Mali International Center for Excellence in Research: Malaria Clinical Research

在马里的班库马纳启动一项开发疟疾传播阻断测定和估计配子体携带率的方案（NIAID方案11-I-N143）。阻断疟疾在蚊子中的传染性的疫苗有可能成为消除或根除疟疾的关键工具。这类疫苗的临床开发将需要疫苗学、寄生虫学和昆虫学方面的专门知识，而这在此次合作中是独一无二的。估计这些疫苗潜在益处的测定方法需要标准化，并在疟疾暴露人群中得到验证。还需要基线数据来规划一种传播阻断疫苗的实地试验，该试验预计将于2012年启动。该研究于2011年7月完成了250名儿童和成人的登记。每个月对参与者进行随访，以确定寄生虫携带率。配子体阳性志愿者将参加蚊子摄食试验（直接皮肤摄食和膜摄食），利用各种实验室方法提供蚊子传染性的数据。2011年8月，在戈登研究会议（Gordon Research Conference）上发表了入组数据和初步喂养实验结果。

Initiation of a protocol to develop malaria transmission blocking assays and to estimate gametocyte carriage rates in Bancoumana, Mali (NIAID Protocol 11-I-N143). Vaccines which block infectivity of malaria in mosquitoes have the potential to be critical tools in the drive to eliminate or eradicate malaria. Clinical development of such vaccines will require expertise in vaccinology, parasitology, and entomology, uniquely available in this collaboration. Assays to estimate the potential benefit of these vaccines need to be standardized and validated in malaria exposed populations. Baseline data is also needed to plan for a field trial of a transmission blocking vaccine, expected to be initiated in 2012. The study completed enrollment of 250 children and adults in July 2011. Participants will be followed monthly to determine parasite carriage rates. Gametocyte positive volunteers will participate in mosquito feeding assays (both direct skin feeds and membrane feeds) to provide data on mosquito infectivity using various laboratory methods. Enrollment data and the results of initial feeding experiments were presented at the Gordon Research Conference in August, 2011. Continuation 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 were completed in Mali in August 2010 and volunteers have been followed through Study Day 360. The last follow up visit is scheduled for Study Day 720. Preliminary analysis shows the vaccine is immunogenic, with most related adverse events mild or moderate in severity. Unblinded results will be presented at ASTMH in December 2011 (blinded results were presented in 2010). Additional analysis of data collected under protocols Phase 1 study of AMA1-C1/Alhydrogel +/- CPG 7909 in Malian adults and Phase 1,2 study of Apical Membrane Antigen 1-Combination 1 (AMA1-C1)/Alhydrogel in Malian children (short titles). These protocols have been terminated with the NIAID IRB but analysis of data has continued under NIAID protocol 08-I-N064, Research Use of Human Specimens. Three additional manuscripts reporting data from these studies have been published thus far in 2011. Epidemiologic study in Malian infants. This study enrolled a total of 200 infants (aged 6 weeks to 6 months) and followed them through one or two malaria transmission seasons. Baseline data was collected on the frequency of clinical malaria and asymptomatic parasitemia. Analysis of data and preparation of manuscripts is ongoing. Clinical Laboratory. The clinical lab achieved certification by the College of American Pathologists in April, 2010, and was re-certified in April 2011 after a self-inspection. This is the first clinical lab in West or North Africa to achieve CAP certification. Quality assurance processes are ongoing, and the lab continues to provide critical support for study activities for LMIV. It is expected that the lab will transition to a core facility to support other DIR activities at MRTC.