Host Immunity and Novel Immunization Strategies for Clostridioides difficile Infection (CDI) (U19 Clinical Trial Not Allowed) | RFA AI 22 001

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The Host Immunity and Novel Immunization Strategies for Clostridioides difficile Infection (CDI) funding opportunity (RFA-AI-22-001) is a National Institutes of Health (NIH) cooperative agreement that aims to build Cooperative Research Centers (CRCs) focused on accelerating vaccine development for Clostridioides difficile. The central idea is that progress in CDI vaccines depends on a much clearer, more complete understanding of what protective immunity against CDI looks like in real people and in well-designed experimental models, and then using that knowledge to identify better vaccine targets and delivery approaches. This opportunity is explicitly labeled "U19 Clinical Trial Not Allowed," meaning the supported work is intended to be preclinical and translational research rather than human interventional clinical trials, even though the research may draw heavily from human clinical specimens and observations.

The program is designed around multidisciplinary, center-style collaboration rather than isolated projects. Applicants are expected to bring together complementary expertise across immunology, microbiology, vaccinology, adjuvant science, antigen discovery, clinical infectious diseases, and model system development. The cooperative agreement structure also signals that NIH anticipates substantial scientific involvement during the award period, with ongoing coordination between the funded centers and the agency to keep the research aligned with the program goals and to promote harmonization and sharing where appropriate. In practical terms, this type of mechanism usually supports coordinated research components that function as an integrated center with shared direction, common goals, and a plan to generate outputs that are more impactful than what single laboratories could accomplish independently.

Scientifically, the emphasis is on advancing knowledge of host immunity to CDI and translating that knowledge into next-generation vaccine concepts. Key themes include leveraging clinical samples to understand immune responses associated with susceptibility, protection, or recovery; identifying novel protective antigens beyond the standard set of known targets; and exploring novel vaccine platforms and adjuvant strategies that might elicit stronger, broader, or more durable protective responses. Because CDI is tightly linked to gut ecology and mucosal immunity, the initiative is implicitly oriented toward understanding immune mechanisms in the context of the intestinal environment, including how systemic and mucosal immune responses interact, what kinds of antibodies or cellular responses correlate with protection, and how immune responses might prevent colonization, toxin-mediated disease, recurrence, or transmission. The FOA frames the end use of these discoveries as guidance for vaccine design that can be tested in appropriately devised model systems, highlighting the expectation that applicants will use or develop models capable of evaluating immune mechanisms and vaccine performance in a way that informs eventual clinical translation.

The funding instrument is a discretionary cooperative agreement under the health activity category, associated with CFDA number 93.855. The listed award ceiling is $1,000,000, and the original closing date shown in the source data is 2022-05-20, with a creation date of 2022-01-07. While the source snippet does not state the exact number of expected awards, it indicates that NIH anticipated making multiple awards under this announcement to support the CRC concept, which typically involves funding several coordinated centers rather than a single site.

Eligibility is broad and includes many organization types across academia, government, nonprofit, and industry. Eligible applicants include state, county, and local 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/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights 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), Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions. Taken together, that eligibility language signals an intention to attract a diverse range of research organizations and to support capacity across different institutional settings, including those serving underrepresented or geographically distinct populations.

Overall, the opportunity is best understood as a targeted NIH effort to move CDI vaccine development forward by investing in coordinated centers that can connect clinical immunology insights to antigen discovery and modern vaccine design. The expected outputs are the kinds of data and prototype approaches that can de-risk and inform subsequent vaccine development stages: clearer immune correlates and mechanisms, validated or prioritized antigen candidates, evidence for promising adjuvant or platform choices, and rigorous evaluation in model systems that reflect key features of CDI pathogenesis and immunity.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Host Immunity and Novel Immunization Strategies for Clostridioides difficile Infection (CDI) (U19 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 2022-01-07.
• Applicants must submit their applications by 2022-05-20. (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 $1,000,000.00 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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