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.
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.
McElrath
M J
MJ
University of Washington School of Medicine and the Fred Hutchinson Cancer Research Center, Seattle 98109, USA. kd@u.washington.edu
Corey
L
L
Montefiori
D
D
Wolff
M
M
Schwartz
D
D
Keefer
M
M
Belshe
R
R
Graham
B S
BS
Matthews
T
T
Wright
P
P
Gorse
G
G
Dolin
R
R
Berman
P
P
Francis
D
D
Duliege
A M
AM
Bolognesi
D
D
Stablein
D
D
Ketter
N
N
Fast
P
P
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
D016915:AIDS Vaccines; D015483:HIV Antibodies; D015488:HIV Antigens; D015699:HIV Envelope Protein gp120; C059762:HIV envelope protein gp120 (305-321); D010446:Peptide Fragments