Mali International Center for Excellence in Research: Malaria Clinical Research

在马里班古马纳启动了一项议定书，以制定疟疾传播阻断分析和估计配子体携带率(NIAID 11-I-N143号议定书)。阻止蚊子感染疟疾的疫苗有可能成为消灭或根除疟疾的关键工具。这种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业知识，这些专业知识在这种合作中是独一无二的。评估这些疫苗潜在益处的分析需要标准化，并在疟疾暴露人群中进行验证。还需要基线数据来规划传播阻断疫苗的现场试验，预计将于2012年启动。这项研究于2011年7月完成了250名儿童和成年人的登记。参与者将每月接受跟踪，以确定寄生虫携带率。配子体阳性的志愿者将参与蚊子喂食试验(包括直接皮肤喂养和薄膜喂养)，以使用各种实验室方法提供蚊子传染性的数据。2011年8月，戈登研究会议上公布了注册数据和初始喂养实验的结果。 延续BSAM2/Alwater Gel+CPG 7909的1a，b期临床方案。该方案以创新的设计结合了美国和马里成年人的第一阶段研究。在美国剂量增加后，马里的30名志愿者被随机接受研究疫苗或对照组。马里于2010年8月完成了疫苗接种，并在学习日360对志愿者进行了跟踪。最后一次后续访问计划在720学习日进行。初步分析表明，该疫苗具有免疫原性，大多数相关不良事件的严重程度为轻度或中度。非盲目结果将于2011年12月在ASTMH上公布(盲目结果于2010年公布)。 对在马里成人的AMA1-C1/Alwater Gel+/-CPG 7909和马里儿童的顶膜抗原1-结合1(AMA1-C1)/Alwater Gel的第1、2期协议研究下收集的数据进行了额外的分析(简称)。这些方案已与NIAID IRB一起终止，但根据NIAID方案08-I-N064，人类标本的研究使用，数据分析仍在继续。2011年到目前为止，又出版了三份报告这些研究数据的手稿。 马里婴儿的流行病学研究。这项研究共招募了200名婴儿(6周至6个月大)，并对他们进行了一两个疟疾传播季节的跟踪调查。收集了临床疟疾和无症状寄生虫血症的频率的基线数据。正在进行数据分析和手稿准备工作。 临床实验室。该临床实验室于2010年4月通过了美国病理学家学会的认证，并在经过自我检查后于2011年4月重新获得认证。这是西非或北非第一个获得CAP认证的临床实验室。质量保证过程正在进行中，实验室继续为LMIV的研究活动提供关键支持。预计该实验室将过渡到核心设施，以支持MRTC的其他DIR活动。

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.