Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults

Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.

Timeline

Start

2018-03-16

Primary completion

2020-05-11

Completion

2020-10-22

Publications

• Jamieson PJ, Shen X, Abu-Shmais AA, Wasdin PT, Janowska K, Edwards RJ, Scapellato G, Bukenya M, Bass LE, Richardson SI, Manamela NP, Liu S, Barr M, Adams L, Paola Velez-Castro C, McCarthy C, Alexander CA, Gillespie RA, Mimms J, Suryadevara N, Sornberger TA, Zost SJ, Parks R, Flaherty S, Janke AK, Howard BN, Suresh YP, Ruprecht RM, Crowe JE Jr, Carnahan RH, Bailey JR, Kanekiyo M, Lingwood D, Haynes BF, Moore PL, Bonami RH, Tomaras GD, Archarya P, Montefiori DC, Kalams SA, Lu S, Georgiev IS. Glycan-reactive antibodies isolated from human HIV-1 vaccine trial participants show broad pathogen cross-reactivity. J Virol. 2025 Dec 23;99(12):e0125625. doi: 10.1128/jvi.01256-25. Epub 2025 Nov 10.
• 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.
• Frank I, Li SS, Grunenberg N, Overton ET, Robinson ST, Zheng H, Seaton KE, Heptinstall JR, Allen MA, Mayer KH, Culver DA, Keefer MC, Edupuganti S, Pensiero MN, Mehra VL, De Rosa SC, Morris DE, Wang S, Seaman MS, Montefiori DC, Ferrari G, Tomaras GD, Kublin JG, Corey L, Lu S; HVTN 124 Study Team. Safety and immunogenicity of a polyvalent DNA-protein HIV vaccine with matched Env immunogens delivered as a prime-boost regimen or coadministered in HIV-uninfected adults in the USA (HVTN 124): a phase 1, placebo-controlled, double-blind randomised controlled trial. Lancet HIV. 2024 May;11(5):e285-e299. doi: 10.1016/S2352-3018(24)00036-5.

Drugs

Indications