Phase 1 evaluation of 3 highly immunogenic prime-boost regimens, including a 12-month reboosting vaccination, for malaria vaccination in Gambian men

J Infect Dis. 2004 Jun 15;189(12):2213-9. doi: 10.1086/421118. Epub 2004 May 24.

Abstract

Successful vaccination against intracellular pathogens, including liver-stage Plasmodium falciparum, will require induction of strong antigen-specific T lymphocyte responses. The multiple epitope (ME)-thrombospondin-related adhesion protein (TRAP) construct includes CD8(+) and CD4(+) T cell epitopes from pre-erythrocytic P. falciparum antigens fused in-frame to the entire pre-erythrocytic antigen TRAP. Three carriers for this construct--plasmid DNA and 2 recombinant nonreplicating poxviruses (modified vaccinia virus Ankara [MVA] and fowlpox strain 9 [FP9])--were administered at 3-week intervals in a heterologous prime-boost combination to 29 Gambian men aged 18-45 years. Doses of DNA ME-TRAP, MVA ME-TRAP, and FP9 ME-TRAP were 2 mg and 1.5x10(8) and 1x10(8) plaque-forming units, respectively. DNA ME-TRAP was injected intramuscularly; MVA ME-TRAP and FP9 ME-TRAP were injected intradermally. There were no clinically relevant laboratory abnormalities and no severe or serious adverse events related to vaccination. DNA/MVA and FP9/MVA regimens were the most potent inducers of circulating effector T cells seen to date in sub-Saharan Africa. Twelve months after the final vaccination, a single booster vaccination expanded the effector T cell pool to a similar or higher magnitude than that after the primary vaccinations. These results highlight optimized combination regimens with general relevance to the development of vaccines targeting intracellular pathogens.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Adolescent
  • Adult
  • Animals
  • Epitopes, T-Lymphocyte / immunology
  • Gambia
  • Humans
  • Immunization
  • Immunization Schedule
  • Immunization, Secondary
  • Interferon-gamma / biosynthesis
  • Malaria Vaccines / administration & dosage*
  • Malaria Vaccines / adverse effects
  • Malaria Vaccines / immunology*
  • Malaria, Falciparum / immunology
  • Malaria, Falciparum / prevention & control*
  • Male
  • Middle Aged
  • Plasmodium falciparum / immunology
  • Protozoan Proteins / genetics
  • Protozoan Proteins / immunology*
  • T-Lymphocytes / immunology
  • Vaccination
  • Vaccines, DNA / administration & dosage*
  • Vaccines, DNA / adverse effects
  • Vaccines, DNA / immunology*
  • Vaccinia virus / genetics

Substances

  • Epitopes, T-Lymphocyte
  • Malaria Vaccines
  • Protozoan Proteins
  • Vaccines, DNA
  • thrombospondin-related adhesive protein, protozoan
  • Interferon-gamma