Safety and immunogenicity of an HIV subtype B and E prime-boost vaccine combination in HIV-negative Thai adults

J Infect Dis. 2004 Aug 15;190(4):702-6. doi: 10.1086/422258. Epub 2004 Jul 20.

Abstract

ALVAC-HIV (vCP1521) and AIDSVAX B/E were evaluated in a phase 1/2 trial of human immunodeficiency virus (HIV)-negative Thai adults. Of 133 volunteers enrolled, 122 completed the trial. There were no serious vaccine-related adverse events, nor were there intercurrent HIV infections. Lymphoproliferative responses to glycoprotein 120 E were induced in 63% of the volunteers, and HIV-specific CD8 cytotoxic T lymphocyte responses were induced in 24%. Antibody responses increased in frequency and magnitude in association with the dose level of AIDSVAX B/E. Binding and neutralizing antibodies to the MN strain were induced in 100% and 98%, respectively, of the volunteers receiving 600 microg of AIDSVAX B/E, and such antibodies to E strains were induced in 96% and 71%, respectively, of these volunteers. This vaccine combination was well tolerated and was immunogenic, meeting milestones for advancement to phase 3 evaluation.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • AIDS Vaccines / administration & dosage*
  • AIDS Vaccines / adverse effects
  • AIDS Vaccines / immunology*
  • Adult
  • CD8-Positive T-Lymphocytes / immunology
  • Cytotoxicity, Immunologic
  • Female
  • HIV Antibodies / biosynthesis
  • HIV Antibodies / blood
  • HIV Envelope Protein gp120 / immunology
  • HIV Envelope Protein gp120 / pharmacology
  • HIV Infections / blood
  • HIV Infections / immunology*
  • HIV Infections / prevention & control*
  • HIV Seronegativity / immunology*
  • Humans
  • Immunization Schedule
  • Immunization, Secondary
  • Leukocytes, Mononuclear / immunology
  • Lymphocyte Activation
  • Male
  • Middle Aged
  • Neutralization Tests
  • Thailand
  • Time Factors
  • Vaccination*

Substances

  • AIDS Vaccines
  • HIV Antibodies
  • HIV Envelope Protein gp120