Mali International Center for Excellence in Research: Malaria Clinical Research

点击翻译按钮获取中文摘要

Initiation of a Phase 1a,b clinical protocol for BSAM2/Alhydrogel+CPG 7909. This protocol combines Phase 1 studies in US and Mali adults in an innovative design. After dose escalation in the US, 30 volunteers in Mali were randomized to receive either the study vaccine or the comparator. Vaccinations have been completed and analysis of safety and immunogenicity results are ongoing. Results will be presented at ASTMH in November 2010. Initiation of an immunoepidemiologic study in pregnant women and young children in Ouelessebougou. After site preparation, recruitment and training of staff, outfitting of a research laboratory space, and implementation of a new CRF and data management system, enrollment for this study began in August, 2009. Children from the village and hospital will be recruited first, with enrollment of pregnant women and their infants to follow. 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. The protocol was terminated in July 2009 but analyses have continued under Protocol NIAID protocol 08-I-N064, Research Use of Human Specimens. Results have been published. 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 (Dongubougou 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 have been published. This protocol was terminated with the NIAID IRB in April 2009 but analysis of data has continued under NIAID protocol 08-I-N064, Research Use of Human Specimens and additional manuscripts 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 were followed through December 2009. 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 were presented at ASTMH in 2008 and in 2009. Analysis of data and preparation of manuscripts is ongoing. Laboratory. After two years of extensive preparation and quality improvement the clinical lab achieved certification by the College of American Pathologists in April, 2010. This is the first clinical lab in West or North Africa to achieve CAP certification. The process of gaining certification will be presented at ASTMH in November 2010.