Understanding the Clinical History of Bacterial Sexually Transmitted Infections (STI) to Accelerate Diagnostic and Vaccine Development (R01 Clinical Trial Not Allowed) | RFA AI 22 034

Opportunity Information: Apply for RFA AI 22 034

The grant opportunity titled "Understanding the Clinical History of Bacterial Sexually Transmitted Infections (STI) to Accelerate Diagnostic and Vaccine Development (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-AI-22-034) is a National Institutes of Health discretionary research grant focused on advancing the scientific understanding of three major bacterial sexually transmitted infections: syphilis, gonorrhea, and chlamydia. The central purpose is to fund studies that clarify the clinical history of these infections in humans, especially how the immune system responds from the point of infection through diagnosis and treatment. By building a more detailed and reliable picture of what happens during and after infection, the program aims to generate the kind of evidence that directly supports faster and more effective development of improved diagnostics and, critically, vaccines.

A key emphasis of this opportunity is the human immune response over time. Many persistent challenges in STI control trace back to gaps in understanding how immunity develops (or fails to develop) after natural infection, what immune signatures correlate with clearance or persistence, and how treatment alters immune trajectories. For vaccine and diagnostic developers, these details matter because they help define what a protective immune response should look like, what biomarkers best indicate recent versus past infection, and what biological signals could be used to detect infection earlier or more accurately. In practical terms, the funded research is meant to create a stronger knowledge base for identifying immune correlates of protection, mapping the kinetics of antibody and cellular responses, and understanding how infection stage and clinical presentation relate to measurable immune markers.

The funding mechanism is an R01 research project grant, and the notice specifies "Clinical Trial Not Allowed," meaning applicants are expected to propose non-interventional human subjects research rather than trials that prospectively assign participants to interventions. Projects can still involve clinical samples, observational cohorts, natural history studies, analysis of specimens collected during routine care, and other approaches that improve understanding of infection and immune responses in real-world clinical contexts, as long as they do not meet NIH's definition of a clinical trial. The scientific focus stays on clinical history and immunology in ways that are directly relevant to test and vaccine design rather than on testing a new intervention in participants.

Administratively, the opportunity is offered by the National Institutes of Health under CFDA number 93.855 and falls under the Health funding activity category. The original application closing date listed is 2022-09-12, and the posting creation date is 2022-05-12. The award ceiling is listed as 500,000, indicating an upper limit for the budget level anticipated per award within the terms of the announcement. While the expected number of awards is not specified in the provided data, the structure suggests a competitive NIH research program intended to support a set of investigator-initiated projects aligned to the stated aims.

Eligibility for this funding is broad and includes many types of U.S. domestic organizations and certain non-U.S. entities. 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; public housing authorities and Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (excluding institutions of higher education where applicable); 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities or foreign organizations, as well as Indian/Native American tribal governments other than federally recognized. This wide eligibility reflects an intent to encourage participation from diverse institutions, including those serving populations disproportionately affected by STIs or engaged in frontline sexual health services and surveillance.

Overall, the opportunity is designed to close critical knowledge gaps about how syphilis, gonorrhea, and chlamydia behave in humans and how the immune system responds across infection, diagnosis, and treatment. The expected payoff is practical: better-defined immune targets for vaccines and stronger biological foundations for next-generation diagnostics that can detect infection earlier, distinguish stages of disease more accurately, or better predict outcomes after treatment.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Understanding the Clinical History of Bacterial Sexually Transmitted Infections (STI) to Accelerate Diagnostic and Vaccine Development (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 2022-05-12.
• Applicants must submit their applications by 2022-09-12. (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 $500,000.00 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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