Partnerships for Development of Vaccines to Prevent Mycobacterium tuberculosis Infection and/or Tuberculosis Disease (R01) | RFA AI 16 079

Opportunity Information: Apply for RFA AI 16 079

The government grant opportunity titled "Partnerships for Development of Vaccines to Prevent Mycobacterium tuberculosis Infection and/or Tuberculosis Disease (R01)" (Funding Opportunity Number RFA-AI-16-079) is a National Institutes of Health (NIH) discretionary grant program in the health category designed to move promising tuberculosis vaccine concepts toward practical readiness. The central aim is to support milestone-driven research projects that can establish proof-of-concept and/or advance preclinical development for lead vaccine candidates intended to prevent infection with Mycobacterium tuberculosis (Mtb) and/or prevent tuberculosis (TB) disease. In plain terms, this FOA is focused on helping research teams generate the kinds of rigorous, decision-enabling data needed to determine whether a vaccine candidate is strong enough to justify further development, including the kind of preclinical package that can support later-stage translational work.

A key feature of this announcement is its emphasis on partnerships and clear development milestones. Rather than funding open-ended basic research, the structure is oriented toward defined go/no-go decision points, with measurable objectives that keep projects aligned with product-focused progress. Applicants are expected to propose a coherent plan that moves a lead candidate (or a small set of candidates) through proof-of-concept and preclinical steps that meaningfully reduce risk. This can include activities such as refining vaccine constructs, demonstrating protective effects in relevant experimental systems, optimizing dosing or delivery, establishing immune response readouts, and generating data that supports selection of a development candidate. The overall intent is to accelerate advancement of vaccine candidates that target either Mtb infection, TB disease, or both, recognizing that prevention can be approached at different stages of the pathogen and disease process.

The award is offered as an NIH R01 research project grant, indicating support for a defined research program led by a principal investigator, typically with one or more collaborating partners. While the summary does not list the exact number of expected awards, it does specify an award ceiling of $1,050,000, signaling that the program anticipates substantial, development-oriented budgets consistent with preclinical vaccine work. The CFDA numbers associated with this opportunity are 93.855 and 93.856, which correspond to NIH infectious disease-related funding areas.

Eligibility is broad and intentionally inclusive, spanning many types of U.S. and non-U.S. organizations. Eligible applicants include state, county, and city or township governments; 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities and 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 FOA also explicitly calls out additional eligible applicant categories 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, non-domestic (non-U.S.) entities (foreign organizations), U.S. territories or possessions, and Indian/Native American tribal governments that are not federally recognized. This breadth reflects an intent to encourage cross-sector and cross-geography collaborations, which is often important for TB vaccine development given the global burden of disease and the need for expertise and infrastructure that may be distributed across different regions and institution types.

From an administrative timeline perspective, the opportunity was created on 2016-10-05 and had an original closing date of 2017-03-02. The sponsoring agency is the National Institutes of Health. Overall, the FOA can be understood as a targeted, product-development-oriented NIH funding mechanism aimed at pushing TB vaccine candidates beyond early discovery into credible proof-of-concept and preclinical readiness, using milestone-based management and encouraging a wide range of eligible organizations to participate.

• 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 Tuberculosis Disease (R01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855, 93.856.
• This funding opportunity was created on 2016-10-05.
• Applicants must submit their applications by 2017-03-02. (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 $1,050,000.00 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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