Analyzing Early Events in TB and TB/HIV Infection for Interventional Targets (R01 Clinical Trial Not Allowed) | RFA AI 23 029

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The grant opportunity "Analyzing Early Events in TB and TB/HIV Infection for Interventional Targets (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-AI-23-029) is a discretionary research grant from the National Institutes of Health (NIH) in the health area (CFDA 93.855). Its central goal is to fund mechanistic, hypothesis-driven studies that focus on the earliest stages of Mycobacterium tuberculosis (Mtb) infection, looking both at TB alone and TB in the context of HIV co-infection. The emphasis on "early events" signals an interest in what happens at the very beginning of infection and the initial host-pathogen interactions that can shape whether someone clears infection, contains it, progresses to latent infection, or advances toward active disease. By understanding these early biological steps in detail, the FOA aims to surface specific, actionable intervention points that could be used to design or improve TB vaccines and to develop host-directed therapies, meaning approaches that modify the host response (rather than directly targeting the bacterium) to prevent infection from taking hold or to limit early disease progression.

A key feature of this announcement is the explicit focus on identifying interventional targets. In practical terms, applicants are expected to do more than describe associations; they should generate mechanistic insights that help pinpoint vulnerabilities in the pathogen, critical immune pathways, cellular interactions, or microenvironmental factors that could be manipulated to block establishment of infection or alter early disease trajectories. Because the FOA is framed around TB and TB/HIV, it highlights the importance of understanding how HIV-related immune changes reshape early TB infection biology, potentially altering early immune containment, granuloma formation dynamics, inflammatory signaling, or tissue-level events that influence bacterial survival and dissemination. The overall intent is to support research that can connect early-stage mechanisms to tangible prevention or therapeutic strategies, especially those that could inform next-generation vaccines or adjunctive host-directed interventions.

The award mechanism is an R01, which typically supports substantial, multi-year research projects with clearly defined aims, rigorous experimental approaches, and strong justification for significance and innovation. The title includes "Clinical Trial Not Allowed," which means the funded work should not be a clinical trial. In other words, the FOA is aimed at foundational and translational mechanistic research rather than testing interventions in human participants in a clinical trial framework. Projects may still involve human-derived samples, observational work, or laboratory-based analyses depending on NIH policy definitions, but the proposed research should not be structured as a clinical trial intended to prospectively assign human participants to an intervention to evaluate health outcomes.

Eligibility is broad and includes many common applicant types such as state, county, and local governments; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out additional eligible applicants, reflecting an intent to include a wide range of institutions and communities: 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, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations), as well as Indian/Native American tribal governments that are not federally recognized. This broad eligibility suggests NIH is open to diverse partnerships and global or community-relevant settings where early TB and TB/HIV biology can be studied, while still keeping the scientific focus on mechanistic discovery and target identification.

Key administrative details provided include an original closing date of October 11, 2023, and a creation date of May 15, 2023. The source information does not specify an award ceiling, expected number of awards, or other funding totals, indicating those fields were not provided in the excerpt. Overall, this FOA is best understood as a targeted NIH solicitation designed to accelerate early-stage TB and TB/HIV mechanistic research specifically in service of identifying intervention points that can feed directly into vaccine concepts and host-directed therapeutic strategies, without funding clinical trials under this particular announcement.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Analyzing Early Events in TB and TB/HIV Infection for Interventional Targets (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 2023-05-15.
• Applicants must submit their applications by 2023-10-11. (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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