Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya

Vaccine. 2007 Jan 2;25(1):176-84. doi: 10.1016/j.vaccine.2005.11.037. Epub 2005 Dec 7.

Abstract

We report the first trial of candidate malaria vaccine antigen FMP1, a 42kDa fragment from the C-terminus of merozoite surface protein-1 (MSP-1) from the 3D7 strain of Plasmodium falciparum, in an endemic area. Forty adult male and female residents of western Kenya were enrolled to receive 3 doses of either FMP1/AS02A or Imovax rabies vaccine by intra-deltoid injection on a 0, 1, 2 month schedule. Thirty-seven volunteers received all three immunizations and 38 completed the 12-month evaluation period. Slightly more recipients of the FMP1/AS02A vaccine experienced any instance of pain at 24 h post-immunization than in the Imovax group (95% versus 65%), but otherwise the two vaccines were equally safe and well-tolerated. Baseline antibody levels were high in both groups and were boosted in the FMP1/AS02A group. Longitudinal models revealed a highly significant difference between groups for both the average post-baseline antibody responses to MSP-1(42) (F1,335=13.16; P<0.001) and the Day 90 responses to MSP-1(42) (F1,335=16.69; P<0.001). The FMP1/AS02A vaccine is safe and immunogenic in adults and should progress to safety testing in children at greatest risk of malaria.

Publication types

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

MeSH terms

  • Adjuvants, Immunologic* / administration & dosage
  • Adjuvants, Immunologic* / adverse effects
  • Adult
  • Animals
  • Antibodies, Protozoan / blood
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Humans
  • Kenya
  • Lipid A / administration & dosage
  • Lipid A / adverse effects
  • Lipid A / analogs & derivatives*
  • Lipid A / immunology
  • Malaria Vaccines / administration & dosage
  • Malaria Vaccines / adverse effects
  • Malaria Vaccines / immunology
  • Malaria, Falciparum / immunology
  • Malaria, Falciparum / parasitology
  • Malaria, Falciparum / prevention & control*
  • Male
  • Merozoite Surface Protein 1 / chemistry
  • Merozoite Surface Protein 1 / genetics
  • Merozoite Surface Protein 1 / immunology*
  • Middle Aged
  • Plasmodium falciparum / immunology
  • Saponins* / administration & dosage
  • Saponins* / adverse effects
  • Saponins* / immunology
  • Treatment Outcome

Substances

  • ASO2A adjuvant
  • Adjuvants, Immunologic
  • Antibodies, Protozoan
  • Drug Combinations
  • Lipid A
  • Malaria Vaccines
  • Merozoite Surface Protein 1
  • Saponins