Safety and Immune Response to a Clade C DNA HIV Vaccine

Summary

The purpose of this study is to evaluate the safety and immune response to an HIV clade C DNA vaccine and to an MF59-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.

Timeline

Start

2016-06-21

Primary completion

2018-07-11

Completion

2018-07-11

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.
• 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.
• Hosseinipour MC, Innes C, Naidoo S, Mann P, Hutter J, Ramjee G, Sebe M, Maganga L, Herce ME, deCamp AC, Marshall K, Dintwe O, Andersen-Nissen E, Tomaras GD, Mkhize N, Morris L, Jensen R, Miner MD, Pantaleo G, Ding S, Van Der Meeren O, Barnett SW, McElrath MJ, Corey L, Kublin JG; HVTN 111 Protocol Team. Phase 1 Human Immunodeficiency Virus (HIV) Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Subtype C DNA and MF59-Adjuvanted Subtype C Envelope Protein. Clin Infect Dis. 2021 Jan 23;72(1):50-60. doi: 10.1093/cid/ciz1239.

Drugs

Indications