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

摘要: Background A vaccine is needed to prevent human immunodeficiency virus type 1 (HIV-1) infection. Methods double-blind, randomized trial of a recombinant HIV-1 envelope glycoprotein subunit (rgp120) was conducted among men who have sex with and women at high risk for heterosexual transmission HIV-1. Volunteers received 7 injections either or placebo (ratio, 2 : 1) over 30 months. The primary end point seroconversion 36 Results total 5403 volunteers (5095 308 women) were evaluated. did not acquisition: infection rates 6.7% in 3598 vaccinees 7.0% 1805 recipients; efficacy (VE) estimated as 6% (95% confidence interval, -17% 24%). There no significant differences viral loads, antiretroviral-therapy initiation, the genetic characteristics infecting strains between treatment arms. Exploratory subgroup analyses showed nonsignificant trends toward preventing highest (VE, 43%; n=247) nonwhite 47%; n=914) (P=.10, adjusted multiple comparisons). Conclusions overall protective effect. subgroups may provide clues development effective immunization approaches.