Mali International Center for Excellence in Research: Malaria Clinical Research

在马里儿童中完成根尖膜抗原1-组合1（AMA 1-C1）/铝凝胶的1、2期研究。 该双盲、随机临床试验于2006年开始，并于2008年1月完成临床随访。 在两个地点（Doneguebougou和Becommana）共招募了336名儿童，并跟踪了两个疟疾传播季节，以评估这种血液阶段疟疾候选疫苗的安全性和对恶性疟疾的生物学影响。 第一个传播季节的结果于2007年11月在美国热带医学和卫生学会（ASTMH）上发表，并发表在《疫苗》杂志上。 在马里成人中启动并完成AMA 1-C1/Alhydrogel +/- CPG 7909的I期研究。 这是一项AMA 1-C1/Alhydrogel的双盲、随机临床试验，使用新型佐剂CPG 7909，其在之前的美国试验中显示可增强对疫苗接种的抗体应答10-14倍。 这是CPG 7909首次用于疟疾流行人群。 疫苗接种于2007年10月开始，后续行动于2008年5月完成。 研究结果于2008年11月在ASTMH上公布，并已提交出版。 马里婴儿流行病学研究。 这项研究于2007年8月招募了100名婴儿（年龄为6周到6个月），并对他们进行了疟疾传播季节至2008年1月的随访。 2008年7月，又有100名婴儿登记，并将在两个疟疾传播季节对其进行跟踪。 所获得的数据将用于为预期的在马里婴儿中进行的疟疾候选疫苗2期试验确定基线参数和样本量估计。2008年11月，在ASTMH上展示了第一个队列的结果。 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。临床实验室正在向美国病理学家学院的认证迈进。

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.