Opportunity Information: Apply for RFA DE 16 002
Apply for RFA DE 16 002
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Oral Immune System Plasticity in Chronic HIV Infection Under Treatment and Oral Co Infections (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121 Oral Diseases and Disorders Research.
- This funding opportunity was created on Apr 2, 2015 and posted on Apr 2, 2015.
- Applicants must submit their applications by Oct 29, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,353,000.00 to eligible and selected applicants.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Special district governments Independent school districts Private institutions of higher education County 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 Public housing authorities/Indian housing authorities.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The NIH grant opportunity "Oral Immune System Plasticity in Chronic HIV Infection Under Treatment and Oral Co-Infections (R01)" (Funding Opportunity Number RFA-DE-16-002) invited research projects focused on how the oral immune system changes, adapts, and sometimes fails to fully recover in people living with chronic HIV who are receiving combination antiretroviral therapy (cART) and who also experience oral opportunistic infections. The core idea behind the announcement is that even when HIV is clinically controlled by effective therapy, immune dysfunction and inflammation can persist in the mouth, shaping vulnerability to oral infections and allowing both HIV and other microbes to persist in tissue reservoirs. The FOA sought mechanistic, hypothesis-driven studies that explain why these oral problems continue or reappear under treatment and how the oral immune environment might be pushed back toward a healthier, more protective state.
A central theme of the FOA is "plasticity" of the oral immune system, meaning the capacity of oral immune cells and tissues to be remodeled by chronic infection, therapy, microbial exposures, and inflammatory signals. The announcement encouraged investigators to examine several related biological processes: reversal (or incomplete reversal) of immune activation after cART, the persistence of residual inflammation despite viral suppression, immune reconstitution inflammatory syndrome (IRIS) as it manifests in oral tissues, and microbial and microbial by-product translocation. In practical terms, this means studying how bacteria, fungi, viruses, or their inflammatory components can move across disrupted oral mucosal barriers, trigger immune activation, and maintain a cycle of inflammation that may not resolve even when systemic HIV viral loads are controlled. The FOA framed these issues as particularly relevant for individuals with HIV who develop oral opportunistic infections, where the mouth becomes both a site of clinical disease and a window into broader immune recovery problems.
The ultimate goals were twofold. First, NIH aimed to generate clearer knowledge about the pathogenesis and persistence of these oral conditions in treated chronic HIV infection, including why certain oral infections emerge, recur, or become chronic, and what immune pathways keep them going. Second, the FOA emphasized translational direction: using the mechanistic findings to inform development of novel oral immune modulatory approaches. The intent was not simply to describe immune abnormalities, but to identify actionable targets that could help rebuild or recalibrate oral immunity, reverse disease processes, slow or prevent progression, reduce the likelihood of these conditions occurring in the first place, and address persistence of residual HIV and other oral pathogens in anatomical reservoirs.
From an administrative standpoint, this was an R01 discretionary grant opportunity under the NIH mission area tied to oral diseases and disorders research (CFDA 93.121). The announcement was posted April 2, 2015, with an original and final closing date of October 29, 2015, and an archive date of November 29, 2015. NIH listed an estimated total funding level of $1,353,000 for the opportunity. Cost sharing or matching was not required, which is typical for many NIH research project grants. The FOA was broad in who could apply, encompassing many categories of domestic applicants (including public and private institutions of higher education, nonprofits with or without 501(c)(3) status, state and local governments, tribal governments and organizations, school districts, public housing authorities, and for-profit entities including small businesses). It also explicitly included additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, faith-based or community-based organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations) and regional organizations, reflecting NIH's openness to a wide research community where expertise is available.
In short, the FOA targeted a specific gap in HIV research: the oral compartment as an immunologically complex site where clinical problems persist even during otherwise successful systemic HIV treatment. By prioritizing mechanistic studies of immune activation, residual inflammation, IRIS, and microbial translocation in the setting of oral opportunistic infections, the announcement aimed to move the field toward therapies that do more than suppress HIV systemically, instead actively restoring oral immune function and reducing persistent microbial and viral reservoirs that contribute to ongoing disease burden.
Frequently Asked Questions (FAQs)
What is the official title of this NIH funding opportunity?
The funding opportunity is titled "Oral Immune System Plasticity in Chronic HIV Infection Under Treatment and Oral Co-Infections (R01)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-DE-16-002.
What type of NIH grant mechanism is being used?
This opportunity uses the NIH R01 mechanism, described as an R01 discretionary grant opportunity.
What research area is this opportunity connected to?
The FOA is tied to research on oral diseases and disorders and focuses on oral immune dysfunction in the setting of chronic HIV infection under combination antiretroviral therapy (cART), especially when oral opportunistic infections are present.
What is the central scientific focus of the FOA?
The core focus is how the oral immune system changes (its "plasticity"), adapts, and sometimes fails to fully recover in people living with chronic HIV who are receiving cART and who also experience oral opportunistic infections.
Why does the FOA focus on people with HIV who are already receiving effective therapy?
The FOA is based on the idea that even when HIV is clinically controlled by effective therapy, immune dysfunction and inflammation can persist in the mouth. This persistent oral immune disruption may increase vulnerability to oral infections and allow HIV and other microbes to persist in tissue reservoirs.
What does "plasticity" mean in the context of the oral immune system?
In this FOA, "plasticity" refers to the capacity of oral immune cells and tissues to be remodeled by chronic infection, therapy, microbial exposures, and inflammatory signals. It includes the possibility of reversal of immune activation, incomplete reversal, and longer-term remodeling that may either help restore protection or contribute to chronic inflammation and disease.
What kinds of studies were encouraged: descriptive or mechanistic?
The FOA sought mechanistic, hypothesis-driven studies. The intent was to explain why oral immune problems continue or reappear under treatment and identify immune pathways and targets that can be acted on, rather than only describing abnormalities.
What specific biological processes did the FOA encourage investigators to examine?
The announcement encouraged examination of: reversal (or incomplete reversal) of immune activation after cART, persistence of residual inflammation despite viral suppression, immune reconstitution inflammatory syndrome (IRIS) as it manifests in oral tissues, and microbial and microbial by-product translocation.
How does microbial translocation relate to oral disease in treated HIV, according to the FOA?
The FOA highlights that bacteria, fungi, viruses, or their inflammatory components can move across disrupted oral mucosal barriers. This movement can trigger immune activation and sustain a cycle of inflammation that may not resolve even when systemic HIV viral loads are controlled.
What is the role of oral opportunistic infections in the FOA's rationale?
Oral opportunistic infections are positioned as a key context where persistent immune dysfunction becomes clinically visible. The FOA treats the mouth as both a site of disease and a window into broader problems of immune recovery in treated chronic HIV infection.
What is the FOA trying to explain about oral infections in treated chronic HIV?
It aims to clarify why certain oral infections emerge, recur, or become chronic even during cART, and to identify the immune pathways and inflammatory drivers that enable these conditions to persist.
What are the two overarching goals of the FOA?
The goals are (1) to generate clearer knowledge about the pathogenesis and persistence of oral conditions in treated chronic HIV infection, and (2) to use mechanistic findings to inform the development of novel oral immune modulatory approaches.
Is the FOA focused on developing interventions, or only on basic mechanisms?
It emphasizes a translational direction: mechanistic insights should inform novel oral immune modulatory approaches. The intent is to identify actionable targets that could help rebuild or recalibrate oral immunity and reduce disease burden and microbial/viral persistence in reservoirs.
What kinds of outcomes or impacts did NIH want these projects to ultimately support?
Based on the FOA description, NIH wanted research that could help reverse disease processes, slow or prevent progression, reduce the likelihood of oral conditions occurring in the first place, and address persistence of residual HIV and other oral pathogens in anatomical reservoirs.
What is meant by "residual inflammation" in this FOA?
Residual inflammation refers to ongoing inflammatory activity that remains despite viral suppression achieved with cART. The FOA frames this as a contributor to continued oral immune dysfunction and susceptibility to oral co-infections.
Does the FOA specifically mention IRIS in the oral compartment?
Yes. The FOA explicitly calls out immune reconstitution inflammatory syndrome (IRIS) as it manifests in oral tissues as one of the processes investigators were encouraged to study.
How is the oral compartment described in relation to HIV persistence?
The FOA describes the mouth as an immunologically complex site where both HIV and other microbes can persist in tissue reservoirs, even when systemic HIV is controlled by therapy.
What is the CFDA number associated with this opportunity?
The CFDA listing provided for this opportunity is 93.121.
When was the FOA posted?
The announcement was posted on April 2, 2015.
What were the original and final closing dates for applications?
The FOA lists an original closing date and a final closing date of October 29, 2015.
When was the archive date?
The archive date listed is November 29, 2015.
How much total funding did NIH estimate for this opportunity?
NIH listed an estimated total funding level of $1,353,000 for the opportunity.
Was cost sharing or matching required?
No. The FOA states that cost sharing or matching was not required.
Who was eligible to apply?
The FOA was broad in eligibility. It included many categories of domestic applicants such as public and private institutions of higher education, nonprofits with or without 501(c)(3) status, state and local governments, tribal governments and organizations, school districts, public housing authorities, and for-profit entities including small businesses.
Did the FOA include eligibility for specific institution types like HBCUs and HSIs?
Yes. It explicitly included additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, and faith-based or community-based organizations.
Were U.S. territories and possessions eligible?
Yes. The FOA explicitly included U.S. territories or possessions among eligible applicants.
Were non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA explicitly included non-U.S. entities (foreign organizations) and regional organizations as eligible applicants.
What kinds of organizations beyond universities could apply?
Based on the FOA text, eligible applicants included governments (state, local, and tribal), school districts, public housing authorities, nonprofits (with or without 501(c)(3) status), for-profit entities including small businesses, faith-based or community-based organizations, and others listed.
What gap in HIV research was this FOA trying to address?
It targeted the gap that the oral compartment can remain a site of persistent immune dysfunction and clinical problems even during otherwise successful systemic HIV treatment, and that this compartment may harbor persistent microbial and viral reservoirs.
How does the FOA describe the relationship between systemic viral suppression and oral disease?
It suggests that systemic viral suppression does not necessarily mean full immune recovery in the mouth. Persistent inflammation and immune dysfunction in oral tissues may continue and contribute to recurrent or chronic oral opportunistic infections.
What distinguishes the oral compartment in this FOA's framing?
The FOA frames the mouth as a distinct, immunologically complex environment where chronic infection, therapy effects, microbial exposures, barrier disruption, and inflammatory signaling can interact in ways that may not fully normalize with systemic treatment.
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