Innovation for Tuberculosis Vaccine Discovery (ITVD) (R61/R33 Clinical Trial Not Allowed) | RFA AI 21 007

Opportunity Information: Apply for RFA AI 21 007

Innovation for Tuberculosis Vaccine Discovery (ITVD) (R61/R33 Clinical Trial Not Allowed), Funding Opportunity Number RFA-AI-21-007, is a National Institutes of Health (NIH) discretionary grant program focused on accelerating the early discovery and preclinical development of new tuberculosis (TB) vaccine candidates. The core purpose is to fund the design of novel TB vaccine concepts that use innovative scientific approaches, and then push the most promising candidates forward into testing in relevant preclinical animal models. The emphasis is on moving beyond conventional ideas by supporting creative, potentially high-impact strategies that could expand the TB vaccine pipeline.

A defining feature of this opportunity is its milestone-driven, two-phase structure using the R61/R33 mechanism. The first phase (R61) is intended for high-risk, exploratory work where investigators generate proof-of-concept data, refine vaccine designs, and establish feasibility. This phase is deliberately geared toward innovation, where outcomes are uncertain but the potential payoff is high. The second phase (R33) supports more advanced activities, particularly preclinical animal model testing, but it is not automatic. Progression from R61 to R33 depends on whether the project meets predefined scientific milestones and go/no-go criteria. In practice, this structure is meant to keep projects focused on measurable progress, encourage disciplined development planning, and ensure that additional funding is concentrated on candidates that demonstrate strong potential based on early results.

The scope of supported work centers on vaccine discovery and preclinical evaluation rather than human studies. The announcement explicitly states that clinical trials are not allowed, which signals that applicants should not propose any clinical testing in humans under this mechanism. Instead, the program is aimed at the earlier parts of the translational pathway: designing and engineering vaccine candidates, generating supporting immunogenicity or mechanistic evidence, and evaluating candidates in animal models appropriate for TB preclinical research.

From an eligibility standpoint, the opportunity is broadly open to a wide range of domestic and international organizations. Eligible applicants include various levels of government (state, county, city/township, and special district governments), federally recognized Native American tribal governments, and Native American tribal organizations other than federally recognized tribal governments. It also includes public housing authorities/Indian housing authorities, independent school districts, and both public/state-controlled and private institutions of higher education. Nonprofit organizations are eligible whether or not they hold 501(c)(3) status, and for-profit organizations (including small businesses) can also apply. In addition, the opportunity highlights expanded categories of eligible applicants 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, and non-U.S. entities (foreign organizations) as well as regional organizations. This broad eligibility is consistent with the global importance of TB and the need to draw on diverse scientific and institutional capabilities.

Administratively, the opportunity sits within NIH under the health research activity category and is associated with CFDA number 93.855. The listing indicates an original closing date of 2021-06-30 and a creation date of 2021-02-19. While the summary data provided does not specify an award ceiling or the expected number of awards, the overall design of the program makes clear that funding decisions are tied closely to the feasibility of the proposed milestones and the likelihood that the work can yield a viable vaccine candidate ready for rigorous preclinical assessment.

Overall, ITVD (R61/R33) is designed for teams proposing bold TB vaccine ideas with a clear, testable development path. It supports projects that can define concrete milestones early, generate decisive preclinical evidence, and demonstrate that an innovative candidate warrants continued investment, all while keeping the work firmly in the non-clinical, preclinical stage.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovation for Tuberculosis Vaccine Discovery (ITVD) (R61/R33 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 2021-02-19.
• Applicants must submit their applications by 2021-06-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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