A human phase 1 vaccine clinical trial of the Plasmodium falciparum malaria vaccine candidate apical membrane antigen 1 in Montanide ISA720 adjuvant

A Saul; G Lawrence; A Allworth; S Elliott; K Anderson; C Rzepczyk; LB Martin; D Taylor; DP Eisen; DO Irving; D Pye; PE Crewther; AN Hodder; VJ Murphy; RF Anders

Journal article

A human phase 1 vaccine clinical trial of the Plasmodium falciparum malaria vaccine candidate apical membrane antigen 1 in Montanide ISA720 adjuvant

A Saul, G Lawrence, A Allworth, S Elliott, K Anderson, C Rzepczyk, LB Martin, D Taylor, DP Eisen, DO Irving, D Pye, PE Crewther, AN Hodder, VJ Murphy, RF Anders

Vaccine | Published : 2005

DOI: 10.1016/j.vaccine.2004.09.040

Abstract

A dose escalating, placebo-controlled phase 1 trial was conducted to test the safety and immunogenicity of a vaccine containing recombinant Plasmodium falciparum apical membrane antigen 1 (AMA1) formulated in Montanide ISA720. Three groups of volunteers were vaccinated intramuscularly with 5 μg, 20 μg or 80 μg of AMA1, respectively, in 0.5 mL of formulation at 0, 3 and 6 months. Anti-AMA1 antibody levels and T cell stimulation indices were measured before and after each vaccination. No vaccine-related serious adverse events were recorded. Most subjects generated a mild to moderate, transient local reaction after the first vaccination. Three subjects developed a local reaction approximately 1..

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