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
; 25(1): 176-84, 2007 Jan 02.
Article
em En
| MEDLINE
| ID: mdl-16388879
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.
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Base de dados:
MEDLINE
Assunto principal:
Saponinas
/
Adjuvantes Imunológicos
/
Malária Falciparum
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Proteína 1 de Superfície de Merozoito
/
Lipídeo A
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Animals
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Female
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Humans
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Male
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Middle aged
País como assunto:
Africa
Idioma:
En
Ano de publicação:
2007
Tipo de documento:
Article