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.Apply for RFA AI 25 022
- 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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FAQs: Partnerships for Development of Vaccines to Prevent Mycobacterium tuberculosis Infection and/or Disease (R01 Clinical Trial Not Allowed)
1. What is this funding opportunity?
This is a discretionary research grant opportunity from the National Institutes of Health (NIH) titled "Partnerships for Development of Vaccines to Prevent Mycobacterium tuberculosis Infection and/or Disease (R01 Clinical Trial Not Allowed)." The Funding Opportunity Number is RFA-AI-25-022.
2. What type of grant mechanism is being used?
The opportunity uses the NIH R01 research project grant mechanism.
3. Are clinical trials allowed under this opportunity?
No. Clinical trials are not allowed under this solicitation. The supported work is expected to remain preclinical and should not involve enrolling human participants.
4. What disease area and pathogen does this program focus on?
The program is focused on tuberculosis (TB) and specifically on Mycobacterium tuberculosis (Mtb), the bacterium that causes TB.
5. What is the main scientific goal of the program?
The main goal is to strengthen and expand the pipeline of tuberculosis vaccine products by advancing credible, test-ready vaccine contenders through preclinical development so they are positioned for later-stage clinical evaluation in the future.
6. What kinds of projects is NIH looking for?
Applications are expected to move beyond early discovery and focus on the preclinical development of lead candidate vaccines. This includes work that turns a promising vaccine concept into a more development-ready candidate with a clear path toward future clinical testing (under a different, clinical-trial-appropriate mechanism).
7. Does the opportunity support early-stage discovery or purely exploratory work?
The stated emphasis is on "preclinical development of lead candidate vaccines" rather than purely exploratory immunology or hypothesis-only research. Applicants are expected to propose concrete vaccine candidates and a credible development path.
8. What outcomes are vaccine candidates expected to address?
Vaccine candidates should be intended to prevent Mycobacterium tuberculosis infection and/or prevent tuberculosis disease.
9. What types of activities are typically aligned with this NOFO's preclinical focus?
Based on the description provided, this NOFO is typically aimed at activities such as refining vaccine constructs, improving formulation or delivery approaches, conducting key preclinical studies that justify advancement, generating data needed for downstream development decisions, and addressing translational hurdles that commonly prevent candidates from reaching clinical testing.
10. What is the funding instrument and activity category?
The funding instrument is a grant, and the funding activity category is Health.
11. What is the associated CFDA number?
The opportunity is associated with CFDA number 93.855, which corresponds to NIH infectious diseases-related programs administered through NIAID/NIH structures.
12. What is the maximum award amount (award ceiling)?
The award ceiling listed for this announcement is $750,000. This is the upper bound stated in the provided information.
13. Does the provided information state how many awards NIH expects to make?
No. The provided source data does not include a stated number of expected awards.
14. Who is eligible to apply?
Eligibility is broad and includes many organization types, including:
- Public and private institutions of higher education
- Nonprofit organizations (501(c)(3) and non-501(c)(3))
- For-profit organizations (other than small businesses) and small businesses
- State, county, city/township, special district governments, and independent school districts
- Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments)
- Public housing authorities/Indian housing authorities
- 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
- U.S. territories or possessions
15. Are foreign (non-U.S.) organizations eligible to apply?
Yes. The NOFO explicitly includes non-U.S. entities (foreign organizations) among eligible applicants.
16. Are small businesses eligible?
Yes. Small businesses are included among eligible applicants.
17. Are community-based and faith-based organizations eligible?
Yes. The NOFO explicitly highlights faith-based or community-based organizations as eligible applicants.
18. Are tribal entities eligible?
Yes. Eligibility includes federally recognized Native American tribal governments, tribal organizations (other than federally recognized tribal governments), and also explicitly highlights Indian/Native American tribal governments that are not federally recognized.
19. What is the key partnership idea implied by the opportunity title?
While specific partnership requirements are not detailed in the provided information, the title signals an emphasis on partnerships that support the development of tuberculosis vaccine candidates through preclinical milestones.
20. What is the application closing date?
The original closing date listed is 2025-11-07.
21. When was this opportunity created?
The creation date listed is 2025-08-26.
22. What is the overall "big picture" purpose of the funding?
The core takeaway is that NIH is seeking R01 applications that can credibly push one or more TB vaccine candidates through essential preclinical milestones, thereby increasing the number of viable candidates positioned for subsequent clinical testing under future funding mechanisms that allow clinical trials.
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