Integrated Preclinical / Clinical AIDS Vaccine Development Program (IPCAVD) (U19 Clinical Trial Not Allowed) | PAR 20 120

Opportunity Information: Apply for PAR 20 120

The Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (PAR 20-120) is a National Institutes of Health (NIH) funding opportunity that supports late-stage preclinical work needed to move a promising HIV/AIDS vaccine candidate into readiness for first-in-human or other early clinical testing. It is structured as a cooperative agreement (U19), which typically means NIH staff will have substantial involvement during the project period, and it is explicitly labeled “Clinical Trial Not Allowed.” In practical terms, the program is meant to fund the complicated, expensive, and highly regulated development steps that sit between an advanced research-stage vaccine concept and the point where a clinical trial application can be filed, without paying for the clinical trial itself.

The central goal of IPCAVD is translation: helping a multidisciplinary team take a vaccine candidate that is far enough along to be considered “advanced” and complete the remaining work needed for regulatory submission(s) that would allow clinical testing to begin. The FOA emphasizes the full package of development activities that commonly block progress when an academic or early biotech vaccine program tries to cross into the regulated clinical space. This includes final down-selection of the most viable candidate (for groups that may have multiple related constructs or platforms) and then building a development pathway that meets regulatory expectations for quality, manufacturing, and safety.

The funded scope is broad and intentionally end-to-end across preclinical-to-clinical transition tasks. Examples of supported activities include technology transfer (moving a process from a research lab into a manufacturing setting), process development and optimization (tightening and standardizing how the vaccine is produced), development and qualification of assays (so potency, identity, purity, and other key attributes can be measured reliably), and analytical testing necessary to define and control the product. The FOA also supports current Good Manufacturing Practice (cGMP) manufacturing, quality assurance oversight, safety testing, product release testing, and establishment of stability programs for both drug substance and drug product. It further includes IND-enabling studies (the preclinical studies generally required to support an Investigational New Drug application) and the preparation and submission of regulatory filings needed to open a clinical trial.

A key boundary in this opportunity is that it does not pay for running the clinical studies. Applicants are instead encouraged to line up a path to clinical execution through other mechanisms, such as collaborating with NIAID-supported clinical trial networks or building partnerships that can support trial implementation and funding once the regulatory package is ready. This design reflects a division of labor: IPCAVD funds the specialized development work to reach “trial-ready” status, while clinical networks or other sponsors fund and operate the trials.

Eligibility is intentionally broad and includes many organization types that might contribute to vaccine development, from universities and nonprofits to companies and government entities. Eligible applicants include state, county, city, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; public housing authorities/Indian housing authorities; and federally recognized tribal governments as well as tribal organizations that are not federally recognized governments. The FOA also highlights additional eligible categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) entities. This wide net fits the program’s multidisciplinary nature, where a single project may require academic discovery expertise, specialized assay labs, experienced regulatory teams, and cGMP manufacturing capabilities that may be distributed across multiple partners.

From an administrative standpoint, the opportunity is categorized as discretionary funding in the health area and is associated with CFDA number 93.855. The agency listed is NIH (with the program context pointing to NIAID given the reference to NIAID clinical trial networks). The FOA was created on 2020-03-03, and the original closing date shown is 2022-03-09. The award ceiling listed is $3,000,000. While the number of expected awards is not provided in the supplied source text, the ceiling indicates the program is designed to support substantial, resource-intensive development work that typically cannot be covered by smaller research grants.

Overall, IPCAVD is best understood as a “bridge-to-clinic” program for HIV/AIDS vaccines: it supports the manufacturing, testing, quality systems, and regulatory documentation needed to responsibly and credibly reach an IND (or similar regulatory milestone), while requiring applicants to plan for clinical testing through collaborations or other funding sources rather than using IPCAVD dollars to conduct the trials themselves.

• 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 2020-03-03.
• Applicants must submit their applications by 2022-03-09. (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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