The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency — making important discoveries that improve health and save lives.
The grant program aims to support the progression of advanced HIV-1 vaccine candidates from pre-clinical studies to clinical testing phases. It focuses on facilitating technology transfer, preclinical immunogenicity, optimization studies, process and product development conforming to Current Good Manufacturing Practice (CGMP) standards, and regulatory filing. The grant encourages collaboration with Pharma/Biotech/Contract Manufacturing Organizations for CGMP manufacture, quality assurance/control, and regulatory submission preparation for clinical trials. Financially, it limits application budgets to $3 million direct costs per year for the first and second years of the award.