Journal
VACCINE
Volume 23, Issue 23, Pages 3076-3083Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2004.09.040
Keywords
AMA1; P. falciparum; phase 1 vaccine trial
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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 mu g, 20 mu g or 80 mu g 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 10 days following vaccination. Six of the 29 subjects seroconverted. Only one of these developed a high antibody titre. However, the interpretation of this trial was compromised by a loss of potency of the formulated vaccine during the course of the study. (c) 2005 Published by Elsevier Ltd.
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