Safety and immunogenicity of recombinant low-dosage HIV-1 A vaccine candidates vectored by plasmid pTHr DNA or modified vaccinia virus Ankara (MVA) in humans in East Africa

Vaccine. 2008 May 23;26(22):2788-95. doi: 10.1016/j.vaccine.2008.02.071. Epub 2008 Mar 31.

Abstract

The safety and immunogenicity of plasmid pTHr DNA, modified vaccinia virus Ankara (MVA) human immunodeficiency virus type 1 (HIV-1) vaccine candidates were evaluated in four Phase I clinical trials in Kenya and Uganda. Both vaccines, expressing HIV-1 subtype A gag p24/p17 and a string of CD8 T-cell epitopes (HIVA), were generally safe and well-tolerated. At the dosage levels and intervals tested, the percentage of vaccine recipients with HIV-1-specific cell-mediated immune responses, assessed by a validated ex vivo interferon gamma (IFN-gamma) ELISPOT assay and Cytokine Flow Cytometry (CFC), did not significantly differ from placebo recipients. These trials demonstrated the feasibility of conducting high-quality Phase 1 trials in Africa.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS Vaccines / adverse effects*
  • AIDS Vaccines / immunology*
  • Adult
  • Epitopes, T-Lymphocyte / genetics
  • Epitopes, T-Lymphocyte / immunology
  • Female
  • Flow Cytometry
  • Genetic Vectors
  • HIV-1 / immunology*
  • Humans
  • Interferon-gamma / biosynthesis
  • Kenya
  • Leukocytes, Mononuclear / immunology
  • Male
  • Placebos / administration & dosage
  • Plasmids
  • Uganda
  • Vaccines, DNA / genetics
  • Vaccines, DNA / immunology*
  • Vaccinia virus / genetics
  • gag Gene Products, Human Immunodeficiency Virus / genetics
  • gag Gene Products, Human Immunodeficiency Virus / immunology

Substances

  • AIDS Vaccines
  • Epitopes, T-Lymphocyte
  • Placebos
  • Vaccines, DNA
  • gag Gene Products, Human Immunodeficiency Virus
  • Interferon-gamma