Malaria Vaccine Trials in Mali

马里的疟疾疫苗试验

• 批准号: 6960293
• 负责人: CHRISTOPHER V. PLOWE
• 金额: $ 65.79万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6960293
• 关键词: clinical research; clinical trials; cooperative study; human subject; malaria vaccines; vaccine evaluation

DESCRIPTION (provided by applicant): Malaria is the leading parasitic infectious disease in the tropics. The heaviest burden is borne by children in Africa, where more than 2 million succumb to this dreaded disease every year. The critical pathway for vaccine development requires the conduct of safety (Phase 1A) vaccine trials in the United States, followed by safety and efficacy (Phase1B/ 2B) vaccine trials at sites where malaria transmission is endemic. Two projects are organized around the central theme of developing a safe and effective malaria vaccine to prevent disease and death due to falciparum malaria in African children. Interventional clinical trials of a malaria vaccine candidate will be conducted in Project 1, and samples from Project 1 will be analyzed in Project 2 to address important questions that will inform the vaccine development and testing process. Administrative and biostatistical cores will support both projects. Our other main objective is to provide research experience for U.S. and Malian scientists and to strengthen the already strong linkages between U.S. and Malian investigators to enhance the independent research capacity of the University of Bamako, Mali. The majority of the proposed research will be conducted in Mali, at the Bandiagara Malaria Project clinical trials site and at the Malaria Research and Training Center at the University of Bamako. The U.S. and Malian investigators will collaborate closely in the design, implementation, monitoring, and management of the research.

描述（由申请人提供）：疟疾是热带地区领先的寄生传染病。最重的负担是由非洲儿童承担的，每年有超过200万人屈服于这种可怕的疾病。疫苗开发的关键途径需要在美国进行安全性（第1A期）疫苗试验，然后在疟疾传播的地方进行安全性和功效（阶段1b/ 2b）疫苗试验。 围绕开发安全有效的疟疾疫苗的中心主题组织了两个项目，以防止因非洲儿童恶性疟疾而导致的疾病和死亡。将在项目1中进行疟疾疫苗的介入临床试验，项目1中将分析项目1的样本，以解决将为疫苗开发和测试过程提供信息的重要问题。行政和生物统计核心将支持这两个项目。我们的另一个主要目的是为美国和马里科学家提供研究经验，并加强美国和马里研究人员之间已经有着牢固的联系，以增强马里巴里巴马科大学的独立研究能力。 拟议的大多数研究将在马里，Bandiagara Malaria Project临床试验地点以及巴马科大学的疟疾研究与培训中心进行。美国和马里的调查人员将在研究，实施，监视和管理方面密切合作。