The objective of our Cooperative Center for Human Immunology (CCHI) is to use the analysis of vaccine- induced immunity to influenza as a model for defining adaptive and innate immune mechanisms and antiviral protection in children and younger 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 participating laboratories and provide matched de-identified clinical data for analysis. Centralizing these functions is particularly important for protocols that involve children to allow for the most efficient use of small volume blood samples. 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 and children 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. Randomization codes and 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. Blood, lymph node tissue, aspirates, and tonsils 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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