Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection

N. M. Flynn, D. N. Forthal, C. D. Harro, F. N. Judson, K. H. Mayer, M. F. Para, Marc Gurwith

Research output: Contribution to journalArticlepeer-review

Abstract

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%; n = 247) and nonwhite (VE, 47%; n = 914) volunteers (P = .10, 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.

Original languageEnglish (US)
Pages (from-to)654-665
Number of pages12
JournalJournal of Infectious Diseases
Volume191
Issue number5
DOIs
StatePublished - Mar 1 2005

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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