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Oxford University Press (OUP), The Journal of Infectious Diseases, 2(206), p. 258-266

DOI: 10.1093/infdis/jis342

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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)

Journal article published in 2012 by Ann Duerr, Carlos del Rio, Yunda Huang ORCID, Susan Buchbinder, Robert W. Coombs, Jorge Sanchez, C. Del Rio, Martin Casapia, Steven Santiago, Peter Gilbert, Lawrence Corey, Michael N. Robertson
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Background. 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.