Clinical Core

NIH Pandemic-Era Grants

Pandemic Era Grants

2024

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Principal Investigator: R. Sharon Chinthrajah
Organization: STANFORD UNIVERSITY
Fiscal Year: 2024
Award: $312,716
Funding agency: National Institute of Allergy and Infectious Diseases

PROJECT SUMMARY 
The objective of our Cooperative Center for Human Immunology (CCHI) is to use the analysis of 
vaccine induced immunity and natural infections to Influenza and Sars COV-2 as a model for defining 
adaptive and innate immune mechanisms and antiviral protection in adults. The Clinical Core will be 
responsible for coordinating protocol design and implementation to maximize opportunities for parallel 
evaluations across the research projects and scientific cores, obtaining human subjects approvals, 
and creating and managing the centralized database to record clinical data. The Clinical Core will 
coordinate distribution of relevant specimens to the HIMC Core and provide matched de-identified 
clinical data for analysis. As the work proceeds, the Clinical Core database will facilitate comparative 
analyses of results obtained from the individual research projects. One of the goals of the Clinical 
Core is to make the necessary IRB submissions for clinical studies, recruit and enroll adults into the 
protocols, assure that participant rights are respected throughout the duration of their trial participation 
and provide follow-up to assure collection of complete sets of data from all subjects. Participant 
reimbursement payments will be provided by the core. We will provide centralized clinical data 
management for research projects and other cores using an electronic database with electronic data 
entry and implement a quality management plan to assure data integrity. These data will then be made 
available to the research projects and scientific cores for final data analysis. Biospecimens (blood) 
and clinical data will be collected by the Clinical Core staff according to the specifications of each 
clinical study protocol and delivered either to the CTRU laboratory or directly to research project staff.

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