Integrated Preclinical / Clinical AIDS Vaccine Development Program (IPCAVD) (U19 Clinical Trial Not Allowed) | PAR 23 033

Opportunity Information: Apply for PAR 23 033

The Integrated Preclinical / Clinical AIDS Vaccine Development Program (IPCAVD) (U19 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) cooperative agreement opportunity (Funding Opportunity Number PAR-23-033; CFDA 93.855) designed to move promising, advanced HIV-1 vaccine candidates out of the lab and into a state of readiness for first-in-human clinical testing. The core aim is translation: taking vaccine concepts that already have strong preclinical justification and supporting the practical, regulated development work needed to reach the point where a clinical trial could begin. Even though the endpoint is clinical-test readiness, the award itself does not support conducting clinical trials under this FOA, which is reflected in the "Clinical Trial Not Allowed" designation.

This program focuses on the full set of late-stage preclinical and CMC (Chemistry, Manufacturing, and Controls) activities that typically block or delay promising vaccine candidates from entering the clinic. Supported activities include technology transfer (for example, moving a process from an academic lab into an industrial or contract manufacturing setting), preclinical immunogenicity studies and optimization to refine the candidate and its performance, and structured process development to make manufacturing reproducible and scalable. The FOA also emphasizes analytical assay development and the work required to make those assays credible for regulated decision-making, including qualification, validation, and testing. Applicants can propose small-scale pilot or engineering runs to de-risk manufacturing prior to full CGMP production.

A major component of IPCAVD is support for Current Good Manufacturing Practice (CGMP) manufacturing and the real-world operational steps needed to produce clinical-grade material. This includes partnering with pharmaceutical or biotechnology companies and/or Contract Manufacturing Organizations (CMOs), establishing quality assurance and quality control oversight, performing fill-finish operations, and completing product release and storage activities. The FOA explicitly calls out the creation of reference standards, along with drug substance and drug product stability testing programs, all of which are essential for demonstrating consistency, shelf-life, and readiness for clinical supply management.

On the regulatory side, IPCAVD supports IND-enabling studies and preparation for regulatory submissions, including development of the documentation and data packages used to support an Investigational New Drug (IND) application. In practical terms, the opportunity is aimed at funding the evidence and records that regulators expect to see before a vaccine can be administered to humans, such as validated analytics, stability data, manufacturing records under CGMP, and the nonclinical work needed to justify clinical exposure. The program is structured as a cooperative agreement (U19), which generally means substantial NIH scientific or programmatic involvement during the project period, with coordination and milestone-driven progress being common expectations.

Eligibility is broad and includes many types of domestic applicants as well as certain non-U.S. entities. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), non-domestic (non-U.S.) entities (foreign organizations), regional organizations, eligible federal agencies, and U.S. territories or possessions. This breadth signals that NIH is open to proposals from academic groups, nonprofits, industry, and international partners, as long as the team can credibly execute advanced development and regulated manufacturing preparation.

Key administrative details include an original closing date of 2025-03-14 and an award ceiling listed at $3,000,000. The opportunity category is discretionary, the activity category is health, and the funding instrument is a cooperative agreement. Overall, IPCAVD is best understood as a bridge program for HIV-1 vaccine candidates that are beyond basic discovery: it funds the manufacturing, testing, quality systems, and regulatory groundwork required to reach a clinic-ready package, while stopping short of paying for the clinical trial itself.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Integrated Preclinical / Clinical AIDS Vaccine Development Program (IPCAVD) (U19 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2022-10-31.
• Applicants must submit their applications by 2025-03-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $3,000,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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