title: A phase II study of two HIV type 1 envelope vaccines, comparing their immunogenicity in populations at risk for acquiring HIV type 1 infection. AIDS Vaccine Evaluation Group.
abstract: Several immunogens induce HIV-specific neutralization and in vitro lymphoproliferation in adults at low HIV-1 risk, but responses in persons at high HIV-1 risk are not known. We performed a multicenter, double-blinded, adjuvant-controlled trial with two gp120 vaccines in 296 HIV-1-uninfected volunteers, including 176 reporting higher HIV-1 risk activities. The immunogens were remarkably well tolerated. After three immunizations, 210 of 241 vaccinees (87%) developed neutralizing antibodies, which persisted in 59% after 2 years. The injection drug users receiving SF-2/gp120 had decreased antibody responses relative to the lower risk groups. Envelope-specific lymphoproliferation peaked after two immunizations, and 54% of vaccinees mounted a DTH reaction to gp120 after 4 years. In summary, these immunogens have low adverse reactogenicity and induce durable antibody and T cell responses to the prototype strains. Unexpected differences in antibody responses among diverse HIV-1 risk strata lend support to the conduct of expanded phase II trials in populations other than low-risk volunteers.
authors.affiliation: University of Washington School of Medicine and the Fred Hutchinson Cancer Research Center, Seattle 98109, USA. kd@u.washington.edu
authors.forename: M J
authors.initials: MJ
authors.lastname: McElrath
authors.forename: L
authors.initials: L
authors.lastname: Corey
authors.forename: D
authors.initials: D
authors.lastname: Montefiori
authors.forename: M
authors.initials: M
authors.lastname: Wolff
authors.forename: D
authors.initials: D
authors.lastname: Schwartz
authors.forename: M
authors.initials: M
authors.lastname: Keefer
authors.forename: R
authors.initials: R
authors.lastname: Belshe
authors.forename: B S
authors.initials: BS
authors.lastname: Graham
authors.forename: T
authors.initials: T
authors.lastname: Matthews
authors.forename: P
authors.initials: P
authors.lastname: Wright
authors.forename: G
authors.initials: G
authors.lastname: Gorse
authors.forename: R
authors.initials: R
authors.lastname: Dolin
authors.forename: P
authors.initials: P
authors.lastname: Berman
authors.forename: D
authors.initials: D
authors.lastname: Francis
authors.forename: A M
authors.initials: AM
authors.lastname: Duliege
authors.forename: D
authors.initials: D
authors.lastname: Bolognesi
authors.forename: D
authors.initials: D
authors.lastname: Stablein
authors.forename: N
authors.initials: N
authors.lastname: Ketter
authors.forename: P
authors.initials: P
authors.lastname: Fast
mesh_terms: D016915:AIDS Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000494:pharmacology*; D000293:Adolescent; D000328:Adult; D000595:Amino Acid Sequence; D004311:Double-Blind Method; D005260:Female; D015483:HIV Antibodies / Q000096:biosynthesis; D015488:HIV Antigens / Q000235:genetics; D015699:HIV Envelope Protein gp120 / Q000276:immunology; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control*; D015497:HIV-1 / Q000235:genetics / Q000276:immunology; D006801:Humans; D006968:Hypersensitivity, Delayed; D066298:In Vitro Techniques; D008213:Lymphocyte Activation; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D009500:Neutralization Tests; D010446:Peptide Fragments / Q000276:immunology; D012309:Risk-Taking; D012449:Safety; D013997:Time Factors
chemical_list: D016915:AIDS Vaccines; D015483:HIV Antibodies; D015488:HIV Antigens; D015699:HIV Envelope Protein gp120; C059762:HIV envelope protein gp120 (305-321); D010446:Peptide Fragments