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Hi,
I'm looking for general information on the preclinical requirements (US, CBER) in support of first in human studies for therapeutic vaccine development. What types of nonclinical studies are required to support first in human studies (eg Adeno-vectored therapeutic vaccine). Primarily looking at the differences compared to what's required for small molecules. I know characterization of immunogenicity is important, but what kinds of studies are required (animal species, types of studies, length of studies, models/). And what additional safety parameters need to be studied in the first in human study of a novel therapeutic vaccine? Trying to get an idea of the overall preIND nonclinical/clinical package compared to small molecule.
Thank you.