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Randomized, Double-Blind Evaluation of Late Boost Strategies for HIV-Uninfected Vaccine Recipients in the RV144 HIV Vaccine Efficacy Trial.


ABSTRACT: The RV144 ALVAC-HIV prime, AIDSVAX B/E boost afforded 60% efficacy against human immunodeficiency virus (HIV) acquisition at 1 year, waning to 31.2% after 3.5 years. We hypothesized that additional vaccinations might augment immune correlates of protection.In a randomized placebo-controlled double-blind study of 162 HIV-negative RV144 vaccine recipients, we evaluated 2 additional boosts, given 6-8 years since RV144 vaccination, for safety and immunogenicity, at weeks 0 and 24. Study groups 1-3 received ALVAC-HIV+AIDSVAX B/E, AIDSVAX B/E, and ALVAC-HIV, respectively, or placebo.Vaccines were well tolerated. For groups 1 and 2, plasma immunoglobulin (Ig) G, IgA, and neutralizing antibody responses at week 2 were all significantly higher than 2 weeks after the last RV144 vaccination. IgG titers against glycoprotein (gp) 70V1V2 92TH023 increased 14-fold compared with 2 weeks after the last RV144 vaccination (14069 vs 999; P < .001). Groups 1 and 2 did not differ significantly from each other, whereas group 3 was similar to placebo recipients. Responses in groups 1 and 2 declined by week 24 but were boosted by the second vaccination, albeit at lower magnitude than for week 2.In RV144 vaccinees, AIDSVAX B/E with or without ALVAC-HIV 6-8 years after initial vaccination generated higher humoral responses than after RV144, but these responses were short-lived, and their magnitude did not increase with subsequent boost.NCT01435135.

SUBMITTER: Rerks-Ngarm S 

PROVIDER: S-EPMC5853427 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Randomized, Double-Blind Evaluation of Late Boost Strategies for HIV-Uninfected Vaccine Recipients in the RV144 HIV Vaccine Efficacy Trial.

Rerks-Ngarm Supachai S   Pitisuttithum Punnee P   Excler Jean-Louis JL   Nitayaphan Sorachai S   Kaewkungwal Jaranit J   Premsri Nakorn N   Kunasol Prayura P   Karasavvas Nicos N   Schuetz Alexandra A   Ngauy Viseth V   Sinangil Faruk F   Dawson Peter P   deCamp Allan C AC   Phogat Sanjay S   Garunathan Sanjay S   Tartaglia James J   DiazGranados Carlos C   Ratto-Kim Silvia S   Pegu Poonam P   Eller Michael M   Karnasuta Chitraporn C   Montefiori David C DC   Sawant Sheetal S   Vandergrift Nathan N   Wills Saintedym S   Tomaras Georgia D GD   Robb Merlin L ML   Michael Nelson L NL   Kim Jerome H JH   Vasan Sandhya S   O'Connell Robert J RJ  

The Journal of infectious diseases 20170401 8


<h4>Background</h4>The RV144 ALVAC-HIV prime, AIDSVAX B/E boost afforded 60% efficacy against human immunodeficiency virus (HIV) acquisition at 1 year, waning to 31.2% after 3.5 years. We hypothesized that additional vaccinations might augment immune correlates of protection.<h4>Methods</h4>In a randomized placebo-controlled double-blind study of 162 HIV-negative RV144 vaccine recipients, we evaluated 2 additional boosts, given 6-8 years since RV144 vaccination, for safety and immunogenicity, at  ...[more]

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