MODULATION OF IMMUNOLOGICAL RESPONSES TO HIV-1(MN) RECOMBINANT GP160 VACCINE BY DOSE AND SCHEDULE OF ADMINISTRATION

The safety and immunogenicity of HIV-1(MN) recombinant gp160 (MN rgp16 0) vaccine in healthy, uninfected volunteers was tested in a double-bl ind study with a factorial design. By random assignment, 20 volunteers received three 200 mu g doses of MN rgp160 and four volunteers receiv ed placebo at days 0, 28, and 168 or 0, 56, and 224. Of the 24 volunte ers, 16 received 200 mu g or 800 mu g of MN rgp160 and two received pl acebo at day 532 (month 18). The vaccine was safe. It induced T cell m emory measured by Th1 cytokine production and lymphocyte proliferation , and serum anti-MN rgp160 IgG (all subclasses) and IgA antibodies. Fi fteen of 20 vaccinees developed neutralizing antibody. The regimen inc luding immunizations on days 0, 28, and 168 followed by the 800 Icg fo urth dose was most immunogenic. (C) 1998 Elsevier Science Ltd. All lig hts reserved.