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1 March 2005

Volume 191, Number 5
The Journal of Infectious Diseases 2005;191:654–665
© 2005 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2005/19105-0003$15.00
DOI: 10.1086/428404
MAJOR ARTICLE

Placebo‐Controlled Phase 3 Trial of a Recombinant Glycoprotein 120 Vaccine to Prevent HIV‐1 Infection

The rgp120 HIV Vaccine Study Groupa

Background.A vaccine is needed to prevent human immunodeficiency virus type 1 (HIV‐1) infection.

Methods.A double‐blind, randomized trial of a recombinant HIV‐1 envelope glycoprotein subunit (rgp120) vaccine was conducted among men who have sex with men and among women at high risk for heterosexual transmission of HIV‐1. Volunteers received 7 injections of either vaccine or placebo (ratio, 2:1) over 30 months. The primary end point was HIV‐1 seroconversion over 36 months.

Results.A total of 5403 volunteers (5095 men and 308 women) were evaluated. The vaccine did not prevent HIV‐1 acquisition: infection rates were 6.7% in 3598 vaccinees and 7.0% in 1805 placebo recipients; vaccine efficacy (VE) was estimated as 6% (95% confidence interval, −17% to 24%). There were no significant differences in viral loads, rates of antiretroviral‐therapy initiation, or the genetic characteristics of the infecting HIV‐1 strains between treatment arms. Exploratory subgroup analyses showed nonsignificant trends toward efficacy in preventing infection in the highest risk (VE, 43%; ) and nonwhite (VE, 47%; ) volunteers ( , adjusted for multiple subgroup comparisons).

Conclusions.There was no overall protective effect. The efficacy trends in subgroups may provide clues for the development of effective immunization approaches.

Received 13 July 2004; accepted 15 November 2004; electronically published 27 January 2005.

Reprints or correspondence: Dr. Marc Gurwith, VaxGen, 1000 Marina Blvd., Ste. 200, Brisbane, CA 94005‐1841 ().

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Online publication date: 1-Feb-2005.
CrossRef

  • Presented in part: 43rd Annual Interscience Meeting on Antimicrobial Agents and Chemotherapy, Chicago, 14–17 September 2003 (abstract H‐1942); AIDS Vaccine 2003, New York, September 18–21 (abstract 148).

    Financial support: VaxGen; Centers for Disease Control and Prevention; National Institutes of Health; Science Applications International Corporation–Frederick (contract 23XS119).

    Potential conflicts of interest: listed after the text with the members of the Writing and Analysis Committee.

  • Study group members and members of the Writing and Analysis Committee are listed after the text.

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