Overview
Publication
J Infect Dis. 2012 Jul 15; 206(2):258-66.
PubMed ID: 22561365
Title
Extended follow-up confirms early vaccine-enhanced risk of HIV acquisition and demonstrates waning effect over time among participants in a randomized trial of recombinant adenovirus HIV vaccine (Step study)
Authors
Duerr A, Huang Y, Buchbinder S, Coombs RW, Sanchez J, Del Rio C, Casapia M, Santiago S, Gilbert P, Corey L, Robertson MN; for the Step / HVTN 504 Study Team
Abstract
The Step Study tested whether an adenovirus serotype 5 (Ad5)-vectored human immunodeficiency virus (HIV) vaccine could prevent HIV acquisition and/or reduce viral load set-point after infection. At the first interim analysis, nonefficacy criteria were met. Vaccinations were halted; participants were unblinded. In post hoc analyses, more HIV infections occurred in vaccinees vs placebo recipients in men who had Ad5-neutralizing antibodies and/or were uncircumcised. Follow-up was extended to assess relative risk of HIV acquisition in vaccinees vs placebo recipients over time.
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