Innovation for HIV Vaccine Discovery (R01 Clinical Trial Not Allowed) | PAR 23 169

Opportunity Information: Apply for PAR 23 169

Innovation for HIV Vaccine Discovery (R01 Clinical Trial Not Allowed), PAR 23-169, is a National Institutes of Health (NIH) discretionary grant opportunity focused on pushing forward early-stage HIV vaccine ideas that are deliberately high-risk but potentially high-impact. The program is aimed at discovery research rather than later-stage development, and it is specifically about vaccine approaches intended to prevent acquiring HIV or to prevent/limit ongoing infection. A key feature is that clinical trials are not allowed under this announcement, which signals that the work should stay in preclinical, mechanistic, or other early discovery phases rather than enrolling human participants in interventional clinical studies.

What sets this opportunity apart from a typical R01 is its Go/No-Go funding structure. Applicants are expected to propose bold concepts along with clear, testable milestones, and continued support is tied to performance against negotiated Go/No-Go criteria by the end of Year 2. In practical terms, NIH is using a milestone-based decision point: if the project demonstrates enough progress by that second-year checkpoint, it can continue for the remainder of the award period; if it does not meet the agreed criteria, funding may be discontinued. This structure is meant to encourage innovative approaches that might not fare well in more conventional grant mechanisms, while still ensuring accountability and efficient use of funds.

The award is offered as a grant under the NIH Funding Instrument Type, within the health activity category (CFDA number 93.855). The listing notes an award ceiling of $350,000, which generally indicates an upper bound on budget in the source summary (applicants should still confirm specific budget rules and allowable costs in the full FOA on NIH/Grants.gov because NIH budgets can be expressed in direct costs, total costs, per-year limits, and/or modular formats depending on institute policies and the FOA’s detailed instructions). The opportunity was created on 2023-04-20, and the original closing date shown is 2025-08-01.

Eligibility is broad and includes many common applicant types across academia, government, nonprofit, and industry. 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; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly calls out additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; U.S. territories or possessions; regional organizations; Indian/Native American tribal governments other than federally recognized; and non-U.S. (foreign) organizations, emphasizing that a wide range of institutions and communities can participate.

Overall, this FOA is best understood as NIH’s attempt to create space for unconventional, early discovery HIV vaccine concepts that could meaningfully change the field if they work, while using a structured milestone checkpoint to decide whether to keep investing beyond the first two years. Applicants considering it should be prepared to justify why their idea is innovative and potentially transformative, and to lay out concrete Year 1-2 deliverables that can serve as credible Go/No-Go decision criteria under an R01 framework that does not include clinical trials.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovation for HIV Vaccine Discovery (R01 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 2023-04-20.
• Applicants must submit their applications by 2025-08-01. (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 $350,000.00 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.

Apply for PAR 23 169

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