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 project involves the provision of technical immunological support services to the VRC's Immunology Core that result in completion of testing and validation of a universal influenza vaccine assay using unique analytical assays and tools (e.g., automation of cloning process for human monoclonal antibody production;micro-viral neutralization assay and automation) developed by the VRC. Testing and validation will occur on these unique analytical assays and tools, as well as testing correlates between the micro-neutralization assay and the historically used hemagglutination assays, and provision of a validated assay suitable for vaccine licensure. This project will create new positions to support the development, production, testing, and release of vaccines at the VRC NVITAL facility during the tenure of the ARRA funded program. These positions will support universal influenza projects which could be used in a variety of ways to spur advances in health, science, and medicine.
