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

The Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) is offering a funding opportunity for the translation of advanced HIV-1 vaccine candidates. The grant is intended to move these candidates from pre-clinical studies into various stages of process and product development, and even onto clinical testing.

The grant also covers several other crucial steps, such as technology transfer, preclinical immunogenicity studies and optimization. Process development, analytical assay development, testing, qualification, and validation are also part of this grant's scope. Additionally, the funding will enable small scale pilot or engineering runs and Current Good Manufacturing Practice (CGMP) manufacturing. These activities will be conducted in association with Pharma, Biotech, and Contract Manufacturing Organizations (CMO).

In terms of quality procedures, the grant funds oversight of quality assurance and control, and completion of fill-finish activities. It also supports the aspects of product storage and release, and the generation of a reference standard. The stability testing programs of drug substance and drug product are also included under this grant.

Lastly, the grant covers the costs related to the preparation of Investigational New Drug (IND)-enabling studies and regulatory submission. Ultimately, this funding opportunity aims to provide comprehensive support for all aspects of HIV-1 vaccine development, ensuring efficiency and efficacy in its thorough execution.