11th International AIDS Conference Vancouver, British Columbia — July 7-12, 1996

Int Conf AIDS 1996 Jul 7-12; 11:7 (abstract no. Mo.A.153)
Gorse GJ, McElrath MJ, Belshe RB, Corey L, Matthews T, Eibl M, Kennedy D, Frey S, Hsieh R, Walker MC; Division of Infectious Diseases, Saint Louis Univ. Health Sciences Center, St. Louis, MO. Fax: 314-771-3816. E-mail: gorsemd@sluvca.slu.edu.

OBJECTIVE: To evaluate the safety and immunogenicity of a mammalian cell-produced HIV-1 MN rgp160 vaccine (IMMUNO-AG) at a high dose in low-risk, HIV-1 uninfected volunteers.

METHODS: In an ongoing, double-blind, randomized study, subjects received 800 micrograms MN rgp160 at 0,1, and 6 months (N=8) or at 0,2, and 8 months (N=8); 4 subjects received placebo. Subjects (N=19) are receiving a fourth dose 6 months after the third. Clinical and laboratory safety, serum anti-rgp160 and V3 MN binding (ELISA) and HIV-1 MN neutralizing antibodies, and lymphocyte proliferation are being measured.

RESULTS: Local injection site pain of moderate severity on average occurred in all 20 subjects. Self-limited, mild to moderate systemic symptoms occurred in 5 vaccinees and 3 controls. Binding antibody responses 14 days post third vaccine dose were: (table: see text)

CONCLUSIONS: The vaccine was safe, and induced T cell memory and anti-rgp160 IgG (subclasses 1-4) and IgA binding antibodies. Compared to 200 micrograms, the 800 micrograms MN rgp160 doses given at 0,2, and 8 months better stimulated anti-V3 MN antibody. Anti-V3 antibody has correlated with neutralizing antibody against HIV-1 lab strains. In earlier studies, 200 micrograms doses of MN rgp160 induced neutralizing antibody against HIV-1 MN even in the absence of anti-V3 MN antibody. Anti-V3 antibody induced in this study may increase functional activity of these sera.

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MoA153

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