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J Infect Dis. 2017 Apr 15;215(8):1255-1263. doi: 10.1093/infdis/jix099.

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

Author information

1
Department of Disease Control, Ministry of Public Health, Nonthaburi.
2
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bankok
3
US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring.
4
Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda.
5
Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.
6
Global Solutions for Infectious Diseases, South San Francisco, California.
7
The Emmes Corporation, Rockville, Maryland.
8
Vaccine and Infectious Disease Division and Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington.
9
Sanofi Pasteur, Swiftwater, Pennsylvania.
10
Duke Human Vaccine Institute, Durham, North Carolina.
11
Department of Surgery, Duke University, Durham, North Carolina.

Abstract

Background:

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.

Methods:

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.

Results:

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.

Conclusions:

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.

Clinical Trials Registration:

NCT01435135.

KEYWORDS:

HIV; RV144; prime-boost.; vaccine

PMID:
28329190
PMCID:
PMC5853427
DOI:
10.1093/infdis/jix099
[Indexed for MEDLINE]
Free PMC Article

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