A Safety and Immune Response Study of 2 Experimental HIV Vaccines

Summary

The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination. HIV is the virus that causes AIDS. 252 people are taking part in this study at multiple sites. The US National Institutes of Health (NIH) is paying for the study. The investigators are doing this study to answer several questions. * Are the study vaccines safe to give to people? * Are people able to take the study vaccines without becoming too uncomfortable? * How do people's immune systems respond to the study vaccines? (Your immune system protects you from disease.)

Timeline

Start

2015-02-02

Primary completion

2018-08-07

Completion

2018-08-07

Publications

• Moodie Z, Li SS, Giorgi EE, Williams LD, Dintwe O, Carpp LN, Chen S, Seaton KE, Sawant SS, Zhang L, Heptinstall J, Liu S, Grunenberg N, Tomaka F, Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Ake JA, Vasan S, Pantaleo G, Frank I, Baden LR, Goepfert PA, Keefer M, Chirenje M, Hosseinipour MC, Mngadi K, Laher F, Garrett N, Bekker LG, De Rosa S, Andersen-Nissen E, Kublin JG, Lu S, Gilbert PB, Gray GE, Corey L, McElrath MJ, Tomaras GD. A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials. Emerg Microbes Infect. 2025 Dec;14(1):2485317. doi: 10.1080/22221751.2025.2485317. Epub 2025 Apr 7.
• Naicker V, Laher F, Bekker LG, Seaton KE, Allen M, De Rosa S, Yates NL, Mkhize NN, Saunders K, Heptinstall J, Malahleha M, Mngadi K, Daniels B, Innes C, Yu C, Modise T, Bekker V, Grunenberg N, Furch B, Miner MD, Phogat S, Diazgranados CA, Gurunathan S, Koutsoukos M, Van Der Meeren O, Roxby AC, Ferrari G, Morris L, Montefiori D, McElrath MJ, Tomaras GD, Moodie Z. Safety and immunogenicity after a 30-month boost of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120/MF59 vaccine boost (HVTN 100): A phase 1-2 randomized double-blind placebo-controlled trial. PLOS Glob Public Health. 2024 Sep 20;4(9):e0003319. doi: 10.1371/journal.pgph.0003319. eCollection 2024.
• Hanass-Hancock J, Carpenter B, Reddy T, Nzuza A, Gaffoor Z, Goga A, Andrasik M. Participants' characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa. Trials. 2021 Dec 11;22(1):897. doi: 10.1186/s13063-021-05792-7.
• Laher F, Moodie Z, Cohen KW, Grunenberg N, Bekker LG, Allen M, Frahm N, Yates NL, Morris L, Malahleha M, Mngadi K, Daniels B, Innes C, Saunders K, Grant S, Yu C, Gilbert PB, Phogat S, DiazGranados CA, Koutsoukos M, Van Der Meeren O, Bentley C, Mkhize NN, Pensiero MN, Mehra VL, Kublin JG, Corey L, Montefiori DC, Gray GE, McElrath MJ, Tomaras GD. Safety and immune responses after a 12-month booster in healthy HIV-uninfected adults in HVTN 100 in South Africa: A randomized double-blind placebo-controlled trial of ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines. PLoS Med. 2020 Feb 24;17(2):e1003038. doi: 10.1371/journal.pmed.1003038. eCollection 2020 Feb.
• Zhao LP, Fiore-Gartland A, Carpp LN, Cohen KW, Rouphael N, Fleurs L, Dintwe O, Zhao M, Moodie Z, Fong Y, Garrett N, Huang Y, Innes C, Janes HE, Lazarus E, Michael NL, Nitayaphan S, Pitisuttithum P, Rerks-Ngarm S, Robb ML, De Rosa SC, Corey L, Gray GE, Seaton KE, Yates NL, McElrath MJ, Frahm N, Tomaras GD, Gilbert PB. Landscapes of binding antibody and T-cell responses to pox-protein HIV vaccines in Thais and South Africans. PLoS One. 2020 Jan 30;15(1):e0226803. doi: 10.1371/journal.pone.0226803. eCollection 2020.
• Bekker LG, Moodie Z, Grunenberg N, Laher F, Tomaras GD, Cohen KW, Allen M, Malahleha M, Mngadi K, Daniels B, Innes C, Bentley C, Frahm N, Morris DE, Morris L, Mkhize NN, Montefiori DC, Sarzotti-Kelsoe M, Grant S, Yu C, Mehra VL, Pensiero MN, Phogat S, DiazGranados CA, Barnett SW, Kanesa-Thasan N, Koutsoukos M, Michael NL, Robb ML, Kublin JG, Gilbert PB, Corey L, Gray GE, McElrath MJ; HVTN 100 Protocol Team. Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial. Lancet HIV. 2018 Jul;5(7):e366-e378. doi: 10.1016/S2352-3018(18)30071-7. Epub 2018 Jun 18.

Drugs

Indications