Multivalent Flavivirus Vaccine Development Using a Flexible Replicating RNA Platform

The project will enable advanced preclinical development of an RNA-based multivalent vaccine for YFV and ZIKV. Pre-clinical immunogenicity and efficacy studies in rodent and NHP models will be used to demonstrate protection of the multivalent product against both pathogens, and may be compared to protective capacity previously demonstrated with a ZIKV monovalent vaccine built on the same platform. Subsequent to efficacy demonstrations, cGMP manufacturing of vaccine components will enable pivotal GLP toxicology studies in rabbits. Finally, a phase 1 clinical trial will demonstrate safety of the vaccine, and, in so doing, will establish the safety of a robust RNA-based platform, which may be subsequently used to rapidly advance additional vaccine candidates, particularly to agents which post a biodefense risk.