The IPCAVD Program Coordination and Product Development Core (CoreA) will serve as the primary coordinating center for the integration and advancement of all Projects and Cores; provide biostatistical support for IPCAVD research programs; and have primary responsibility for interacting with NIH program staff and our External Steering Committee to ensure that IPCAVD timelines and milestones are accomplished as responsibly and expeditiously as possible. Core A will be responsible for interactions with our collaborating vaccine manufacturer, Bavarian Nordic, as well as with our collaborating consultants at SRI International who will conduct the majority of our pre-clinical vaccine safety studies. With the assistance of SRI International, Core A will work to ensure effective preparation and timely processing and filing of FDA Investigational New Drug (IND) applications in support of the improved MVA-HIV vaccines to be studied in our proposed Phase I clinical trial. Core Astaff will coordinate the pro-clinical macaque immunogenicity studies to be conducted at the Yerkes Primate Research Center in support of our IND filings. We intend to simultaneously manufacture 2 different MVA vaccine candidates and simultaneously file 2 separate IND applications to enable conduct of a comparative Phase I trial in healthy volunteers. Core A staff will be also responsible for ensuring that all IPCAVD studies are performed in accordance with all prevailing regulations for the conduct of responsible and ethical research.
