A human phase 1 vaccine clinical trial of the Plasmodium falciparum malaria vaccine candidate apical membrane antigen 1 in Montanide ISA720 adjuvant
Details
Publication Year 2005-04-27, Volume 23, Issue #23, Page 3076-3083
Journal Title
VACCINE
Publication Type
Journal Article
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 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.
Publisher
ELSEVIER SCI LTD
Keywords
APICAL MEMBRANE ANTIGEN-1; BLOOD-STAGE MALARIA; PAPUA-NEW-GUINEA; AMA-1; IMMUNOGENICITY; LOCALIZATION; IMMUNIZATION; EXPRESSION; DIVERSITY; INFECTION
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Creation Date: 2005-04-27 12:00:00
Last Modified: 0001-01-01 12:00:00
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