Journal
VACCINE
Volume 35, Issue 45, Pages 6218-6227Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2017.09.027
Keywords
Malaria; Plasmodium falciparum; Apical membrane antigen 1; Vaccine trial; Immunogenicity; Adjuvants; Safety
Categories
Funding
- European Vaccine Initiative (EVI)
- Dutch Directorate for International Collaboration
- Irish Aid (Department of Foreign Affairs and Trade, Ireland)
- Institut national de la sante et de la recherche medicale (Inserm)
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Background: Plasmodium falciparum Apical Membrane Antigen 1 Diversity Covering (PfAMA1-DiCo) candidate vaccine is a formulation of three recombinant variants of AMA1 designed to provide broader protection against parasites with varying AMA1 sequences. Methods: In this staggered phase Ia/Ib randomized, double blind trial, healthy French adults received AMA1-DiCo with either Alhydrogel (R) (n = 15) or GLA-SE (n = 15). Following a safety assessment in French volunteers, GLA-SE was chosen for the phase Ib trial where healthy Burkinabe adults received either AMA1-DiCo/GLA-SE (n = 18) or placebo (n = 18). AMA1-DiCo (50 mu g) was administered intramuscularly at baseline, Week 4 and 26. Results: AMAI-DiCo was safe, well tolerated either with Alhydrogel or GLA-SE. In European volunteers, the ratios of IgG increase from baseline were about 100 fold in Alhydrogel (R) group and 200-300 fold in GLA-SE group for the three antigens. In African volunteers, immunization resulted in IgG levels exceeding those observed for the European volunteers with a 4-fold increase. DiCo-specific IgG remained higher 26 weeks after the third immunization than at baseline in both European and African volunteers. Induced antibodies were reactive against whole parasite derived from different strains. Conclusion: AMA1-DiCo vaccine was safe and immunogenic whatever the adjuvant although GLA-SE appeared more potent than Alhydrogel (R) at inducing IgG responses. (C) 2017 Published by Elsevier Ltd.
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