| Literature DB >> 15811655 |
Allan Saul1, Greg Lawrence, Anthony Allworth, Suzanne Elliott, Karen Anderson, Christine Rzepczyk, Laura B Martin, Darrin Taylor, Damon P Eisen, David O Irving, David Pye, Pauline E Crewther, Anthony N Hodder, Vincent J Murphy, Robin F Anders.
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 microg, 20 microg or 80 microg 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.Entities:
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Year: 2005 PMID： 15811655 DOI： 10.1016/j.vaccine.2004.09.040
Source DB: PubMed Journal: Vaccine ISSN： 0264-410X Impact factor: 3.641