biostudies-literatureBaden LRNCATS NIH HHSNIAID NIH HHS313-22https://www.ebi.ac.uk/biostudies/studies/S-EPMC5034222biostudies-literatureUnknown164(5)<h4>Background</h4>A prophylactic HIV-1 vaccine is a global health priority.<h4>Objective</h4>To assess a novel vaccine platform as a prophylactic HIV-1 regimen.<h4>Design</h4>Randomized, double-blind, placebo-controlled trial. Both participants and study personnel were blinded to treatment allocation. (ClinicalTrials.gov: NCT01215149).<h4>Setting</h4>United States, East Africa, and South Africa.<h4>Patients</h4>Healthy adults without HIV infection.<h4>Intervention</h4>2 HIV-1 vaccines (adenovirus serotype 26 with an HIV-1 envelope A insert [Ad26.EnvA] and adenovirus serotype 35 with an HIV-1 envelope A insert [Ad35.Env], both administered at a dose of 5 × 1010 viral particles) in homologous and heterologous combinations.<h4>Measurements</h4>Safety and immunogenicity and the effect of baseAnnals of internal medicineAssessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention: A Randomized Trial.PMC5034222UM1 AI069412UM1 AI068614U19 AI066305UM1 AI068618UL1 TR000170UM1 AI069453Hayes PSwann EInnes CPage-Shipp LGrazia-Pau MKarita EPeter LAnzala ODolin RSadoff JLaher FLaufer DSB003-IPCAVD004-HVTN091 Study GroupSeaman MSGilmour JWalsh SRMcElrath MJMutua GCohen YZBarouch DHBaden LRWeijtens MGrunenberg NFrahm NFast PLombardo ANyombayire JCox JRoux SGray GMcElrath MDally LBekker LGfalseAssessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention: A Randomized Trial.<h4>Background</h4>A prophylactic HIV-1 vaccine is a global health priority.<h4>Objective</h4>To assess a novel vaccine platform as a prophylactic HIV-1 regimen.<h4>Design</h4>Randomized, double-blind, placebo-controlled trial. Both participants and study personnel were blinded to treatment allocation. (ClinicalTrials.gov: NCT01215149).<h4>Setting</h4>United States, East Africa, and South Africa.<h4>Patients</h4>Healthy adults without HIV infection.<h4>Intervention</h4>2 HIV-1 vaccines (adenovirus serotype 26 with an HIV-1 envelope A insert [Ad26.EnvA] and adenovirus serotype 35 with an HIV-1 envelope A insert [Ad35.Env], both administered at a dose of 5 × 1010 viral particles) in homologous and heterologous combinations.<h4>Measurements</h4>Safety and immunogenicity and the effect of base2016-01-01T00:00:00Z2016 Mar2026-05-01T18:04:46.003Z2026-04-07T17:10:03.701ZS-EPMC50342222683333610.7326/M15-088010.7326/m15-0880