Clinical Core: Core B

临床核心B摘要 临床核心的目标是提供一个集中的丰富的数据和样本存储，来自 年独立资助的使用乙肝疫苗的模拟艾滋病毒疫苗效力试验 乌干达支持U19项目的翻译活动。核心意志的领导力 由UVRI-IAVI艾滋病毒疫苗执行主任诺亚·基瓦努卡博士提供 程序。Kiwanuka博士将由MRC/UVRI主任Pontiano Kaleebu协助 乌干达研究单位兼乌干达病毒研究所(UVRI)副主任，恩德培， 伯纳德·巴加亚博士。领导者在进行临床试验方面有很长的经验， 实验室分析和国际合作，UVRI实验室完全 装备齐全。国际艾滋病疫苗倡议，试验的赞助商，将提供科学 专业知识、支持、技术和质量保证。这些试验是在 由精通临床工作的调查人员进行适当的伦理批准和知情同意， 根据良好的临床实践。社区被告知并支持这些试验， 这既是因为医学研究对其人口的辅助好处，也是因为他们 欣赏这项工作的重要性。临床核心将管理流行病学数据 和在乌干达产生的实验室数据，存储在临床数据库中，并与 财团合作伙伴。这两个试验的样本将使用 LIMS系统，并运往帝国理工学院IAVI人类免疫学实验室(HIL) 伦敦，那里将安全地存储标本。临床核心将评估乙肝病毒滴度， 全血聚合酶链式反应检测亚临床疟疾与肠道感染类型及感染水平 用聚合酶链式反应和显微镜检测蠕虫。(年轻的调查员(Bagaya，Kyosimiire-Lugemwa) 乌干达已被纳入这些项目，并将在该项目中进行一些免疫学检测 容量。)样品的运输将由IAVI HIL管理，该公司运输数千件 每年往返于非洲和其他目的地的标本。数据管理将是 按照最高质量和保密标准进行。实验室技术娴熟 并获得良好的临床实验室操作规范认证，发货过程符合IATA 规章制度。临床研究核心将与参与研究的研究人员密切互动 研究项目和核心完成以下具体目标。

CLINICAL CORE B abstract The goal of the Clinical Core is to provide a central rich store of data and specimens from two independently funded ‘Simulated HIV Vaccine Efficacy Trial’ using Hepatitis B vaccine in Uganda to support the translational activities for the U19 program. Leadership of the Core will be provided by Dr. Noah Kiwanuka, who is Executive Director of the UVRI-IAVI HIV Vaccine Program. Dr. Kiwanuka will be assisted by Pontiano Kaleebu, the Director of the MRC/UVRI Uganda Research Unit and Deputy Director Uganda Virus Research Institute (UVRI), Entebbe, and by Dr. Bernard Bagaya. The leaders have long experience in conduct of clinical trials, laboratory analysis and international collaborations, and the UVRI laboratories are fully equipped. The International AIDS Vaccine Initiative, sponsor of the trials, will provide scientific expertise, and support, technical and quality assurance. The trials have been carried out with appropriate ethical approvals and informed consent, by investigators skilled in clinical work, according to Good Clinical Practices. Communities are informed and supportive of the trials, both because of the ancillary benefits of medical research to their populations and because they appreciate the importance of the work. The Clinical Core will manage the epidemiologic data and laboratory data generated in Uganda, in a clinical database, and share coded data with Consortium partners. Specimens from these two trials will be tracked and managed using a LIMS system and shipped to the IAVI Human Immunology Laboratory (HIL), Imperial College London, which will securely store specimens. The Clinical Core will assess Hepatitis B titers, subclinical malaria by whole blood PCR and the types and infestation level of intestinal helminths by PCR and microscopy. (Young investigators (Bagaya, Kyosimiire-Lugemwa) from Uganda have been included in the Projects, and will carry out some immunologic assays in that capacity.) Shipments of samples will be managed by IAVI HIL, which ships many thousands of specimens to and from Africa and other destinations each year. Data management will be carried out according to highest quality and confidentiality standards. Laboratories are skilled and certified for Good Clinical Laboratory Practices, and shipment processes are per IATA regulations. The Clinical Research Core will interact closely with investigators involved in Research Projects and the Cores to accomplish the following specific aims.