The objective of this project is to provide a facility for the production and safety testing of vaccine preparations intended for evaluation in the Vaccine, Treatment and Evaluation Units (VTEUs) of the Division of Microbiology and Infectious Diseases (DMID).
The facility will also serve as a repository for specimens generated during DMID-supported Phase I, II, and III clinical trials. Specifically, this facility will accelerate the development of new and improved vaccines of public health importance. The work in this contract encompasses the development and pilot lot production, and related studies, of vaccines appropriate for human clinical trials. With an ever-growing number of NIAID supported clinical vaccine evaluations there is also a growing need for a central facility to systematically store, transport and track and increasing number of clinical specimens that are generated during DMID-supported clinical trials. The capacity to develop and produce a wide range of such candidates will enhance the ability of DMID to meet its expanding needs and better fulfill its mission by promoting and supporting preclinical and clinical research on vaccines that will improve the health of the public. Therefore, this contract will provide the capability for all aspects of development and pilot lot production, including safety testing, of a broad range of vaccine candidates (including viral, bacterial, parasitic and fungal preparations and subtractions consisting of polysaccharides, nucleic acids, lipoproteins, and/or synthetic or purified proteins (either linear or variations of branched multiple antigen preparations) intended for evaluation in humans as experimental vaccines.