Clinical Core

临床核心

• 批准号: 10419277
• 负责人: Kari C. Nadeau
• 金额: $ 30.97万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-07 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10419277
• 关键词: Ablation; Address; Adherence; Adjuvant; Adult; Africa; Algorithms; Allergic Disease; Allergic Reaction; Antibiotics; Antigens; Aspirate substance; Automobile Driving; Award; B-Lymphocytes; Bioinformatics; Biological Assay; Biological Markers; Blood; Bone Marrow; COVID-19 vaccine; Cataloging; Cells; Clinical; Clinical Immunology; Clinical Investigator; Clinical Research; Clinical Trials; Collaborations; Communication; Computer Models; Cytometry; Data; Data Analyses; Data Security; Data Storage and Retrieval; Databases; Development; Ensure; Exposure to; Fine needle aspiration biopsy; Goals; Good Clinical Practice; Guidelines; Hospitals; Human; Human Resources; Immune; Immune response; Immunity; Immunologic Monitoring; Immunology; Individual; Influenza; Informatics; Infrastructure; Institutional Review Boards; Investigation; Longitudinal Studies; Measures; Messenger RNA; Molecular Profiling; Monitor; National Institute of Allergy and Infectious Disease; Natural Immunity; Nature; Performance; Pfizer-BioNTech COVID-19 vaccine; Plasma; Population; Practice Guidelines; Predisposition; Procedures; Process; Protocols documentation; Quality Control; RNA vaccine; Rabies; Recombinants; Reporting; Research; Research Personnel; Research Project Grants; Role; Sampling; Saponins; Services; South African; Special Population; Specimen; Standardization; System; T cell response; T-cell receptor repertoire; Technology; Time; Training; Translational Research; United States National Institutes of Health; Update; Vaccination; Vaccines; Validation; Work; adaptive immunity; antigen-specific T cells; base; biological systems; cytokine; data integration; data management; data submission; epigenomics; expectation; human subject; human subject protection; improved; influenza virus vaccine; metabolomics; microbiome; microbiota; multiple omics; new technology; novel; public database; recruit; response; sample collection; search engine; seasonal influenza; single cell analysis; transcriptomics; vaccine development; vaccinology

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

摘要：临床核心