Opportunity Information: Apply for PAR 16 254
Apply for PAR 16 254
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Mechanisms of Mycobacterial-Induced Immunity in HIV-Infected and Uninfected Individuals to Inform Tuberculosis Vaccine Design (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855, 93.856,.
- This funding opportunity was created on May 11, 2016 and posted on May 11, 2016.
- Applicants must submit their applications by Sep 06, 2018. (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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
Mechanisms of Mycobacterial-Induced Immunity in HIV-Infected and Uninfected Individuals to Inform Tuberculosis Vaccine Design (R01) is an NIH funding opportunity (PAR-16-254) that supports research aimed at improving tuberculosis (TB) vaccine development by clarifying how the human immune system responds to mycobacteria. The central focus is on identifying and dissecting the innate and adaptive immune responses triggered by natural mycobacterial infection, the Bacillus Calmette-Guerin (BCG) vaccine, and/or investigational Mycobacterium tuberculosis (Mtb) vaccine candidates. A major emphasis is placed on studying these responses in both HIV-infected and HIV-uninfected people, reflecting the real-world overlap between TB and HIV and the need for vaccines that work effectively in populations affected by HIV.
The FOA is designed to encourage innovative, high-risk, high-impact work, meaning applicants are expected to propose creative approaches that can open new directions rather than incremental extensions of established findings. The research goals are explicitly tied to understanding immune mechanisms that correlate with, contribute to, or are required for protection against Mtb. This includes mechanisms that prevent initial infection, prevent reinfection, and prevent progression from latent TB infection to active disease. In practice, the announcement is aiming to stimulate studies that can distinguish immune features of people who resist infection despite exposure, those who control infection without developing disease, and those who progress to active TB, and then translate those findings into actionable vaccine design ideas.
A key point in the announcement is the interest in both innate immunity (early, non-specific or broadly tuned defenses such as myeloid cell function, inflammatory pathways, trained immunity, and early cytokine and chemokine signaling) and adaptive immunity (T cell and B cell responses, quality and durability of immune memory, functional properties such as polyfunctionality, cytotoxic capacity, tissue homing, and antibody-mediated effects). Because HIV can reshape immune architecture, deplete or dysfunctionally skew CD4 T cells, and alter immune activation states, studies that directly compare or integrate HIV-infected and uninfected cohorts are particularly relevant for teasing apart which protective mechanisms are robust, which are compromised, and which can be restored or bypassed by vaccination strategies.
The expected payoff is data that can generate and strengthen hypotheses about what protective immunity against TB looks like in humans, which remains one of the major challenges in TB vaccine development. Rather than focusing only on whether a vaccine "works," the FOA emphasizes understanding why it works or fails by identifying immune signatures, pathways, and functional responses associated with protection. Findings supported under this announcement are intended to inform rational vaccine design, including selection of antigens, adjuvants, delivery platforms, dosing regimens, and target populations. Importantly, the FOA highlights relevance to populations that also carry HIV, so outputs that clarify immune requirements and constraints in HIV infection can help guide vaccines that are effective and safe in those higher-risk groups.
From an administrative standpoint, this is an R01 research grant mechanism under the U.S. Department of Health and Human Services, National Institutes of Health (listed as HHS-NIH11). The activity category is health, associated with CFDA numbers 93.855 and 93.856. Eligibility is broad and includes many organization types such as federal-recognized tribal governments and other tribal organizations, state and local governments, public and private institutions of higher education, independent school districts, special district governments, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), public housing authorities/Indian housing authorities, for-profit organizations (other than small businesses), and small businesses, along with other eligible applicants as described in NIH policy and the announcement text. The FOA was posted May 11, 2016, with a listed closing date of September 6, 2018 (both original and current closing dates shown as the same in the source data). The source data does not specify an award ceiling or the expected number of awards.
Overall, the opportunity is framed around a straightforward scientific mission: produce human immunology insights about responses to mycobacteria, BCG, and TB vaccine candidates, explicitly accounting for HIV status, so that the field can move closer to defining protective immune mechanisms and translating them into better, more broadly effective TB vaccines.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is an NIH Funding Opportunity Announcement (FOA) titled "Mechanisms of Mycobacterial-Induced Immunity in HIV-Infected and Uninfected Individuals to Inform Tuberculosis Vaccine Design (R01)", FOA number PAR-16-254. It supports research intended to advance tuberculosis (TB) vaccine development by clarifying how the human immune system responds to mycobacteria.
What is the main scientific goal of the FOA?
The central goal is to identify and dissect innate and adaptive immune responses in humans that are triggered by natural mycobacterial infection, the Bacillus Calmette-Guerin (BCG) vaccine, and/or investigational Mycobacterium tuberculosis (Mtb) vaccine candidates, and to use those insights to inform rational TB vaccine design.
Why does the FOA emphasize studying both HIV-infected and HIV-uninfected individuals?
The FOA highlights the real-world overlap between TB and HIV and the need for vaccines that work effectively in populations affected by HIV. Because HIV can reshape immune function (including effects on CD4 T cells and overall immune activation), comparing HIV-infected and HIV-uninfected cohorts can help identify which protective mechanisms are robust, which are compromised, and which may be restored or bypassed through vaccination strategies.
What types of immune responses are of interest under this FOA?
The FOA is interested in both:
- Innate immunity, including myeloid cell function, inflammatory pathways, trained immunity, and early cytokine/chemokine signaling.
- Adaptive immunity, including T cell and B cell responses, the quality and durability of immune memory, and functional properties such as polyfunctionality, cytotoxic capacity, tissue homing, and antibody-mediated effects.
What kinds of mycobacterial exposures or interventions can be studied?
The FOA explicitly mentions research focused on immune responses triggered by natural mycobacterial infection, the BCG vaccine, and/or investigational Mtb vaccine candidates.
How does this FOA define impact for TB vaccine development?
Impact is framed around producing human immunology insights that help define protective immunity against Mtb. Rather than only asking whether a vaccine works, the FOA emphasizes understanding why it works or fails by identifying immune signatures, pathways, and functional responses associated with protection, and translating those findings into actionable vaccine design ideas.
What protection-related outcomes does the FOA want investigators to address?
The FOA ties research goals to immune mechanisms that correlate with, contribute to, or are required for protection against Mtb, including mechanisms that:
- Prevent initial infection
- Prevent reinfection
- Prevent progression from latent TB infection to active TB disease
Does the FOA encourage particular study comparisons between groups?
Yes. The FOA aims to stimulate studies that can distinguish immune features among people who:
- Resist infection despite exposure
- Control infection without developing disease
- Progress to active TB
It also places a major emphasis on examining these patterns in both HIV-infected and HIV-uninfected individuals.
Is this FOA focused on incremental research or more novel approaches?
The FOA is designed to encourage innovative, high-risk, high-impact work. Applicants are expected to propose creative approaches that can open new directions rather than incremental extensions of established findings.
What kinds of outputs are expected to inform vaccine design?
Findings supported under this FOA are intended to inform rational vaccine design, including guidance relevant to:
- Selection of antigens
- Choice of adjuvants
- Delivery platforms
- Dosing regimens
- Target populations (including populations affected by HIV)
Which agency and mechanism are associated with this opportunity?
This is an NIH opportunity under the U.S. Department of Health and Human Services (HHS-NIH11), using the R01 research grant mechanism.
What is the activity category for this opportunity?
The activity category is Health.
What CFDA numbers are listed for this FOA?
The FOA lists CFDA numbers 93.855 and 93.856.
Who is eligible to apply based on the information provided?
Eligibility is described as broad and includes many organization types, including:
- Federal-recognized tribal governments and other tribal organizations
- State and local governments
- Public and private institutions of higher education
- Independent school districts
- Special district governments
- Nonprofit organizations (including 501(c)(3) and non-501(c)(3))
- Public housing authorities/Indian housing authorities
- For-profit organizations (other than small businesses)
- Small businesses
- Other eligible applicants as described in NIH policy and the FOA text
When was the FOA posted and what is the closing date listed?
The FOA was posted on May 11, 2016. The listed closing date is September 6, 2018 (the source data indicates both original and current closing dates as the same).
Does the provided information list an award ceiling or the expected number of awards?
No. The source data provided does not specify an award ceiling or the expected number of awards.
What is the overarching rationale behind this FOA?
The opportunity is built around a clear mission: generate human immunology insights about responses to mycobacteria, BCG, and TB vaccine candidates while explicitly accounting for HIV status. The aim is to move the field closer to defining protective immune mechanisms and translating those mechanisms into better and more broadly effective TB vaccines.
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