Journal Article

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

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

2007

Overview

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-1 42 ( F 1,335 = 13.16; P < 0.001) and the Day 90 responses to MSP-1 42 ( F 1,335 = 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.

• Publisher: Elsevier Ltd,Elsevier
• Subject: Adjuvants, Immunologic - administration & dosage / Adjuvants, Immunologic - adverse effects / Adult / Allergy and Immunology / Animals / Antibodies, Protozoan - blood / Applied microbiology / AS02A / Biological and medical sciences / Double-Blind Method / Drug Combinations / Female / FMP1 / Fundamental and applied biological sciences. Psychology / Human protozoal diseases / Humans / Infectious diseases / Kenya / Lipid A - administration & dosage / Lipid A - adverse effects / Lipid A - analogs & derivatives / Lipid A - immunology / Malaria / Malaria Vaccines - administration & dosage / Malaria Vaccines - adverse effects / Malaria Vaccines - immunology / Malaria, Falciparum - immunology / Malaria, Falciparum - parasitology / Malaria, Falciparum - prevention & control / Male / Medical sciences / Merozoite surface protein / Merozoite Surface Protein 1 - chemistry / Merozoite Surface Protein 1 - genetics / Merozoite Surface Protein 1 - immunology / Microbiology / Middle Aged / Parasitic diseases / Plasmodium falciparum / Plasmodium falciparum - immunology / Protozoal diseases / Randomized controlled trials / Saponins - administration & dosage / Saponins - adverse effects / Saponins - immunology / Treatment Outcome / Vaccine / Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)