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

José A. Stoute, Joash Gombe, Mark R. Withers, Joram Siangla, Denise McKinney, Melanie Onyango, James F. Cummings, Jessica Milman, Kathryn Tucker, Lorraine Soisson, V. Ann Stewart, Jeffrey A. Lyon, Evelina Angov, Amanda Leach, Joe Cohen, Kent E. Kester, Christian F. Ockenhouse, Carolyn A. Holland, Carter L. Diggs, Janet WittesD. Gray Heppner

Research output: Contribution to journalArticlepeer-review

62 Scopus citations

Abstract

We report the first trial of candidate malaria vaccine antigen FMP1, a 42 kDa 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-142 (F1,335 = 13.16; P < 0.001) and the Day 90 responses to MSP-142 (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.

Original languageEnglish (US)
Pages (from-to)176-184
Number of pages9
JournalVaccine
Volume25
Issue number1
DOIs
StatePublished - Jan 2 2007

All Science Journal Classification (ASJC) codes

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Fingerprint Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this