The Clinical Immunology Services Core will serve all of the projects in the CCHI. It is at the center of all of the activities in the human immunology clinical trials. The major functions of the core are: Clinical and regulatory support for all of the scientific studies on the samples collected from human clinical immunology trials conducted under the auspices of these projects. The Core will support the consent for the scientific use of and the regulatory requirements associated with the use of human clinical samples that have been collected under previously conducted IRB approved protocols at The Rockefeller University Hospital. These samples are from the seven already IRB approved clinical protocols of experimental vaccines and vaccine adjuvants. The Core will also provide clinical and regulatory support for the conduct of ongoing and planned clinical trials of licensed influenza, pneumococcal, meningicoccal, and hepatitis B vaccines proposed in Projects 1 and 4. The Core will support all of the regulatory, human subjects protection, and clinical execution of these clinical trials. In addition the Clinical Immunology Services Core will also complete all of the data entry and management associated with these proposed protocols.
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