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

by Fatima Laher, Zoe Moodie, Kristen W. Cohen, Nicole Grunenberg, Linda-Gail Bekker, Mary Allen, Nicole Frahm, Nicole L. Yates, Lynn Morris, Mookho Malahleha, Kathryn Mngadi, Brodie Daniels, Craig Innes, Kevin Saunders, Shannon Grant, Chenchen Yu, Peter B. Gilbert, Sanjay Phogat, Carlos A. DiazGranados, Marguerite Koutsoukos, Olivier Van Der Meeren, Carter Bentley, Nonhlanhla N. Mkhize, Michael N. Pensiero, Vijay L. Mehra, James G. Kublin, Lawrence Corey, David C. Montefiori, Glenda E. Gray, M. Juliana McElrath, Georgia D. Tomaras BackgroundHVTN 100 evaluated the safety and immunogenicity of an HIV subtype C pox-protein vaccine regimen, investigating a 12-month booster to extend vaccine-induced immune responses. Methods and findingsA phase 1 –2 randomized double-blind placebo-controlled trial enrolled 252 participants (210 vaccine/42 placebo; median age 23 years; 43% female) between 9 February 2015 and 26 May 2015. Vaccine recipients received ALVAC-HIV (vCP2438) alone at months 0 and 1 and with bivalent subtype C gp120/MF59 at months 3, 6, and 12. Antibody (IgG, IgG3 binding, and neutralizing) and CD4+ T-cell (expressing interferon-gamma, interleukin-2, and CD40 ligand) responses were evaluated at month 6.5 for all participants and at months 12, 12.5, and 18 for a randomly selected subset. The primary analysis compared IgG bindi ng antibody (bAb) responses and CD4+ T-cell responses to 3 vaccine-matched antigens at peak (month 6.5 versus 12.5) and durability (month 12 versus...
Source: PLoS Medicine - Category: Internal Medicine Authors: Source Type: research