Safety and Immunogenicity of a High-Titered Canarypox Vaccine in Combination With rgp120 in a Diverse Population of HIV-1-Uninfected Adults: AIDS Vaccine Evaluation Group Protocol 022A.

Gupta, Kalpana; Hudgens, Michael; Corey, Lawrence; McElrath, Juliana M.; Weinhold, Kent; Montefiori, David C.; Gorse, Geoffrey J.; Frey, Sharon E.; Keefer, Michael C.; Evans, Thomas G.; Dolin, Raphael; Schwartz, David H.; Harro, Clayton; Graham, Barney; Spearman, Paul W.; Mulligan, Mark; Goepfert, Paul; the AIDS Vaccine Evaluation Group
JAIDS Journal of Acquired Immune Deficiency Syndromes: March 1, 2002
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: To test the safety and immunogenicity of a high-titered preparation of ALVAC-HIV vCP205 in both high-risk and low-risk persons and to evaluate variations in dosing schedule, we conducted a multicenter, randomized, double-blind trial of this vector in combination with recombinant subunit gp120 in 150 HIV-1-seronegative volunteers. The high-titered ALVAC vaccine was well tolerated; adverse events were minimal and not influenced by dosing. At day 728, the cumulative probability of a cytotoxic T-lymphocyte (CTL) response was 76% (95% confidence interval [CI]: 64%-89%) among volunteers receiving vaccine, and the net amount attributable to vaccination was 50% (CI: 16%; 74%). The net probability of a repeated positive CTL response by day 728 was 50% (CI: 21%; 64%). There was a significant difference in CTL response at day 182 between volunteers who had received four doses versus three doses of vCP205 (42% vs. 24%, p = .052). The CTL response was similar in high-risk volunteers and vaccinia-naive volunteers compared with vacciniaimmune volunteers. Neutralizing antibody responses were detected in 95% of vaccinees at day 287, with higher geometric mean titers in recipients of sequential versus simultaneous dosing of the two vaccines and in vaccinia-naive volunteers. This hightitered preparation of ALVAC-HIV vCP205 in combination with gpl20 was safe and immunogenic in a diverse group of HIV-1-seronegative volunteers.

(C) 2002 Lippincott Williams & Wilkins, Inc.