Clinical Core: Core B

临床核心B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.