Clinical Core: Core B

临床核心：核心 B

• 批准号: 10224803
• 负责人: PONTIANO KALEEBU
• 金额: $ 2.41万
• 依托单位: DREXEL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-10 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10224803
• 关键词: AIDS Vaccines; Adult; Affect; Africa; Biological; Cells; Clinical; Clinical Research; Code; Collaborations; Communities; Conduct Clinical Trials; Data; Data Store; Destinations; Diet; Ethics; Fishes; Funding; Gene Expression; Goals; Good Clinical Practice; HIV vaccine; Helminths; Hepatitis B; Hepatitis B Vaccines; Human; Immune; Immune response; Immunology; Immunology procedure; Infection; Informed Consent; International; International AIDS; Intervention; Intestines; Knowledge; Laboratories; Leadership; Liver diseases; London; Malaria; Medical Research; Microscopy; Parasites; Phenotype; Population; Process; Regulation; Research; Research Institute; Research Personnel; Research Project Grants; Sampling; Science; Scientist; Secure; Ships; Specimen; System; Uganda; Vaccines; Virus; Whole Blood; Woman; Work; antibody test; clinical database; clinically relevant; co-infection; college; data management; efficacy trial; epidemiologic data; experience; immunogenicity; microbiome; peripheral blood; programs; quality assurance; response; vaccine response

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.

临床核心 B 摘要 临床核心的目标是提供来自两个中心的丰富数据和样本的中央存储 独立资助的使用乙型肝炎疫苗的“模拟艾滋病毒疫苗功效试验” 乌干达支持 U19 项目的转化活动。核心领导力将 由 UVRI-IAVI HIV 疫苗执行主任 Noah Kiwanuka 博士提供 程序。 Kiwanuka 博士将得到 MRC/UVRI 主任 Pontiano Kaleebu 的协助 乌干达研究单位兼副主任乌干达病毒研究所（UVRI），恩德培， 伯纳德·巴加亚博士。领导者具有长期进行临床试验的经验， 实验室分析和国际合作，UVRI 实验室完全 配备。试验赞助商国际艾滋病疫苗倡议将提供科学依据 专业知识、支持、技术和质量保证。试验已进行 由临床工作熟练的研究者进行适当的伦理批准和知情同意， 根据良好临床实践。社区了解并支持试验， 既因为医学研究给他们的人民带来了附带好处，也因为他们 认识到工作的重要性。临床核心将管理流行病学数据 和在乌干达生成的临床数据库中的实验室数据，并与以下人员共享编码数据： 财团伙伴。这两项试验的样本将使用 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，将安全地储存标本。临床核心将评估乙型肝炎滴度， 全血PCR检测亚临床疟疾及肠道疟原虫类型和侵染水平 通过 PCR 和显微镜检查蠕虫。 （年轻调查员（Bagaya，Kyosimiire-Lugemwa）来自 乌干达已被纳入该项目，并将在该项目中进行一些免疫学测定 ）样品的运输将由 IAVI HIL 管理，该公司运输了数千个样品 每年都有标本往返于非洲和其他目的地。数据管理将 根据最高质量和保密标准进行。实验室技术精湛 并获得良好临床实验室规范认证，运输流程符合 IATA 标准 法规。临床研究核心将与参与的研究人员密切互动 研究项目和核心以实现以下具体目标。