Clinical Research Core

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CORE B DESCRIPTION: The goal of the Clinical Research Core of the proposed IPCAVD Program is to conduct all studies involving human subjects within the Program: a phase I clinical trial of the safety, tolerability and immunogenicity of innovative recombinant modified vaccinia Ankara (MVA) multiclade, multigene HIV-1 vaccines and two exploratory studies of microdermabrasion of the skin in humans to access epidermal antigen presenting cells for enhanced immunogenicity and safer administration of HIV vaccines. The Clinical Research Core will ensure that all clinical research activities within this IPCAVD Program are conducted according to the highest standards for safe and ethical conduct of research involving human subjects and in keeping with GCP, NIH and FDA requirements and guidelines. The Core will facilitate the clinical aspects of the phase I vaccine trial and microdermabrasion studies, prepare Institutional Review Board applications and informed consent documents, recruit study volunteers, obtain informed consent, screen potential volunteers for their suitability for specific studies, administer study vaccines, obtain appropriate clinical specimens for immunologic studies, and monitor study volunteers to maximize their safety. The Clinical Research Core will interact closely with investigators involved in individual research Projects 1-3, the Project Coordination and Product Development Core, and the Immunology Core to ensure that a highly interactive and effective bridge is established between basic, non-human primate and clinical research activities. In addition, the Core will ensure that all collaborating investigators receive education in appropriate standards for protection of human subjects involved in research studies.