A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults

Summary

To extend the evaluation of safety and immunogenicity of MN recombinant soluble gp120/HIV-1 (MN rsgp120/HIV-1) in combination with QS21 with or without alum and on two different vaccination schedules. Recent animal studies indicate that immunizing with MN rsgp120/HIV-1 in combination with QS21 on a 0, 1, 2 month schedule results in a more rapid rise in binding and neutralizing antibody response than on a 0, 1, 6 month schedule. Such an effect may be particularly desirable in vaccine delivery. This study compares these two delivery schedules using the unadjuvanted vaccine formulation rsgp120/HIV-1 with or without addition of alum.

Timeline

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Primary completion

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Completion

1997-09

Publications

• Background Zolla-Pazner S, Alving C, Belshe R, Berman P, Burda S, Chigurupati P, Clements ML, Duliege AM, Excler JL, Hioe C, Kahn J, McElrath MJ, Sharpe S, Sinangil F, Steimer K, Walker MC, Wassef N, Xu S. Neutralization of a clade B primary isolate by sera from human immunodeficiency virus-uninfected recipients of candidate AIDS vaccines. J Infect Dis. 1997 Apr;175(4):764-74. doi: 10.1086/513969.
• Background Evans TG, McElrath MJ, Matthews T, Montefiori D, Weinhold K, Wolff M, Keefer MC, Kallas EG, Corey L, Gorse GJ, Belshe R, Graham BS, Spearman PW, Schwartz D, Mulligan MJ, Goepfert P, Fast P, Berman P, Powell M, Francis D; NIAID AIDS Vaccine Evaluation Group. QS-21 promotes an adjuvant effect allowing for reduced antigen dose during HIV-1 envelope subunit immunization in humans. Vaccine. 2001 Feb 28;19(15-16):2080-91. doi: 10.1016/s0264-410x(00)00415-1.

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