The Vaccine Research Center (VRC) is dedicated to translating basic science knowledge into clinical vaccine products. This requires the ability to carry out basic research, construct new vaccine products, perform preclinical research and evaluate candidate vaccines in human studies. To conduct human clinical trials, the VRC has established the infrastructure to produce vaccine products using good manufacturing practices, and to manage regulatory issues related to human trials. The VRC's Vaccine Pilot Plant was specifically developed to rapidly translate research into vaccine products for clinical trials. Activities related to this project include: - Development of optimized expression vectors for HA and NAs - Generation of research-grade and pre-GMP adenoviral vectors using adenoviral vector technology - Contracting with regulatory experts for guidance in the development of vaccines - Pre-clinical testing of vaccine components, possibly including toxicology, biodistribution, and other studies required for support of INDs - Development of assays and processes for support of alternate adenoviral vector production of generated vectors This project will create new positions to support the development, production, testing, and release of vaccines at the VRC Vaccine Pilot Plant during the tenure of the ARRA funded program. In addition, the universal flu program, if successful, has the potential to change the paradigm for influenza vaccination and create a new highly successful vaccine. Licensure of a universal flu vaccine could create significant new jobs in new or existing companies who license the vaccine. In the development of the program, greater scientific understanding of influenza immunology will be generated which can be applied to other vaccine development programs. For example, if electroporation increases the immune response, that could provide critical new knowledge to vaccine research in other infectious diseases.
