A Phase 1/2 Comparative Vaccine Trial of the Safety and Immunogenicity of a CRF01_AE (Subtype E) Candidate Vaccine

• DOI: 10.1097/qai.0b013e3181354bd7
• Publication Date: 2007-07-06T08:21:17Z
• Authors: Prasert Thongcharoen; Vinai Suriyanon; Robert M Paris; Chirasak Khamboon...; Mark S de Souza; Silvia Ratto-Kim; Chitraporn Karnasuta; Victoria R Polonis; Lynn Baglyos; Raphaelle El Habib; Sanjay Gurunathan; Susan Barnett; Arthur E Brown; Deborah L Birx; John G McNeil; Jerome H Kim
• Keywords: Reactogenicity

The development of an effective HIV-1 vaccine is critical to control the pandemic. A prime-boost trial assessing safety and immunogenicity was conducted in Thailand as part evaluation candidate regimens for a phase 3 efficacy trial.ALVAC-HIV (vCP1521), expressing circulating recombinant form 01_AE (CRF01_AE) gp120/subtype B LAI subtype Gag/Protease boosted with envelope oligomeric CRF01_AE gp160 (ogp160) or bivalent CRF01_AE/subtype gp120 CM235/SF2, evaluated 1/II 130 HIV-negative Thai adults.One hundred forty volunteers were enrolled, completed all visits. Reactogenicity common but generally mild, there no significant difference adverse event rate between placebo recipients (P = 0.26). There 7 serious events during follow-up period, none which related. Cumulative HIV-specific, CD8-mediated, cytotoxic T-lymphocyte responses observed 11 (25%) 44 subjects who received ALVAC by 5 (11%) 45 ogp160, these differences not statistically compared those 0.62 P 0.37, respectively). HIV-specific lymphoproliferative detected 84% subunit-boosted 10% recipients. Neutralizing antibody laboratory strains seen 95% ogp160-boosted 100% B/E-boosted vaccinees, respectively.These 2 different seem be safe displayed cell-mediated immune consistent other trials canarypox vectors.