Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial.
In: Lancet, Jg. 372 (2008-11-29), Heft 9653, S. 1881-1893
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Zugriff:
The article presents a randomised controlled trial, the Step Study, which examined the efficacy of a cell-mediated immunity HIV-1 vaccine. 3000 HIV-1 seronegative participants were randomly assigned to receive three injections of MRKAd5 HIV-1 gag/pol/nef vaccine or placebo. Safety, tolerability, and efficacy of the vaccine were the primary objectives. Efficacy was defined as the reduction in HIV-1 acquisition rates or a decrease in HIV-1 viral-load setpoint. The hazard ratio of HIV-1 infection between vaccine and placebo recipients was found to be higher in adenovirus type 5 (Ad5) seropositive men and uncircumcised men. The ratio had not increased for Ad5 seronegative or circumcised men. Researchers concluded that the vaccine did not prevent HIV-1 infection or reduce early viral load.
Titel: |
Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial.
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Autor/in / Beteiligte Person: | Buchbinder, Susan P. ; Mehrotra, Devan V. ; Duerr, Ann ; Fitzgerald, Daniel W. ; Mogg, Robin ; Li, David ; Gilbert, Peter B. ; Lama, Javier R. ; Marmor, Michael ; del Rio, Carlos ; McElrath, M. Juliana ; Casimiro, Danilo R. ; Gottesdiener, Keith M. ; Chodakewitz, Jeffrey A. ; Corey, Lawrence ; Robertson, Michael N. |
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Zeitschrift: | Lancet, Jg. 372 (2008-11-29), Heft 9653, S. 1881-1893 |
Veröffentlichung: | 2008 |
Medientyp: | academicJournal |
ISSN: | 0140-6736 (print) |
DOI: | 10.1016/S0140-6736(08)61591-3 |
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