Understanding Immunopathogenesis of Tuberculosis in HIV-1 Infected and Exposed Children (R01 Clinical Trial Not Allowed) | RFA AI 17 039

Opportunity Information: Apply for RFA AI 17 039

The grant opportunity titled "Understanding Immunopathogenesis of Tuberculosis in HIV-1 Infected and Exposed Children (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-AI-17-039) is a National Institutes of Health (NIH) discretionary research grant intended to support mechanistic, immunology-focused studies at the intersection of pediatric tuberculosis (TB) and HIV-1. In practical terms, the FOA is centered on understanding how exposure to Mycobacterium tuberculosis (Mtb), progression to infection, and development of active TB disease alter immune pathways and measurable immune markers in children who are either infected with HIV-1 or have been exposed to HIV-1. The emphasis is on immunopathogenesis: identifying the immune changes that help explain why TB risk, TB presentation, and TB outcomes differ in these pediatric groups, and pinpointing markers that can be tracked to better characterize these processes.

A key feature of the announcement is its focus on pediatric populations affected by HIV-1 in two ways: children living with HIV-1 infection and children who are HIV-1 exposed (for example, exposed perinatally) even if they are not themselves infected. The scientific goal is to capture and compare immune alterations associated with different stages of TB-related biology, including Mtb exposure (contact without established infection), Mtb infection (often latent or asymptomatic infection), and TB disease (active clinical disease). By encouraging applications that identify immune mechanisms and markers linked to these states, the FOA signals interest in work that can disentangle which immune signatures reflect protective responses, which reflect susceptibility or dysregulation, and which correlate with disease progression or severity in the context of HIV-1.

The activity mechanism is an R01 research project grant, and the FOA explicitly indicates "Clinical Trial Not Allowed," meaning applicants are expected to propose studies that do not meet the NIH definition of a clinical trial. This generally steers proposals toward observational human studies, analyses of specimens and immune phenotyping, laboratory-based mechanistic experiments, translational immunology, and other non-interventional designs that can still be clinically relevant. In other words, the FOA is positioned for projects that deepen biological understanding and biomarker discovery or validation, rather than testing new interventions, treatment strategies, or prospectively assigned exposure arms.

From an eligibility standpoint, the FOA is broad and inclusive. Eligible applicants include many types of U.S.-based organizations and governmental entities, such as state, county, 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/Indian housing authorities; and a range of nonprofit entities both with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories). It also allows for for-profit organizations (other than small businesses) and small businesses, as well as "other" eligible entities depending on NIH policy and the FOA terms.

The announcement also calls out additional eligible applicant types that often reflect a desire to broaden participation and ensure that research capacity and community relevance are represented. These include Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); and Indian/Native American Tribal Governments that are not federally recognized. It also allows eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, and importantly, non-domestic (non-U.S.) entities and regional organizations. The inclusion of foreign organizations is especially relevant for pediatric TB and HIV research, since high-burden settings and established pediatric cohorts are often located outside the continental United States, and collaborations with regional institutions can be essential for access to well-characterized populations and specimens.

Administratively, the opportunity is categorized under health research and is associated with CFDA number 93.855. The original closing date listed for applications was March 14, 2018, and the FOA creation date is December 4, 2017. The provided summary data does not specify an award ceiling or the expected number of awards, which typically means prospective applicants would need to consult the full FOA text and NIH budget guidance for details on allowable budgets, project period limits, and any institute-specific funding expectations.

Overall, this FOA is aimed at advancing the field's understanding of how HIV-1 infection or HIV-1 exposure shapes pediatric immune responses to Mtb across the spectrum from exposure to disease. The intended outputs are improved mechanistic insight and more informative immune markers, which can lay groundwork for better risk stratification, earlier identification of children at highest risk for TB disease, and more targeted future approaches to prevention and care, while remaining firmly within a non-clinical-trial research framework.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Understanding Immunopathogenesis of Tuberculosis in HIV-1 Infected and Exposed Children (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 2017-12-04.
• Applicants must submit their applications by 2018-03-14. (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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