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

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dc.contributor.authorMoodie, Zoeen_ZA
dc.contributor.authorMetch, Barbaraen_ZA
dc.contributor.authorBekker, Linda-Gailen_ZA
dc.contributor.authorChurchyard, Gavinen_ZA
dc.contributor.authorNchabeleng, Maphoshaneen_ZA
dc.contributor.authorMlisana, Kolekaen_ZA
dc.contributor.authorLaher, Fatimaen_ZA
dc.contributor.authorRoux, Suritaen_ZA
dc.contributor.authorMngadi, Kathrynen_ZA
dc.contributor.authorInnes, Craigen_ZA
dc.date.accessioned2015-11-23T12:25:33Z
dc.date.available2015-11-23T12:25:33Z
dc.date.issued2015en_ZA
dc.description.abstractBACKGROUND: 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-27-0207-1539en_ZA
dc.identifier.apacitationMoodie, Z., Metch, B., Bekker, L., Churchyard, G., Nchabeleng, M., Mlisana, K., ... Innes, C. (2015). Continued follow-up of Phambili Phase 2b randomized HIV-1 vaccine trial participants supports increased HIV-1 acquisition among vaccinated men. <i>PLoS One</i>, http://hdl.handle.net/11427/15270en_ZA
dc.identifier.chicagocitationMoodie, Zoe, Barbara Metch, Linda-Gail Bekker, Gavin Churchyard, Maphoshane Nchabeleng, Koleka Mlisana, Fatima Laher, Surita Roux, Kathryn Mngadi, and Craig Innes "Continued follow-up of Phambili Phase 2b randomized HIV-1 vaccine trial participants supports increased HIV-1 acquisition among vaccinated men." <i>PLoS One</i> (2015) http://hdl.handle.net/11427/15270en_ZA
dc.identifier.citationMoodie, 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.0137666en_ZA
dc.identifier.ris TY - Journal Article AU - Moodie, Zoe AU - Metch, Barbara AU - Bekker, Linda-Gail AU - Churchyard, Gavin AU - Nchabeleng, Maphoshane AU - Mlisana, Koleka AU - Laher, Fatima AU - Roux, Surita AU - Mngadi, Kathryn AU - Innes, Craig AB - 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 DA - 2015 DB - OpenUCT DO - 10.1371/journal.pone.0137666 DP - University of Cape Town J1 - PLoS One LK - https://open.uct.ac.za PB - University of Cape Town PY - 2015 T1 - Continued follow-up of Phambili Phase 2b randomized HIV-1 vaccine trial participants supports increased HIV-1 acquisition among vaccinated men TI - Continued follow-up of Phambili Phase 2b randomized HIV-1 vaccine trial participants supports increased HIV-1 acquisition among vaccinated men UR - http://hdl.handle.net/11427/15270 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/15270
dc.identifier.urihttp://dx.doi.org/10.1371/journal.pone.0137666
dc.identifier.vancouvercitationMoodie Z, Metch B, Bekker L, Churchyard G, Nchabeleng M, Mlisana K, et al. Continued follow-up of Phambili Phase 2b randomized HIV-1 vaccine trial participants supports increased HIV-1 acquisition among vaccinated men. PLoS One. 2015; http://hdl.handle.net/11427/15270.en_ZA
dc.language.isoengen_ZA
dc.publisherPublic Library of Scienceen_ZA
dc.publisher.departmentDesmond Tutu HIV Centreen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis 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.holder© 2015 Moodie et alen_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/4.0en_ZA
dc.sourcePLoS Oneen_ZA
dc.source.urihttp://journals.plos.org/plosoneen_ZA
dc.subject.otherHIV-1en_ZA
dc.subject.otherCircumcisionen_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherHIV vaccinesen_ZA
dc.subject.otherVaccinesen_ZA
dc.subject.otherVaccination and immunizationen_ZA
dc.subject.otherBehavioren_ZA
dc.subject.otherRecombinant vaccinesen_ZA
dc.titleContinued follow-up of Phambili Phase 2b randomized HIV-1 vaccine trial participants supports increased HIV-1 acquisition among vaccinated menen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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