Continued follow-up of Phambili Phase 2b randomized HIV-1 vaccine trial participants supports increased HIV-1 acquisition among vaccinated men

 

Show simple item record

dc.contributor.author Moodie, Zoe en_ZA
dc.contributor.author Metch, Barbara en_ZA
dc.contributor.author Bekker, Linda-Gail en_ZA
dc.contributor.author Churchyard, Gavin en_ZA
dc.contributor.author Nchabeleng, Maphoshane en_ZA
dc.contributor.author Mlisana, Koleka en_ZA
dc.contributor.author Laher, Fatima en_ZA
dc.contributor.author Roux, Surita en_ZA
dc.contributor.author Mngadi, Kathryn en_ZA
dc.contributor.author Innes, Craig en_ZA
dc.date.accessioned 2015-11-23T12:25:33Z
dc.date.available 2015-11-23T12:25:33Z
dc.date.issued 2015 en_ZA
dc.identifier.citation Moodie, Z., Metch, B., Bekker, L. G., Churchyard, G., Nchabeleng, M., Mlisana, K., ... & Gray, G. E. (2015). Continued follow-up of Phambili Phase 2b randomized HIV-1 vaccine trial participants supports increased HIV-1 acquisition among vaccinated men. PloS one, 10(9), e0137666. doi:10.1371/journal.pone.0137666 en_ZA
dc.identifier.uri http://hdl.handle.net/11427/15270
dc.identifier.uri http://dx.doi.org/10.1371/journal.pone.0137666
dc.description.abstract BACKGROUND: The Phase 2b double-blinded, randomized Phambili/HVTN 503 trial evaluated safety and efficacy of the MRK Ad5 gag / pol / nef subtype B HIV-1 preventive vaccine vs placebo in sexually active HIV-1 seronegative participants in South Africa. Enrollment and vaccinations stopped and participants were unblinded but continued follow-up when the Step study evaluating the same vaccine in the Americas, Caribbean, and Australia was unblinded for non-efficacy. Final Phambili analyses found more HIV-1 infections amongst vaccine than placebo recipients, impelling the HVTN 503-S recall study. METHODS: HVTN 503-S sought to enroll all 695 HIV-1 uninfected Phambili participants, provide HIV testing, risk reduction counseling, physical examination, risk behavior assessment and treatment assignment recall. After adding HVTN 503-S data, HIV-1 infection hazard ratios (HR vaccine vs. placebo) were estimated by Cox models. RESULTS: Of the 695 eligible, 465 (67%) enrolled with 230 from the vaccine group and 235 from the placebo group. 38% of the 184 Phambili dropouts were enrolled. Enrollment did not differ by treatment group, gender, or baseline HSV-2. With the additional 1286 person years of 503-S follow-up, the estimated HR over Phambili and HVTN 503-S follow-up was 1.52 (95% CI 1.08-2.15, p = 0.02, 82 vaccine/54 placebo infections). The HR was significant for men (HR = 2.75, 95% CI 1.49, 5.06, p = 0.001) but not for women (HR = 1.12, 95% CI 0.73, 1.72, p = 0.62). CONCLUSION: The additional follow-up from HVTN 503-S supported the Phambili finding of increased HIV-1 acquisition among vaccinated men and strengthened the evidence of lack of vaccine effect among women. Trial Registration clinicaltrials.gov NCT00413725 SA National Health Research Database DOH-27-0207-1539 en_ZA
dc.language.iso eng en_ZA
dc.publisher Public Library of Science en_ZA
dc.rights This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. en_ZA
dc.rights.uri http://creativecommons.org/licenses/by/4.0 en_ZA
dc.source PLoS One en_ZA
dc.source.uri http://journals.plos.org/plosone en_ZA
dc.subject.other HIV-1 en_ZA
dc.subject.other Circumcision en_ZA
dc.subject.other HIV en_ZA
dc.subject.other HIV vaccines en_ZA
dc.subject.other Vaccines en_ZA
dc.subject.other Vaccination and immunization en_ZA
dc.subject.other Behavior en_ZA
dc.subject.other Recombinant vaccines en_ZA
dc.title Continued follow-up of Phambili Phase 2b randomized HIV-1 vaccine trial participants supports increased HIV-1 acquisition among vaccinated men en_ZA
dc.type Journal Article en_ZA
dc.rights.holder © 2015 Moodie et al en_ZA
uct.type.publication Research en_ZA
uct.type.resource Article en_ZA
dc.publisher.institution University of Cape Town
dc.publisher.faculty Faculty of Health Sciences en_ZA
dc.publisher.department Desmond Tutu HIV Centre en_ZA
uct.type.filetype Text
uct.type.filetype Image


Files in this item

This item appears in the following Collection(s)

Show simple item record

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Except where otherwise noted, this item's license is described as This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.