Feasibility of human immunodeficiency virus vaccine trials in homosexual men in the United States: Risk behavior, seroincidence, and willingness to participate

Abstract

Human immunodeficiency virus (HIV)-seronegative high-risk homosexual men were enrolled in a vaccine feasibility study in three US cities. HIV seroincidence was 2.3/100 person-years (95% confidence interval [CI], 1.7- 2.9) over 18 months in 1975 men. After receiving an explanation of HIV vaccine trial design, 37% stated they were 'definitely' willing to participate in future trials; seroincidence was 3.7/100 person-years (95% CI, 2.5-4.9) in this subgroup. An additional 57% 'might be' or were 'probably' willing. Independent predictors of HIV seroconversion in multivariable pooled logistic regression analysis were having a known HIV-seropositive sex partner (odds ratio [OR], 4.5; 95% CI, 2.6-7.8), injection drug use (OR, 3.6; 95% CI, 1.2-10.7), unprotected receptive anal sex (OR, 2.4; 95% CI, 1.4-4.2), condom failure (OR, 2.4; 95% CI, 1.4-4.1), gonococcal/nongonococcal urethritis (OR, 2.3; 95% CI, 1.1-4.7), and age <25 years (OR, 2.2; 95% CI, 1.24.2). Interest in vaccine trials and seroincidence in high-risk homosexual men are sufficiently high to initiate efficacy trials once a suitable candidate vaccine is identified. Risk factors for seroconversion highlight important areas for development of ancillary intervention strategies.