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Title: Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand
Authors: Supachai Rerks-Ngarm
Punnee Pitisuttithum
Sorachai Nitayaphan
Jaranit Kaewkungwal
Joseph Chiu
Robert Paris
Nakorn Premsri
Chawetsan Namwat
Mark De Souza
Elizabeth Adams
Michael Benenson
Sanjay Gurunathan
Jim Tartaglia
John G. McNeil
Donald P. Francis
Donald Stablein
Deborah L. Birx
Supamit Chunsuttiwat
Chirasak Khamboonruang
Prasert Thongcharoen
Merlin L. Robb
Nelson L. Michael
Prayura Kunasol
Jerome H. Kim
Thailand Ministry of Public Health
Mahidol University
Armed Forces Research Institute of Medical Sciences, Thailand
National Institute of Allergy and Infectious Diseases
Sanofi Pasteur
Global Solutions for Infectious Diseases
The EMMES Corporation
Centers for Disease Control and Prevention
Walter Reed Army Institute of Research
US Army Medical Materiel Development Activity
Keywords: Medicine
Issue Date: 3-Dec-2009
Citation: New England Journal of Medicine. Vol.361, No.23 (2009), 2209-2220
Abstract: BACKGROUND: The development of a safe and effective vaccine against the human immunodeficiency virus type 1 (HIV-1) is critical to pandemic control. METHODS: In a community-based, randomized, multicenter, double-blind, placebo-controlled efficacy trial, we evaluated four priming injections of a recombinant canarypox vector vaccine (ALVAC-HIV [vCP1521]) plus two booster injections of a recombinant glycoprotein 120 subunit vaccine (AIDSVAX B/E). The vaccine and placebo injections were administered to 16,402 healthy men and women between the ages of 18 and 30 years in Rayong and Chon Buri provinces in Thailand. The volunteers, primarily at heterosexual risk for HIV infection, were monitored for the coprimary end points: HIV-1 infection and early HIV-1 viremia, at the end of the 6-month vaccination series and every 6 months thereafter for 3 years. RESULTS: In the intention-to-treat analysis involving 16,402 subjects, there was a trend toward the prevention of HIV-1 infection among the vaccine recipients, with a vaccine efficacy of 26.4% (95% confidence interval [CI], -4.0 to 47.9; P = 0.08). In the perprotocol analysis involving 12,542 subjects, the vaccine efficacy was 26.2% (95% CI, -13.3 to 51.9; P = 0.16). In the modified intention-to-treat analysis involving 16,395 subjects (with the exclusion of 7 subjects who were found to have had HIV-1 infection at baseline), the vaccine efficacy was 31.2% (95% CI, 1.1 to 52.1; P = 0.04). Vaccination did not affect the degree of viremia or the CD4+ T-cell count in subjects in whom HIV-1 infection was subsequently diagnosed. CONCLUSIONS: This ALVAC-HIV and AIDSVAX B/E vaccine regimen may reduce the risk of HIV infection in a community-based population with largely heterosexual risk. Vaccination did not affect the viral load or CD4+ count in subjects with HIV infection. Although the results show only a modest benefit, they offer insight for future research. ( number, NCT00223080.). Copyright © 2009 Massachusetts Medical Society.
ISSN: 15334406
Appears in Collections:Scopus 2006-2010

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