Mali International Center for Excellence in Research: Malaria Clinical Research

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Completion of a Phase 1,2 study of Apical Membrane Antigen 1-Combination 1 (AMA1-C1)/Alhydrogel in Malian children. This double blind, randomized clinical trial started in 2006 and completed clinical follow up in January 2008. A total of 336 children were enrolled in two sites (Doneguebougou and Bancoumana) and followed through two malaria transmission seasons to assess the safety and biologic impact on falciparum malaria of this blood stage malaria vaccine candidate. Results through the first transmission season were presented at the American Society of Tropical Medicine and Hygiene (ASTMH) in November 2007 and have since been published in the journal Vaccine. Initiation and completion of a Phase 1 study of AMA1-C1/Alhydrogel +/- CPG 7909 in Malian adults. This was a double blind, randomized clinical trial of AMA1-C1/Alhydrogel, with the novel adjuvant CPG 7909, which has been shown in a previous US trial to enhance antibody responses to vaccination 10-14 fold. This was the first use of CPG 7909 in a malaria endemic population. Vaccinations began in October 2007 and follow up was completed in May 2008. Results were presented at the ASTMH in November 2008 and have been submitted for publication. Epidemiologic study in Malian infants. This study enrolled 100 infants (aged 6 weeks to 6 months) in August 2007 and followed them through a malaria transmission season to January 2008. Another 100 infants were enrolled in July 2008, and will be followed through two malaria transmission seasons. Data obtained will be used to establish baseline parameters and sample size estimates for anticipated Phase 2 trials of malaria vaccine candidates in Malian infants. Results from the first cohort were presented at ASTMH in November 2008. Laboratory. Clinical and immunologic lab staffing, equipment, and procedures were comprehensively assessed and strengthened. Results are now continuously validated, and quality of data produced by the lab is comparable to that produced at the MIV. The clinical lab is moving forward to certification by the College of American Pathologists.