Phase 1 randomized double-blind safety and immunogenicity trial ofPlasmodium falciparummalaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya

• Published in: Vaccine Vol. 25; no. 1; p. 176
• Main Authors: Stoute, José A, Gombe, Joash, Withers, Mark R, Siangla, Joram, McKinney, Denise, Onyango, Melanie, Cummings, James F, Milman, Jessica, Tucker, Kathryn, Soisson, Lorraine, Stewart, V Ann, Lyon, Jeffrey A, Angov, Evelina, Leach, Amanda, Cohen, Joe, Kester, Kent E, Ockenhouse, Christian F, Holland, Carolyn A, Diggs, Carter L, Wittes, Janet, Gray Heppner, D
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Limited 02-01-2007
• Subjects: Appropriate technology; Confidence intervals; Drug dosages; E coli; Family medical history; Good Manufacturing Practice; Immunization; Immunogenicity; Malaria; Proteins; Rabies; Tropical diseases; Vaccines; Vector-borne diseases
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2005.11.037

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 ofPlasmodium 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 24h 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.