Biomarker Signatures of TB Infection in Young Children With and Without HIV (R01 Clinical Trial Not Allowed) | RFA AI 22 015

Opportunity Information: Apply for RFA AI 22 015

The Biomarker Signatures of TB Infection in Young Children With and Without HIV funding opportunity (RFA-AI-22-015) is a discretionary NIH research grant announcement that supports R01 projects focused on identifying and validating new biomarker signatures for tuberculosis infection in young children, specifically including cohorts with and without HIV. The core aim is to improve how TB infection is detected and how the risk of progressing from infection to active TB disease is predicted in early childhood, a period when TB can be difficult to diagnose and when disease progression can be rapid and severe, particularly for children living with HIV or otherwise immunocompromised. The FOA emphasizes discovery and validation, meaning applicants are expected to move beyond purely exploratory work by developing biomarkers that can be tested, confirmed, and shown to be meaningfully associated with TB infection status and/or future progression to TB disease in these pediatric populations.

This opportunity uses the NIH R01 mechanism and is labeled "Clinical Trial Not Allowed," which generally signals that the proposed work should not be a prospective intervention study where participants are assigned to receive specific interventions to evaluate health outcomes. In practice, projects typically fit into clinical and translational research that may involve human specimens and observational cohorts, such as leveraging existing pediatric cohorts, collecting and analyzing biospecimens, or using well-characterized sample sets to discover immune, transcriptomic, proteomic, metabolomic, or other molecular signatures linked to TB infection and progression risk. A strong application would usually articulate a clear plan for how candidate biomarkers will be identified, how they will be technically and clinically validated, and what evidence will demonstrate that the biomarkers add value compared to current tools.

The administering agency is the National Institutes of Health, and the funding activity falls under Health, Income Security and Social Services. The CFDA numbers associated with the opportunity are 93.855 and 93.865. The announcement was created on February 9, 2022, with an original closing date of June 8, 2022. The listed award ceiling is $700,000, indicating the maximum amount expected per award under the announcement parameters, and while the notice references expected awards, the specific number is not provided in the source details included here.

Eligibility is broad and includes many common federal applicant categories: state, county, and city/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 and without 501(c)(3) status (excluding institutions of higher education as specified); for-profit organizations other than small businesses; small businesses; and other entities. In addition, the FOA explicitly highlights eligibility for a range of institution types and organizations, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based and community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This wide eligibility reflects the global and community-embedded nature of pediatric TB and pediatric HIV research, where critical expertise, cohorts, and biobanks may exist both within and outside the United States.

Overall, the opportunity targets a high-impact gap in pediatric infectious disease research: better biological readouts that can distinguish TB infection states and forecast which young children are most likely to progress to active disease, including within the added complexity of HIV co-infection. Projects funded under this FOA are intended to strengthen the evidence base for next-generation diagnostic or prognostic approaches and to support biomarker development efforts that could eventually inform earlier detection, smarter risk stratification, and improved prevention strategies for young children at risk of TB disease.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Biomarker Signatures of TB Infection in Young Children With and Without HIV (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, 93.865.
• This funding opportunity was created on 2022-02-09.
• Applicants must submit their applications by 2022-06-08. (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 $700,000.00 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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