-VP placebo","DNA vaccine placebo administered intramuscularly",[16],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"VRC-HIVADV014-00-VP placebo","Adenovirus vaccine placebo administered intramuscularly",[16],[42],{"name":43,"affiliation":44,"role":45},"Scott M. Hammer, MD","Columbia University","STUDY_CHAIR",{"type":47,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[49,52,55,57,59],{"name":50,"class":51},"Centers for Disease Control and Prevention","FED",{"name":53,"class":54},"HIV Vaccine Trials Network","NETWORK",{"name":56,"class":54},"International AIDS Vaccine Initiative",{"name":58,"class":54},"US Military HIV Research Program",{"name":60,"class":61},"Vaccine Research Center","UNKNOWN","100095050","phase-2-safety-and-effectiveness-of-an-hiv-dna-vaccine-followed-by-an-hiv-adenoviral-vector-vaccine-for-prevention-of-hiv-infection-in-the-americas-and-africa-100095050",false,"NCT00498056","Safety and Effectiveness of an HIV DNA Vaccine Followed by an HIV Adenoviral Vector Vaccine for Prevention of HIV Infection in the Americas and Africa","A Phase IIB Test-of-Concept, Randomized, Double-Blind, Placebo-Controlled, International Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Persons","Inclusion Criteria:\n\n* At risk for HIV-1 sexual exposure within 24 weeks prior to study entry. More information about this criterion is available in the protocol.\n* HIV uninfected within 6 weeks prior to study entry\n* Willing to undergo HIV testing and counseling\n* Willing to receive HIV test results\n* Willing to use highly reliable method for contraception for at least the first 6 months of study\n\nExclusion Criteria:\n\n* Participation in a clinical trial of another investigational product within 12 weeks prior to study entry\n* Contraindication to intramuscular injections, history of bleeding disorder, or use of anticoagulant therapy in the 4 weeks prior to study entry\n* Previously received an investigational HIV vaccine\n* History of severe local or systemic reactogenicity to vaccines or severe allergic reactions or recurrent rash for unknown reasons in the 5 years prior to study entry\n* Received an inactivated vaccine within the 2 weeks prior to study entry or of live attenuated within 4 weeks of study entry\n* Received any blood products or any immunomodulatory agents within 12 weeks of study entry\n* History of cancer. Participants with a history of localized squamous cell or basal cell carcinoma of the skin are not excluded.\n* History of clinically significant autoimmune disease or immune deficiency syndrome\n* Use of immunosuppressive medications within 24 weeks of study entry. Participants who have completed a short course of steroids more than 2 weeks prior to study entry, or using inhaled or topical steroids are not excluded.\n* Seizure disorder. Participants who have had seizures with fever under the age of 2, seizures secondary to alcohol withdrawal more than 3 years prior to study entry, or a singular seizure more than 3 years ago that has not recurred or required treatment within the last 3 years are not excluded.\n* Any medical condition or acute medical illness that, in the opinion of the investigator, would interfere with the study\n* Pregnancy, plan to become pregnant, or breastfeeding",true,"ALL","18 Years","45 Years",{"count":74,"type":75},0,"ACTUAL","INTERVENTIONAL",[78],"PHASE2","The development of a safe and effective vaccine is the best strategy for preventing the spread of HIV-1. The purpose of this study is to determine the safety and effectiveness of and immune responses to an HIV vaccine regimen in healthy adults at risk for HIV infection.",[81],"HIV Infections",[83,84],"HIV Seronegativity","HIV Preventive Vaccine","WITHDRAWN","2021-10-28",{"date":88,"type":75},"2021-11-01",{"name":5,"class":6}]