Integrated Preclinical / Clinical AIDS Vaccine Development Program (IPCAVD) (U19 Clinical Trial Not Allowed)

The purpose of this Funding Opportunity Announcement (FOA) is to support translation of advanced HIV-1 vaccine candidates from pre-clinical studies through different phases of process and product development, Current Good Manufacturing Practice (CGMP) manufacturing and regulatory filing to the point of clinical testing. The FOA will support technology transfer, preclinical immunogenicity and optimization studies, process development, analytical assay development, qualification, validation, testing, small scale pilot or engineering runs, CGMP manufacture in partnership with Pharma/Biotech/Contract Manufacturing Organizations (CMO), quality assurance/quality control oversight, fill-finish activities, product release and storage, generation of reference standard, drug substance and drug product stability testing programs, Investigational New Drug (IND)-enabling studies, regulatory submission preparation.