Core A (Administrative Core) will provide all the logistic, scientific, managerial, and financial oversight to facilitate and to coordinate the studies described in this IPCAVD program. Centralized administration is critical for efficient project management and coordination. The Administrative Core will ensure that the preclinical studies (Project 1), clinical studies (Project 2), and manufacturing program (Project 3) adhere to the timelines and deliverables described in those sections of this IPCAVD program. The Administrative Core will organize weekly conference calls and regular in-person meetings among the investigators, interface with HVTN clinical sites, maintain regulatory approvals for all preclinical and clinical studies, provide fiscal and logistic oversight, manage subcontracts, and coordinate meetings with the Scientific Advisory Committee and DAIDS Program Officials. This detailed administration and management structure will ensure that all the studies remain focused on the overall objective to advance the novel heterologous rAd prime-boost HIV-1 vaccine into phase 1 and phase 2a clinical trials. To accomplish these goals, we propose the following four Specific Aims: 1. To coordinate communications, interactions, and operations among investigators, projects, and collaborators to facilitate the overall progress and goals of this IPCAVD program; 2. To ensure and to maintain regulatory compliance for all preclinical and clinical studies; 3. To provide detailed financial oversight and management for projects and subcontracts;and 4. To coordinate meetings with the Scientific Advisory Committee and DAIDS Program Officials.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Program--Cooperative Agreements (U19)
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Special Emphasis Panel (ZAI1-CCH-A)
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Beth Israel Deaconess Medical Center
United States
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