African Swine Fever Modified Live Vaccine Candidates: Transitioning from Discovery to Product Development through Harmonized Standards and Guidelines.

Although highly significant at the time, this study, and subsequent studies [ 47 , 48 ] used proof-of-concept clinical study designs (e.g., relatively high vaccine doses, multiple immunizations, unsafe adjuvants, ASFV low challenge doses) impractical for direct transition to a regulatory product development program.

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