drugset / Trial / NCT01095224
Evaluating Heterologous-Insert Prime-Boost HIV Vaccine Regimens in HIV-Uninfected Adults
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to evaluate the safety and immune response of an adenovirus-based HIV-1 vaccine regimen that includes two vaccines given at different time points in HIV-uninfected adults.
Timeline
- Start
- 2010-09
- Primary completion
- 2012-10
- Completion
- 2016-02
Publications
- Background Vaine M, Lu S, Wang S. Progress on the induction of neutralizing antibodies against HIV type 1 (HIV-1). BioDrugs. 2009;23(3):137-53. doi: 10.2165/00063030-200923030-00001.
- Background Appay V, Douek DC, Price DA. CD8+ T cell efficacy in vaccination and disease. Nat Med. 2008 Jun;14(6):623-8. doi: 10.1038/nm.f.1774.
- Walsh SR, Moodie Z, Fiore-Gartland AJ, Morgan C, Wilck MB, Hammer SM, Buchbinder SP, Kalams SA, Goepfert PA, Mulligan MJ, Keefer MC, Baden LR, Swann EM, Grant S, Ahmed H, Li F, Hertz T, Self SG, Friedrich D, Frahm N, Liao HX, Montefiori DC, Tomaras GD, McElrath MJ, Hural J, Graham BS, Jin X; HVTN 083 Study Group and the NIAID HVTN. Vaccination With Heterologous HIV-1 Envelope Sequences and Heterologous Adenovirus Vectors Increases T-Cell Responses to Conserved Regions: HVTN 083. J Infect Dis. 2016 Feb 15;213(4):541-50. doi: 10.1093/infdis/jiv496. Epub 2015 Oct 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rAd35 Env A | Vaccine | 1e+10 unknown | Intramuscular |
| Subject | rAd5 Env A | Vaccine | 1e+10 unknown | Intramuscular |
| Subject | rAd5 Env B | Vaccine | 1e+10 unknown | Intramuscular |