Mj. Mcelrath et al., 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 RES H, 16(9), 2000, pp. 907-919
Several immunogens induce HIV-specific neutralization and in vitro lymphopr
oliferation in adults at low HIV-1 risk, but responses in persons at high H
IV-1 risk are not known, We performed a multicenter. double-blinded, adjuva
nt-controlled trial with two gp120 vaccines in 296 HIV-1-uninfected volunte
ers, including 176 reporting higher HIV-1 risk activities. The immunogens w
ere remarkably well tolerated, After three immunizations, 210 of 241 vaccin
ees (87%) developed neutralizing antibodies, which persisted in 59% after 2
years. The injection drug users receiving SF-2/gp120 had decreased antibod
y responses relative to the lower risk groups. Envelope-specific lymphoprol
iferation peaked after two immunizations, and 54% of vaccinees. mounted a D
TH reaction to gp120 after 4 years. In summary, these immunogens have low a
dverse reactogenicity and induce durable antibody and T cell responses to t
he prototype strains, Unexpected differences in antibody responses among di
verse HIV-1 risk strata lend support to the conduct of expanded phase II tr
ials in populations other than low-risk volunteers.