Clinical Core

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1 ABSTRACT – Clinical Core 2 The Clinical Core of the Stanford HIPC U19 will provide state-of-the-art clinical and biospecimen support for all 3 the research projects, the Immune Monitoring and the Data Management and Analysis Cores, as well as the 4 expertise, facilities, personnel, procedures and processes for the implementation and conduct of the proposed 5 clinical projects. The Clinical Core will provide and update processes and training for clinical investigators and 6 staff; organize, implement, monitor and work to improve clinical project performance; and conduct quality control 7 and corrective action and handle protocol deviations (if needed), including assuring adherence to milestones, 8 project performance expectations, standardized approach in the recruitment and clinical characterization, 9 appropriate human subject protection measures and clinical Good Practice Guidelines. The Clinical Core will 10 provide the clinical research units which include the infrastructure for longitudinal studies: recruitment, retention, 11 data entry and data management, quality review, sample collection (blood, fine needle aspiration (FNA) and 12 bone marrow (BM) aspirates) processing, isolation and cataloging of various specimen types and will oversee 13 all regulatory-related documents and IRB compliant research. The Clinical Core will coordinate clinical 14 biospecimen storage informatics, connecting clinical, biospecimen management, and assay pipelines into a 15 cutting-edge search engine and analysis platform for clinical and translational research. The Clinical Core will 16 be led by Dr. Kari Nadeau with Associate Director Dr. Nadine Rouphael, Dr. Long at UCSF, and Drs. Madhi and 17 Nunez at hospitals in S. Africa. The Clinical Core will work closely with the other cores and projects to enable 18 the functional analysis of any samples with cutting-edge technologies. Drs. Nadeau, Rouphael, Long, Madhi, 19 and Nunez and their teams have the expertise to be able to comprehensively serve as the Clinical Core 20 personnel since they have been successful in other NIH related consortium studies, in performing Clinical Core 21 duties for other immunology clinical studies, and have worked with Drs. Pulendran, Davis, Maecker, Khatri and 22 Boyd for over 15 years. The Core Leader will represent the HIPC center in a HIPC Clinical Sub-Committee that 23 will operate under the HIPC Coordinating Center to promote cross-HIPC collaboration including sharing SOPs, 24 documents, and samples as appropriate. The Clinical Core proposes the following aims: (1) To perform clinical 25 studies with COVID-19 vaccines, and on the impact of the microbiome on rabies vaccination, to provide clinical 26 data and samples to accomplish the scientific goals of the research projects; (2) Establish and maintain 27 personnel training, procedures, and processes to provide core clinical support; and (3) Establish and maintain 28 protocol milestones, performance guidelines, communication strategies, and compliance in clinical studies and 29 sample collection. In summary, the Clinical Core will leverage state-of-the-art biospecimen support services and 30 will coordinate all operational and regulatory aspects of research for the HIPC U19 projects. 31