Vaccination of Vaccinia-Naive Adults with Human Immunodeficiency Virus Type 1 gp160 Recombinant Vaccinia Virus in a Blinded, Controlled, Randomized Clinical Trial.

The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-l) gp160 recombinant vaccinia virus (HIVAC-le) vaccine was evaluated in vaccinia-naive, healthy adults at low risk for acquiring HIV-l infection. Volunteers (n = 36) were randomized to receive HIVAC- l e or control vaccinia virus at two dosages by bifurcated needle puncture at 0 and 2 months; 12 HIVAC-le and 6 control vaccinia virus recipients received either 106 or 107 pfu/mL at each inoculation. There was no significant difference in lesion size, level of viral replication, or systemic symptoms after vaccination with HIVAC-le or control vaccinia virus. Of 22 HIVAC-le recipients with lesion formation, 16 developed low-titer gp 160-specific antibody responses detectable by Western blot. The peak response occurred between days 70 and 120 and was still detectable at day 365 in 9 of 18 vaccinees. gp 160-specific Iymphoproliferative responses were detected in 5 of 10 vaccinees. Vaccination with HIVAC-le was safe in vaccinia-naive, healthy adults and could induce both humoral and cell-mediated gp160-specific immune responses. [ABSTRACT FROM PUBLISHER]