Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants

Summary

A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants

Timeline

Start

2018-01-16

Primary completion

2020-07-30

Completion

2020-07-30

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.
• Chirenje ZM, Laher F, Dintwe O, Muyoyeta M, deCamp AC, He Z, Grunenberg N, Laher Omar F, Seaton KE, Polakowski L, Woodward Davis AS, Maganga L, Baden LR, Mayer K, Kalams S, Keefer M, Edupuganti S, Rodriguez B, Frank I, Scott H, Stranix-Chibanda L, Gurunathan S, Koutsoukos M, Van Der Meeren O, DiazGranados CA, Paez C, Andersen-Nissen E, Kublin J, Corey L, Ferrari G, Tomaras G, McElrath MJ. Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120. J Infect Dis. 2024 Aug 16;230(2):e405-e415. doi: 10.1093/infdis/jiad434.

Drugs

Indications