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Clinical Core: Core B

临床核心：核心 B

基本信息

批准号：
9246041
负责人：
PONTIANO KALEEBU
金额：
$ 18.47万
依托单位：
DREXEL UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/9246041
关键词：
AIDS Vaccines Adult Affect Africa Antibodies Biological Cells Clinical Clinical Research Code Collaborations Communities Conduct Clinical Trials Data Databases 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 Testing Uganda Vaccines Virus Whole Blood Woman Work clinically relevant co-infection college data management efficacy trial epidemiologic data experience immunogenicity microbiome peripheral blood programs quality assurance response vaccine response

项目摘要

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