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标本存储， 独立资助的“模拟艾滋病毒疫苗效力试验”，使用B型肝炎疫苗， 乌干达支持U19计划的翻译活动。核心的领导力将 由UVRI-IAVI HIV疫苗执行主任Noah Kiwanuka博士提供 程序. Kiwanuka博士将由MRC/UVRI主任Pontiano Kaleebu协助 乌干达病毒研究所乌干达研究股和副主任，恩德培， 和伯纳德·巴加亚博士领导者在临床试验方面有长期的经验， 实验室分析和国际合作，UVRI实验室完全 搭载国际艾滋病疫苗倡议组织是这些试验的发起者， 专业知识、支持、技术和质量保证。试验已经进行， 适当的伦理批准和知情同意，由熟练的临床工作的研究者， 根据良好的临床实践。社区了解并支持审判， 这既是因为医学研究给他们的人口带来的附带好处，也是因为他们 认识到工作的重要性。临床中心将管理流行病学数据 和实验室数据，在临床数据库中，并与 财团伙伴。这两项试验的标本将使用 LIMS系统，并运送至帝国理工学院IAVI人类免疫学实验室（HIL） 伦敦，它将安全地储存标本。临床中心将评估B型肝炎滴度， 全血PCR检测亚临床疟疾与肠道寄生虫类型及感染水平 蠕虫通过PCR和显微镜。（来自Bagaya、Kyosimiire-Lugemwa的年轻调查员） 乌干达已被列入项目，并将在该项目中进行一些免疫测定， 能力。）样本的运输将由IAVI HIL管理，该公司将运送数千份样本， 每年往返非洲和其他目的地的标本。数据管理部门将 按照最高的质量和保密标准进行。实验室技术熟练 并通过了药物临床试验质量管理规范认证，运输过程符合IATA要求 规定临床研究中心将与参与以下研究的研究者密切互动： 研究项目和核心，以实现以下具体目标。

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.