Mali International Center for Excellence in Research: Malaria Clinical Research

马里儿童顶膜抗原1-组合1(AMA1-C1)/Alwater Gel的1，2期研究完成。这项双盲随机临床试验始于2006年，于2008年1月完成临床随访。共有336名儿童在两个地点(DongueBougou和Bancoumana)登记，并在两个疟疾传播季节进行跟踪，以评估这种血液期疟疾疫苗候选疫苗的安全性和对恶性疟疾的生物影响。2007年11月在美国热带医学和卫生学会(ASTMH)上公布了第一个传播季节的结果，此后发表在《疫苗》杂志上。 在马里成人中启动和完成AMA1-C1/Alwater Gel+/-CPG 7909的第一阶段研究。这是一项AMA1-C1/Alwater Gel的双盲随机临床试验，使用新型佐剂CPG7909，美国之前的一项试验表明，这种佐剂可以将疫苗接种后的抗体反应提高10-14倍。这是CPG7909第一次在疟疾流行人群中使用。2007年10月开始接种疫苗，2008年5月完成后续工作。结果已于2008年11月在ASTMH上提交，并已提交发表。 马里婴儿的流行病学研究。这项研究于2007年8月招募了100名婴儿(6周至6个月大)，并在疟疾传播季节对他们进行跟踪，直至2008年1月。2008年7月又登记了100名婴儿，并将在两个疟疾传播季节对其进行跟踪。获得的数据将用于确定马里婴儿疟疾疫苗候选第二阶段预期试验的基线参数和样本量估计。第一个队列的结果于2008年11月在ASTMH上公布。 实验室。全面评估和加强了临床和免疫学实验室的人员配备、设备和程序。结果现在不断得到验证，实验室产生的数据质量与MIV产生的数据质量相当。该临床实验室正在争取通过美国病理学家学会的认证。

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.