The National Institutes of Health (NIH), through the National Institute of Allergy and Infectious Diseases (NIAID), has issued a funding opportunity titled “Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD)” under FOA number PAR-23-033. This opportunity, supporting U19 cooperative agreements, is intended to advance HIV-1 vaccine candidates from preclinical stages through product development, manufacturing, and regulatory processes up to clinical testing. The program will support multidisciplinary efforts involving research, technology transfer, process development, Current Good Manufacturing Practice (CGMP) manufacturing, quality assurance, and other regulatory activities. Each award recipient must establish partnerships, which may include industry collaborations, to manage manufacturing and prepare for Investigational New Drug (IND) submissions.

This FOA aims to facilitate the development of vaccine candidates that elicit broadly neutralizing antibodies (bnAbs) to prevent HIV infection, focusing on platforms such as stabilized envelope trimers, nanoparticles, mRNA, and self-replicating RNA that optimize manufacturing processes or offer dose-sparing benefits. Supported activities include preclinical immunogenicity and optimization studies, formulation development, quality control testing, fill-finish processes, and the establishment of storage and stability programs per FDA guidelines. To qualify, applicants must include detailed development plans, clinical partnerships, and milestone-driven criteria to achieve readiness for clinical trials within the five-year project period.

Eligible applicants include higher education institutions, nonprofit organizations, for-profit entities, and government agencies. The application budget is limited to $3 million in direct costs per year for the first two years, with flexibility for increased costs for CGMP manufacturing in later years. Applicants are required to submit a milestone plan, with specific Go/No-Go criteria assessed at the end of Year 2 to ensure readiness for CGMP manufacturing by Year 3. By Year 5, awardees are expected to initiate clinical trials supported by funding mechanisms outside the IPCAVD program.

The application package must include a minimum of two projects, one of which should focus on product manufacturing, and may include optional scientific cores. An administrative core will manage program coordination, and each awardee must establish an External Advisory Committee (EAC) to monitor project progress. Applications will be evaluated based on significance, investigator qualifications, innovation, approach, environment, and milestone planning. The clinical development plan must outline collaboration with a clinical partner to ensure trial readiness by Year 5.

Key dates for submission are March 15, 2024, and March 14, 2025, with scientific merit reviews in July each year and advisory council reviews in October. Applications must be submitted electronically, and applicants are encouraged to submit early to allow for potential error corrections. All applications will undergo an NIH peer review, assessing scientific merit, feasibility, and alignment with program priorities. Successful applicants will receive a Notice of Award (NoA) with NIH oversight throughout the project period, including data management, progress reporting, and adherence to NIH and FDA regulatory guidelines.