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

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...

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Bibliographic Details
Published in:	Vaccine 2005-04, Vol.23 (23), p.3076-3083
Main Authors:	Saul, Allan, Lawrence, Greg, Allworth, Anthony, Elliott, Suzanne, Anderson, Karen, Rzepczyk, Christine, Martin, Laura B., Taylor, Darrin, Eisen, Damon P., Irving, David O., Pye, David, Crewther, Pauline E., Hodder, Anthony N., Murphy, Vincent J., Anders, Robin F.
Format:	Article
Language:	eng
Subjects:	Adjuvants, Immunologic - administration & dosage AMA1 Animals Antibodies, Protozoan - blood Antigens, Protozoan - immunology Applied microbiology Biological and medical sciences Female Fundamental and applied biological sciences. Psychology Guinea Pigs Human protozoal diseases Humans Infectious diseases Malaria Malaria Vaccines - adverse effects Malaria Vaccines - immunology Male Mannitol - administration & dosage Mannitol - analogs & derivatives Medical sciences Membrane Proteins - immunology Mice Microbiology Oleic Acids - administration & dosage P. falciparum Parasitic diseases Phase 1 vaccine trial Plasmodium falciparum Plasmodium falciparum - immunology Protozoal diseases Protozoan Proteins - immunology Single-Blind Method T-Lymphocytes - immunology Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
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Summary:	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 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.
ISSN:	0264-410X 1873-2518