Manufacturing Process development for an inactivated Rotavirus Vaccine using attenuated CDC-9 strain

This project aims to develop and scale up an inactivated rotavirus vaccine (IRV), CDC-9, to address the limitations of current oral rotavirus vaccines (ORVs) in low- and middle-income countries, where reduced efficacy is driven by factors such as malnutrition, enteric co-infections, and interference from maternal antibodies. The IRV, produced using Vero cell cultivation and thermal inactivation to preserve antigen integrity and enhance safety, is administered intramuscularly to elicit stronger and more consistent systemic immunity, thereby improving protection in infants where ORVs underperform. The proposed work includes optimizing upstream and downstream manufacturing processes, increasing production yield, and completing early-phase clinical trials to demonstrate safety and immunogenicity, with the ultimate goal of supporting global immunization efforts and reducing child mortality from severe diarrheal disease.