Phase I/II study of a candidate vaccine designed against the B and E subtypes of HIV-1

J Acquir Immune Defic Syndr. 2004 Sep 1;37(1):1160-5. doi: 10.1097/01.qai.0000136091.72955.4b.


A phase I/II trial of a candidate vaccine to prevent HIV infection was carried out in Bangkok, Thailand, testing AIDSVAX B/E (VaxGen, Inc., Brisbane, CA), a bivalent subunit vaccine prepared by combining recombinant gp120 from a subtype B virus (HIV-1MN) with gp120 from a subtype E virus (HIV-1A244) in alum adjuvant. The studies provide human data on the immunogenicity of various dose combination of non-subtype B vaccine antigens. The results suggest that AIDSVAX B/E is safe and immunogenic in humans. The optimal dose for humans in developing countries was 300 microg of each antigen (B and E). Clade E responses were measurably increased by immunizing with gp120 B/E over B alone. Using the B/E combination did not interfere with the response to either clade. Antibodies to AIDSVAX B/E were able to bind to oligomeric gp120 on the surface of cells infected with primary isolates of HIV-1.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II

MeSH terms

  • AIDS Vaccines / administration & dosage
  • AIDS Vaccines / adverse effects*
  • AIDS Vaccines / immunology*
  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / adverse effects
  • Adolescent
  • Adult
  • Alum Compounds
  • Female
  • HIV Antibodies / blood
  • HIV Envelope Protein gp120 / genetics
  • HIV Envelope Protein gp120 / immunology*
  • HIV Infections / immunology
  • HIV Infections / prevention & control*
  • HIV Infections / virology
  • HIV-1 / classification*
  • HIV-1 / genetics
  • HIV-1 / immunology*
  • Humans
  • Immunization Schedule
  • Male
  • Middle Aged
  • Recombinant Proteins / immunology
  • Substance Abuse, Intravenous / complications
  • Thailand
  • Vaccination


  • AIDS Vaccines
  • Adjuvants, Immunologic
  • Alum Compounds
  • HIV Antibodies
  • HIV Envelope Protein gp120
  • Recombinant Proteins
  • aluminum sulfate