Partnerships for Development of Vaccines to Prevent Mycobacterium tuberculosis Infection and/or Disease (R01 Clinical Trial Not Allowed) | RFA AI 25 022

Opportunity Information: Apply for RFA AI 25 022

The National Institutes of Health (NIH) is offering a discretionary grant opportunity titled "Partnerships for Development of Vaccines to Prevent Mycobacterium tuberculosis Infection and/or Disease (R01 Clinical Trial Not Allowed)" under Funding Opportunity Number RFA-AI-25-022. It is an R01 research grant focused specifically on advancing tuberculosis (TB) vaccine candidates through preclinical development, with the bigger goal of strengthening and expanding the pipeline of vaccine products that are credible, test-ready contenders for later-stage clinical evaluation. As the title indicates, this solicitation does not allow clinical trials, so the supported work is expected to stay on the preclinical side rather than enrolling human participants.

The scientific purpose is centered on Mycobacterium tuberculosis (Mtb), the bacterium that causes TB, and the program is looking for applications that move beyond early discovery into the more rigorous stages of turning a promising vaccine concept into a lead candidate. In practical terms, this kind of NOFO is typically aimed at activities like refining vaccine constructs, improving formulation or delivery approaches, conducting key preclinical studies that justify advancement, generating data needed for downstream development decisions, and tackling known translational hurdles that often prevent candidates from reaching the clinic. The stated emphasis is on "preclinical development of lead candidate vaccines" intended to prevent Mtb infection and/or prevent TB disease, meaning applicants should be aiming at concrete vaccine candidates with a clear development path rather than purely exploratory immunology or hypothesis-only work.

The funding instrument is a grant, and the funding activity category is Health. The opportunity is associated with CFDA number 93.855, which corresponds to NIH infectious diseases-related programs administered through NIAID/NIH structures. While the notice does not provide a stated number of expected awards in the provided source data, it does list an award ceiling of $750,000, which sets an upper bound on how much may be awarded per project under this announcement (applicants generally still need to align requested budgets with the actual scope and allowable costs described in the full NOFO).

Eligibility is broad and includes many organization types that commonly participate in NIH funding, spanning public and private higher education institutions, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses) as well as small businesses, and multiple levels of government including state, county, city/township governments, special district governments, and independent school districts. It also includes Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments), plus public housing authorities/Indian housing authorities. In addition, this NOFO explicitly highlights other eligible applicants such as eligible federal agencies, faith-based or community-based organizations, Indian/Native American tribal governments that are not federally recognized, non-U.S. entities (foreign organizations), regional organizations, and U.S. territories or possessions. That combination signals NIH interest in fostering partnerships that may include international and community-linked groups, which can be particularly relevant for TB given its global burden and the need for development pathways that are informed by real-world use settings.

Key administrative details include an original closing date of 2025-11-07 and a creation date of 2025-08-26. The core takeaway is that NIH is seeking R01 applications that can credibly push one or more TB vaccine candidates forward through essential preclinical milestones, building a stronger set of viable candidates positioned for subsequent clinical testing under future, clinical-trial-appropriate funding mechanisms.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Partnerships for Development of Vaccines to Prevent Mycobacterium tuberculosis Infection and/or Disease (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 2025-08-26.
• Applicants must submit their applications by 2025-11-07. (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 $750,000.00 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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