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Combination HIV Vaccine Regimen Demonstrates Modest Efficacy NEW YORK -- October 20, 2009 -- A combination of the ALVAC-HIV vaccine and the AIDSVAX B/E vaccine, appears to modestly reduce the risk of HIV infection among Thai heterosexuals at high-risk, according to final data from a phase 3 HIV vaccine study (RV144). The placebo-controlled trial tested the safety and effectiveness of the ALVAC-HIV vaccine (the primer dose), a modified canarypox vaccine developed by Sanofi Pasteur, and the AIDSVAX B/E vaccine (booster dose), a glycoprotein 120 vaccine developed by Vaxgen Inc. The vaccines are based on the subtype B and E HIV strains that commonly circulate in Thailand. The trial, conducted in the Rayong and Chon Buri provinces of Thailand, enrolled 16,402 healthy men and women aged 18 to 30 years old at various levels of risk for HIV infection. Participants received the ALVAC HIV vaccine or placebo at enrollment and again after 1 month, 3 months, and 6 months. The AIDSVAX B/E vaccine or placebo was given to participants at 3 and 6 months. Participants were tested for HIV infection every 6 months for 3 years. During each clinic visit, they were counselled on how to avoid becoming infected with HIV. 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% (P = .08). In the per-protocol analysis involving 12,452 subjects, the vaccine efficacy was 26.2% (P = .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% (P = .04). The vaccine regimen had no effect on the amount of virus in the blood of volunteers who acquired HIV infection during the study. Individuals who acquired HIV infection while participating in the Thai trial have been provided access to HIV care and treatment, including highly active antiretroviral therapy based on the guidelines of the Thai Ministry of Public Health. SOURCE: New England Journal of Medicine and National Institutes of Health E-mail this page to a friend or colleague! To print, use this version