This project is designed to prepare a GMP quality investigational RSV vaccine and complete the preclinical, laboratory and long-term product stability studies needed to begin and maintain clinical trials. The Vaccine Research Center (VRC), NIAID is developing a novel prime-boost RSV vaccine strategy directed at prevention of RSV disease. Stable cell lines producing the recombinant protein have been developed and further process, formulation and analytical development is on-going. The recombinant protein being developed is known as DS-Cav1 and is a stabilized pre-fusion RSV-F protein. Stable CHO cell lines have been developed for the production of DS-Cav1 in a GMP environment. Development of a bioreactor-based cell culture process and downstream purification process is in progress. Additionally, formulations are being developed to maintain the product in a stable state for the lifetime of the clinical trials or 2 years at a minimum. Analytical (assay) development is also being performed to allow lot release, characterization and long-term stability testing of the GMP product. After the process is developed, IND-enabling pre-clinical studies will be performed and GMP material produced. Subsequently, an IND will be filed to allow clinical testing of the product in the desired human populations.
