Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults

Summary

This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.

Timeline

Start

2016-12-07

Primary completion

2019-08-07

Completion

2020-02-12

Publications

• Conley HE, Oh SY, Garrett N, Kublin J, Monaco CL, Watts S, Jha S, Ferrari G, Tomaras GD, Geraghty DE, Chan C, Pollara J. IgG and Fc Receptor Genetic Variation Associates With Functional Antibody Responses in a DNA and Protein Candidate HIV Vaccine Trial. J Acquir Immune Defic Syndr. 2025 Dec 1;100(4):371-375. doi: 10.1097/QAI.0000000000003734.
• 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.
• Garrett N, Dintwe O, Monaco CL, Jones M, Seaton KE, Church EC, Grunenberg N, Hutter J, deCamp A, Huang Y, Lu H, Mann P, Robinson ST, Heptinstall J, Jensen RL, Pantaleo G, Ding S, Koutsoukos M, Hosseinipour MC, Van Der Meeren O, Gilbert PB, Ferrari G, Andersen-Nissen E, McElrath MJ, Tomaras GD, Gray GE, Corey L, Kublin JG; HVTN 108 and HVTN 111 Study Teams. Safety and Immunogenicity of a DNA Vaccine With Subtype C gp120 Protein Adjuvanted With MF59 or AS01B: A Phase 1/2a HIV-1 Vaccine Trial. J Acquir Immune Defic Syndr. 2024 Aug 1;96(4):350-360. doi: 10.1097/QAI.0000000000003438. Epub 2024 Jun 21.
• 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.
• Mngadi KT, Maharaj B, Duki Y, Grove D, Andriesen J. Using Mobile Technology (pMOTAR) to Assess Reactogenicity: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 3;7(10):e175. doi: 10.2196/resprot.9396.

Drugs

Indications