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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 per-protocol 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. (ClinicalTrials.gov number, NCT00223080
[ClinicalTrials.gov]
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Source Information
From the Department of Disease Control, Ministry of Public Health, Nonthaburi (S.R.-N., R.P., C.N., S.C., C.K., P.T., P.K.); Vaccine Trials Center (P.P.) and Data Management Unit (J.K.), Faculty of Tropical Medicine, Mahidol University, Bangkok; Thai Component (S.N.) and U.S. Army Medical Component (J.C., R.P., M.S., M.B.), Armed Forces Research Institute of Medical Sciences, Bangkok — all in Thailand; the Division of AIDS, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (E.A.); Sanofi Pasteur, Swiftwater, PA (S.G., J.T., J.G.M.); Global Solutions for Infectious Diseases, South San Francisco, CA (D.P.F.); the Emmes Corporation, Rockville, MD (D.S.); the Global AIDS Program, Centers for Disease Control and Prevention, Atlanta (D.L.B.); U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Rockville, MD (M.L.R., N.L.M., J.H.K.); and U.S. Army Medical Materiel Development Activity, Ft. Detrick, MD (J.H.K.).
This article (10.1056/NEJMoa0908492) was published on October 20, 2009, and was last updated on November 19, 2009, at NEJM.org.
Address reprint requests to Dr. Kim at the U.S. Military HIV Research Program, Walter Reed Army Institute of Research, 1600 E. Gude Dr., Rockville, MD 20850, or at jkim{at}hivresearch.org.
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