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.

Project Start
Project End
Budget Start
Budget End
Support Year
4
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Niaid Extramural Activities
Department
Type
DUNS #
City
State
Country
Zip Code