Opportunity Information: Apply for RFA AI 12 007
Apply for RFA AI 12 007
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Targeting Inflammation and Immune Activation in HIV Disease (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Jan 20, 2012 and posted on Jan 20, 2012.
- Applicants must submit their applications by Jul 13, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,300,000.00 to eligible and selected applicants.
- Eligible applicants include: For profit organizations other than small businesses Independent school districts Small businesses City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The NIH funding opportunity "Targeting Inflammation and Immune Activation in HIV Disease (U01)" (Funding Opportunity Number RFA-AI-12-007) is a discretionary cooperative agreement program aimed at advancing research on why chronic immune activation and persistent inflammation continue in people living with HIV even when antiretroviral therapy is fully suppressing the virus. The core idea is that many individuals on effective ART still show signs of ongoing immune system stimulation and inflammatory processes, which are believed to contribute to longer-term health complications. This FOA is designed to move beyond observation and directly test whether specific, well-justified interventions can dampen these processes and clarify the biological pathways driving them.
Projects are expected to be small, proof-of-concept clinical trials rather than large definitive efficacy studies. The clinical component must be paired with intensive, concurrent laboratory investigations, meaning applicants need to collect and analyze biologic samples in a way that can explain not only whether the intervention changes inflammation or immune activation, but also how it does so. A key requirement is that the intervention being tested must have a known mechanism of action. In practice, this pushes applicants to choose therapies or strategies where the molecular or cellular target is already understood, so that trial results can be interpreted mechanistically and used to pinpoint actionable pathways.
The overall goal of the initiative is highly translational: to identify specific mechanisms or pathways that can be targeted to prevent or reverse persistent immune activation in HIV-infected individuals on suppressive therapy. This implies an emphasis on biomarkers, immune phenotyping, inflammatory markers, and other readouts that can connect the intervention to defined immunologic or inflammatory processes. The expectation is that successful studies will generate clear signals about which targets are worth pursuing in larger trials and which biological pathways should be prioritized for future therapeutic development.
Administratively, this opportunity was issued by the National Institutes of Health, aligned with NIAID-related research areas reflected in CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The funding instrument is a U01 cooperative agreement, which generally indicates substantial NIH programmatic involvement compared with a typical investigator-initiated grant, often including coordination, milestone-driven progress, or active collaboration with NIH staff. The FOA did not require cost sharing or matching. The posting and creation date were January 20, 2012, with an original and current closing date of July 13, 2012, and an archive date of August 13, 2012. The estimated total funding amount listed was $2,300,000.
Eligibility was broad across U.S.-based organizations and government entities. Eligible applicants included for-profit organizations (including small businesses and other for-profits), nonprofits (including 501(c)(3) and non-501(c)(3) organizations), public and private institutions of higher education, independent school districts, and a range of local, county, state, and tribal government entities. The eligibility description also explicitly included organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. At the same time, the FOA clearly prohibited non-U.S. entities from applying: foreign institutions were not eligible, and non-domestic components of U.S. organizations were not eligible. Foreign components, as defined by the NIH Grants Policy Statement, were also not allowed.
For applicants or institutions needing the official announcement or help accessing it, the FOA provided an NIH Grants Guide link (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-007.html) and directed technical access issues to the NIH Office of Extramural Research (OER) webmaster contact (FBOWebmaster@OD.NIH.GOV).
Frequently Asked Questions (FAQs)
1) What is the title and funding opportunity number for this NIH grant?
The opportunity is titled "Targeting Inflammation and Immune Activation in HIV Disease (U01)" and the Funding Opportunity Number (FOA) is RFA-AI-12-007.
2) What is the purpose of this funding opportunity?
This FOA supports research to understand why chronic immune activation and persistent inflammation continue in people living with HIV even when antiretroviral therapy (ART) is fully suppressing the virus, and to directly test interventions intended to reduce (dampen) these processes.
3) What problem in HIV treatment is this FOA trying to address?
The FOA focuses on the observation that many individuals on effective, virus-suppressing ART still show ongoing immune system stimulation and inflammatory activity. These ongoing processes are believed to contribute to longer-term health complications, and the FOA aims to identify targetable mechanisms behind them.
4) What type of studies are expected under this FOA?
Projects are expected to be small, proof-of-concept clinical trials rather than large, definitive efficacy studies.
5) Does the FOA require laboratory research in addition to the clinical trial?
Yes. The clinical component must be paired with intensive, concurrent laboratory investigations. Applicants are expected to collect and analyze biologic samples in a way that helps explain not only whether the intervention changes inflammation or immune activation, but also how it does so.
6) What does "mechanism of action" mean in the context of this FOA?
A key requirement is that the intervention being tested must have a known mechanism of action. In practical terms, the therapy or strategy should have an already understood molecular or cellular target so that trial results can be interpreted mechanistically and used to pinpoint actionable pathways.
7) Is this FOA mainly observational, or does it support interventional research?
It is designed to move beyond observation and directly test well-justified interventions intended to reduce persistent immune activation and inflammation in HIV disease during suppressive ART.
8) What kinds of outcomes or measurements does this FOA emphasize?
The FOA implies an emphasis on translational readouts such as biomarkers, immune phenotyping, inflammatory markers, and other measures that can connect the tested intervention to defined immunologic or inflammatory processes.
9) What is the overall goal or expected impact of funded projects?
The overall goal is to identify specific mechanisms or pathways that can be targeted to prevent or reverse persistent immune activation in HIV-infected individuals on suppressive therapy. Successful studies are expected to generate clear signals about which targets should be prioritized for future, larger trials and therapeutic development.
10) What is the funding instrument used for this opportunity?
The funding instrument is a U01 cooperative agreement.
11) What does it mean that this is a U01 cooperative agreement?
A U01 cooperative agreement generally indicates substantial NIH programmatic involvement compared with a typical investigator-initiated grant. This often includes coordination, milestone-driven progress, or active collaboration with NIH staff.
12) Which NIH organization issued this funding opportunity?
The opportunity was issued by the National Institutes of Health (NIH) and is aligned with NIAID-related research areas.
13) What CFDA numbers are associated with this FOA?
The FOA references CFDA 93.855 (Allergy and Infectious Diseases Research) and CFDA 93.856 (Microbiology and Infectious Diseases Research).
14) How much total funding was estimated for this FOA?
The estimated total funding amount listed was $2,300,000.
15) Does this FOA require cost sharing or matching funds?
No. The FOA did not require cost sharing or matching.
16) When was this FOA posted and when did it close?
The posting/creation date was January 20, 2012. The original and current closing date was July 13, 2012. The archive date was August 13, 2012.
17) Is this funding opportunity still open?
No. Based on the closing date (July 13, 2012) and archive date (August 13, 2012), this FOA is not currently open.
18) Who was eligible to apply?
Eligibility was broad across U.S.-based organizations and government entities. Eligible applicants included for-profit organizations (including small businesses and other for-profits), nonprofits (including 501(c)(3) and non-501(c)(3) organizations), public and private institutions of higher education, independent school districts, and local/county/state/tribal government entities.
19) Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The eligibility description explicitly included organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, and regional organizations.
20) Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions were explicitly included among eligible applicants.
21) Are federal agencies eligible to apply?
Yes. Eligible federal agencies were included in the eligibility description.
22) Are foreign institutions eligible to apply?
No. The FOA prohibited non-U.S. entities from applying. Foreign institutions were not eligible.
23) Can a U.S. organization include a non-domestic component on an application?
No. Non-domestic components of U.S. organizations were not eligible under this FOA.
24) Are foreign components allowed in any form?
No. Foreign components (as defined by the NIH Grants Policy Statement) were not allowed.
25) Where can applicants find the official FOA announcement?
The FOA provided an NIH Grants Guide link: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-007.html
26) Who should be contacted for technical issues accessing the FOA?
Technical access issues were directed to the NIH Office of Extramural Research (OER) webmaster contact: FBOWebmaster@OD.NIH.GOV
27) What is the central scientific theme tying projects together under this FOA?
The central theme is translational, mechanistic research that tests interventions with known targets in order to determine whether and how persistent inflammation and immune activation can be reduced in people living with HIV whose virus is suppressed on ART.
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