Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults

Phase 1 Completed 218 enrolled International AIDS Vaccine Initiative Beth Israel Deaconess Medical Center · collab HIV Vaccine Trials Network · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab Ragon Institute of MGH, MIT and Harvard · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and homologous prime-boost regimens at different time intervals.

Timeline

Start: 2010-10
Primary completion: 2012-12
Completion: 2012-12

Publications

Baden LR, Karita E, Mutua G, Bekker LG, Gray G, Page-Shipp L, Walsh SR, Nyombayire J, Anzala O, Roux S, Laher F, Innes C, Seaman MS, Cohen YZ, Peter L, Frahm N, McElrath MJ, Hayes P, Swann E, Grunenberg N, Grazia-Pau M, Weijtens M, Sadoff J, Dally L, Lombardo A, Gilmour J, Cox J, Dolin R, Fast P, Barouch DH, Laufer DS; B003-IPCAVD004-HVTN091 Study Group. Assessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention: A Randomized Trial. Ann Intern Med. 2016 Mar 1;164(5):313-22. doi: 10.7326/M15-0880. Epub 2016 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ad26.ENVA.01	Vaccine	5e+10 unknown	Intramuscular
Subject	Ad35-ENV	Vaccine	5e+10 unknown	Intramuscular

Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults

Summary

Timeline

Publications

Drugs

Indications