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 was completed. Additionally, stable formulations were 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 was competed to allow lot release, characterization and long-term stability testing of the GMP product. GMP materials were prepared and used in IND enabling animal studies and clinical studies. Final data for the entire project is pending.
