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Vaccination of vaccinia-naive adults with human immunodeficiency virus type 1 gp160 recombinant vaccinia virus in a blinded, controlled, randomized clinical trial. The AIDS Vaccine Clinical Trials Network.

Abstract
The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) gp160 recombinant vaccinia virus (HIVAC-1e) vaccine was evaluated in vaccinia-naive, healthy adults at low risk for acquiring HIV-1 infection. Volunteers (n = 36) were randomized to receive HIVAC-1e or control vaccinia virus at two dosages by bifurcated needle puncture at 0 and 2 months; 12 HIVAC-1e and 6 control vaccinia virus recipients received either 10(6) or 10(7) pfu/mL at each inoculation. There was no significant difference in lesion size, level of viral replication, or systemic symptoms after vaccination with HIVAC-1e or control vaccinia virus. Of 22 HIVAC-1e recipients with lesion formation, 16 developed low-titer gp160-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. gp160-specific lymphoproliferative responses were detected in 5 of 10 vaccinees. Vaccination with HIVAC-1e was safe in vaccinia-naive, healthy adults and could induce both humoral and cell-mediated gp160-specific immune responses.
AuthorsB S Graham, R B Belshe, M L Clements, R Dolin, L Corey, P F Wright, G J Gorse, K Midthun, M C Keefer, N J Roberts Jr
JournalThe Journal of infectious diseases (J Infect Dis) Vol. 166 Issue 2 Pg. 244-52 (Aug 1992) ISSN: 0022-1899 [Print] United States
PMID1353102 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • AIDS Vaccines
  • Antibodies, Viral
  • Gene Products, env
  • HIV Antibodies
  • HIV Envelope Protein gp160
  • HIVAC-1e
  • Protein Precursors
  • Vaccines, Synthetic
Topics
  • AIDS Vaccines (adverse effects, immunology)
  • Acquired Immunodeficiency Syndrome (prevention & control)
  • Adult
  • Antibodies, Viral (biosynthesis)
  • CD4-Positive T-Lymphocytes
  • Double-Blind Method
  • Female
  • Gene Products, env (immunology)
  • HIV Antibodies (biosynthesis)
  • HIV Envelope Protein gp160
  • HIV-1 (immunology)
  • Humans
  • Immunization, Secondary
  • Leukocyte Count
  • Lymphocyte Activation
  • Male
  • Middle Aged
  • Protein Precursors (immunology)
  • Vaccination
  • Vaccines, Synthetic (adverse effects, immunology)
  • Vaccinia virus (genetics, immunology, physiology)
  • Virus Replication

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