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dc.contributor.authorPrasert Thongcharoenen_US
dc.contributor.authorVinai Suriyanonen_US
dc.contributor.authorRobert M. Parisen_US
dc.contributor.authorChirasak Khamboonruangen_US
dc.contributor.authorMark S. De Souzaen_US
dc.contributor.authorSilvia Ratto-Kimen_US
dc.contributor.authorChitraporn Karnasutaen_US
dc.contributor.authorVictoria R. Polonisen_US
dc.contributor.authorLynn Baglyosen_US
dc.contributor.authorRaphaelle El Habiben_US
dc.contributor.authorSanjay Gurunathanen_US
dc.contributor.authorSusan Barnetten_US
dc.contributor.authorArthur E. Brownen_US
dc.contributor.authorDeborah L. Birxen_US
dc.contributor.authorJohn G. McNeilen_US
dc.contributor.authorJerome H. Kimen_US
dc.description.abstractBACKGROUND: The development of an effective HIV-1 vaccine is critical to control the pandemic. A prime-boost HIV-1 vaccine trial assessing safety and immunogenicity was conducted in Thailand as part of an evaluation of candidate regimens for a phase 3 efficacy trial. METHODS: ALVAC-HIV (vCP1521), expressing circulating recombinant form 01_AE (CRF01_AE) gp120/subtype B LAI and subtype B Gag/Protease boosted with recombinant envelope oligomeric CRF01_AE gp160 (ogp160) or bivalent CRF01_AE/subtype B gp120 CM235/SF2, was evaluated in a phase 1/II trial of 130 HIV-negative Thai adults. RESULTS: One hundred forty volunteers were enrolled, and 130 completed all safety and immunogenicity visits. Reactogenicity was common but generally mild, and there was no significant difference in the adverse event rate between vaccine and placebo recipients (P = 0.26). There were 7 serious adverse events during the follow-up period, none of which were vaccine related. Cumulative HIV-specific, CD8-mediated, cytotoxic T-lymphocyte responses were observed in 11 (25%) of 44 subjects who received ALVAC boosted by bivalent gp120 and in 5 (11%) of 45 subjects who received ALVAC boosted by ogp160, but these differences were not statistically significant compared with those in placebo recipients (P = 0.62 and P = 0.37, respectively). HIV-specific lymphoproliferative responses were detected in 84% of subunit-boosted vaccine recipients and in 10% of placebo recipients. Neutralizing antibody responses to CRF01_AE and subtype B laboratory strains were seen in 95% of ogp160-boosted and 100% of gp120 B/E-boosted vaccinees, respectively. CONCLUSIONS: These 2 different prime-boost regimens seem to be safe and displayed cell-mediated immune responses consistent with those in other trials of canarypox vectors. © 2007 Lippincott Williams & Wilkins, Inc.en_US
dc.titleA phase 1/2 comparative vaccine trial of the safety and immunogenicity of a CRF01_AE (subtype E) candidate vaccine: ALVAC-HIV (vCP1521) prime with oligomeric gp160 (92TH023/LAI-DID) or bivalent gp120 (CM235/SF2) boosten_US
article.title.sourcetitleJournal of Acquired Immune Deficiency Syndromesen_US
article.volume46en_US of Medicine, Siriraj Hospital, Mahidol Universityen_US Mai Universityen_US Forces Research Institute of Medical Sciences, Thailanden_US Pasteuren_US Pasteur SAen_US Vaccines and Diagnostics, Inc.en_US Army Medical Materiel Development Activityen_US for Disease Control and Preventionen_US Malaria Vaccine Initiativeen_US Universityen_US
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