Breakthrough infections during phase 1 and 2 prime-boost HIV-1 vaccine trials with canarypox vectors (ALVAC) and booster dose of recombinant gp120 or gp160

J Infect Dis. 2004 Sep 1;190(5):903-7. doi: 10.1086/423284. Epub 2004 Jul 29.

Abstract

Candidate human immunodeficiency virus (HIV)-1 vaccines that elicit cytotoxic T lymphocytes may modulate HIV infection, requiring a prototype evaluation to assess participants who become infected with HIV. Of 1497 participants in canarypox HIV-1 vaccine prime-boost trials, 28 (1.9%) acquired HIV-1 infection after vaccination. Median plasma HIV-1 RNA levels (vaccinees, 4.78 log10 copies/mL; placebo recipients, 4.27 log10 copies/mL) and CD4 cell counts (vaccinees, 552 cells/mm3; placebo recipients, 657 cells/mm3) before administration of antiretroviral therapy (ART) and time to a composite end point (plasma HIV-1 RNA level >55,000 copies/mL, CD4 cell count <350 cells/mm3, or initiation of ART) did not differ significantly between vaccinees and placebo recipients (P =.4, P =.1, and P =.7, respectively). Persons who acquire HIV-1 infection while enrolled in HIV-1 vaccine trials can be successfully followed after infection, to determine whether vaccines alter the course of HIV-1 infection.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS Vaccines / administration & dosage*
  • AIDS Vaccines / immunology
  • Avipoxvirus / genetics*
  • Double-Blind Method
  • Female
  • Genetic Vectors / administration & dosage
  • Genetic Vectors / genetics
  • Genetic Vectors / immunology
  • HIV Envelope Protein gp120 / administration & dosage*
  • HIV Envelope Protein gp120 / genetics
  • HIV Envelope Protein gp120 / immunology
  • HIV Envelope Protein gp160 / administration & dosage*
  • HIV Envelope Protein gp160 / genetics
  • HIV Envelope Protein gp160 / immunology
  • HIV Infections / physiopathology*
  • HIV Infections / prevention & control
  • HIV-1 / pathogenicity*
  • Humans
  • Immunization
  • Immunization, Secondary
  • Male
  • RNA, Viral / blood
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / genetics
  • Recombinant Proteins / immunology

Substances

  • AIDS Vaccines
  • ALVAC-HIV vCP1452
  • ALVAC-HIV-1 vCP205
  • HIV Envelope Protein gp120
  • HIV Envelope Protein gp160
  • RNA, Viral
  • Recombinant Proteins