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.Apply for RFA AI 17 039
- 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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FAQs: Understanding Immunopathogenesis of Tuberculosis in HIV-1 Infected and Exposed Children (R01 Clinical Trial Not Allowed)
What is the title of this funding opportunity?
The opportunity is titled "Understanding Immunopathogenesis of Tuberculosis in HIV-1 Infected and Exposed Children (R01 Clinical Trial Not Allowed)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-AI-17-039.
Which agency is offering this grant?
This is a National Institutes of Health (NIH) discretionary research grant opportunity.
What type of grant mechanism is used?
The activity mechanism is an R01 research project grant.
What is the overall scientific focus of this FOA?
The FOA supports mechanistic, immunology-focused studies at the intersection of pediatric tuberculosis (TB) and HIV-1. The central goal is to understand how Mycobacterium tuberculosis (Mtb) exposure, progression to infection, and development of active TB disease alter immune pathways and measurable immune markers in children who are infected with HIV-1 or exposed to HIV-1.
What does "immunopathogenesis" mean in the context of this opportunity?
In this FOA, immunopathogenesis refers to identifying immune changes that help explain differences in TB risk, TB presentation, and TB outcomes in pediatric groups affected by HIV-1. It also includes pinpointing immune markers that can be measured and tracked to better characterize these processes.
Which pediatric populations are specifically emphasized?
The FOA emphasizes two pediatric populations: (1) children living with HIV-1 infection and (2) children who are HIV-1 exposed (for example, perinatal exposure) even if they are not themselves infected.
What TB-related stages or conditions are of interest?
The FOA highlights immune alterations associated with multiple TB-related states, including Mtb exposure (contact without established infection), Mtb infection (often latent or asymptomatic infection), and TB disease (active clinical disease).
What kinds of scientific questions is the FOA trying to address?
Based on the description provided, the FOA is interested in questions such as which immune signatures reflect protective responses, which indicate susceptibility or immune dysregulation, and which correlate with progression to TB disease or severity in the context of HIV-1 infection or exposure.
What kinds of outcomes or deliverables does this FOA aim to produce?
The intended outputs include improved mechanistic insight into immune responses and identification (and potentially validation) of more informative immune markers. These outputs can support future efforts in risk stratification, earlier identification of children at highest risk for TB disease, and more targeted future approaches to prevention and care, while staying within a non-clinical-trial framework.
Are clinical trials allowed under this FOA?
No. The FOA explicitly states "Clinical Trial Not Allowed," meaning applications are expected to propose studies that do not meet the NIH definition of a clinical trial.
If clinical trials are not allowed, what kinds of study designs fit this FOA?
The description indicates that the FOA generally steers applicants toward non-interventional, mechanistic approaches such as observational human studies, analyses of specimens, immune phenotyping, laboratory-based mechanistic experiments, translational immunology, and other clinically relevant research designs that do not include prospectively assigned interventions or exposure arms.
Does the FOA support intervention testing (new treatments or prevention strategies)?
The summary describes the FOA as focused on deepening biological understanding and biomarker discovery or validation, rather than testing new interventions, treatment strategies, or prospectively assigned exposure arms.
What is meant by "HIV-1 exposed" children in this FOA?
The summary describes HIV-1 exposed children as those exposed to HIV-1 (for example, perinatally), even if they are not infected with HIV-1 themselves.
What organizations are eligible to apply?
Eligibility is described as broad. Eligible applicants include 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 nonprofit organizations with or without 501(c)(3) status (with the noted exclusion related to institutions of higher education in those nonprofit categories). The FOA also allows for-profit organizations (other than small businesses), small businesses, and other eligible entities depending on NIH policy and the FOA terms.
Are minority-serving institutions specifically mentioned as eligible?
Yes. The summary explicitly lists 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); and Indian/Native American Tribal Governments that are not federally recognized.
Can faith-based or community-based organizations apply?
Yes. The summary states that faith-based or community-based organizations are included among eligible applicant types.
Are U.S. territories or possessions eligible to apply?
Yes. The summary states that U.S. territories or possessions are eligible.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The summary indicates that non-domestic (non-U.S.) entities and regional organizations are eligible, and notes that this is especially relevant given that high-burden pediatric TB and HIV settings and cohorts are often outside the continental United States.
Are federal agencies eligible to apply?
Yes. The summary includes eligible federal agencies among the eligible applicant types.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.855.
What is the closing date for applications listed in the summary?
The original closing date listed is March 14, 2018.
What is the FOA creation date?
The FOA creation date listed is December 4, 2017.
Is the award ceiling provided in the summary?
No. The provided summary data does not specify an award ceiling.
Does the summary state the expected number of awards?
No. The provided summary data does not specify the expected number of awards.
Where should applicants look for budget limits, project period limits, or institute-specific expectations?
The summary indicates that applicants would typically need to consult the full FOA text and NIH budget guidance for details such as allowable budgets, project period limits, and any institute-specific funding expectations.
What area is this opportunity categorized under?
The opportunity is categorized under health research.
Why does the FOA emphasize immune markers and immune pathways?
The summary describes an emphasis on identifying measurable immune markers and immune pathway changes that could explain differences in TB risk, presentation, progression, and outcomes among children with HIV-1 infection or HIV-1 exposure.
Does the FOA encourage comparisons across different TB states (exposure, infection, disease)?
Yes. The FOA explicitly highlights interest in capturing and comparing immune alterations linked to Mtb exposure, Mtb infection, and active TB disease in the pediatric populations described.
What is the practical value of the research supported by this FOA?
As described, the practical value is to build a clearer mechanistic understanding and identify immune markers that can support better characterization of TB immunopathogenesis in HIV-1 affected children. This groundwork can support future improvements in risk stratification and earlier identification of children at higher risk for TB disease.
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