Opportunity Information: Apply for RFA DE 16 006
Apply for RFA DE 16 006
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Oral HIVacc Oral Mucosal Immunization Approaches for HIV Prevention (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 Aug 10, 2015 and posted on Aug 10, 2015.
- Applicants must submit their applications by Nov 23, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses Public housing authorities/Indian housing authorities City or township governments Special district governments State governments Public and State controlled institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts For profit organizations other than small businesses.
- 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 Oral HIVacc: Oral Mucosal Immunization Approaches for HIV Prevention (R01) funding opportunity (RFA-DE-16-006) is an NIH discretionary research grant that supports projects aimed at creating and evaluating new HIV vaccine approaches delivered directly to oral lymphoid tissues. The central idea behind the announcement is that vaccinating through specific immune tissues in the mouth could generate strong protection not only at the oral mucosa (a key barrier site) but also across the broader immune system, producing both local and systemic immune defenses. The FOA is positioned within the public health and biomedical research space under CFDA 93.121 (Oral Diseases and Disorders Research), reflecting a focus on oral and mucosal immunology as it relates to preventing HIV infection.
The FOA lays out a set of scientific objectives that applicants are expected to address through mechanistic and translational vaccine research. First, it seeks studies that define how direct immunization of oral lymphoid tissues activates oral innate immunity and drives adaptive immune responses locally and systemically. That includes understanding early innate signaling events, antigen uptake and presentation pathways, and how those processes shape downstream B cell and T cell responses. Second, it encourages work that determines how new or improved adjuvants, when paired with oral HIV vaccine candidates, strengthen the magnitude, quality, durability, and distribution of immune responses. This emphasis signals that NIH is interested not only in the vaccine antigen itself, but also in the immune "instructions" provided by adjuvants that could be especially important in mucosal tissues where tolerance and unique regulatory mechanisms can limit vaccine performance.
Third, the announcement calls for testing innovative oral vaccine vectors that express HIV vaccine antigens and can provoke protective immunity. In practice, this can include exploring vector platforms designed for mucosal delivery, evaluating how effectively they target oral lymphoid tissues, and measuring whether they elicit immune responses with properties associated with protection (for example, functional antibodies and tissue-relevant T cell responses). Fourth, the FOA explicitly supports comparative studies of oral mucosal immunization strategies and dosing schemes to identify approaches that maximize protection. This could involve comparing prime-boost regimens, alternative routes within the oral cavity, different formulations, or schedules intended to optimize mucosal and systemic immune outcomes. Fifth, it emphasizes delineating how oral and immune cell subsets change dynamically after oral vaccination, and how interactions among these cells influence the development of stronger immunity. This objective pushes applicants toward deeper immunophenotyping and systems-level analysis of mucosal immune ecology, including how cellular composition and activation states evolve over time following immunization.
From an administrative standpoint, the opportunity uses the R01 grant mechanism and does not require cost sharing or matching. The FOA was posted on August 10, 2015, with an original and current closing date of November 23, 2016, and an archive date of December 24, 2016. The estimated total funding amount listed is $2,000,000 for the opportunity as a whole. The sponsoring agency is the National Institutes of Health, and the full announcement was made available through the NIH Grants Guide (link provided in the source data).
Eligibility is broad and includes a wide range of domestic and non-domestic applicants. Eligible organizations include state, county, city/township, special district, and certain school district governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (including small businesses, and also for-profits other than small businesses); public housing authorities/Indian housing authorities; and Native American tribal governments and organizations, including federally recognized tribal governments and other tribal entities. The FOA also explicitly includes Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, faith-based and community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and foreign (non-U.S.) entities. Overall, the eligibility language suggests NIH wanted to enable participation from a diverse set of research performers capable of addressing oral mucosal vaccine science, including academic, governmental, nonprofit, and commercial groups.
In short, this FOA funds R01 research focused on oral mucosal HIV vaccination, with a strong emphasis on understanding mechanisms of immunity in oral lymphoid tissues, improving and characterizing adjuvants for mucosal use, developing and testing oral vaccine vectors, comparing immunization strategies to identify optimal regimens, and mapping the evolving oral immune cell landscape that drives protective responses. The goal is to advance oral-targeted HIV vaccine concepts that can generate robust local mucosal protection while also contributing to systemic immune defense.
Frequently Asked Questions (FAQs)
What is the Oral HIVacc funding opportunity?
Oral HIVacc: Oral Mucosal Immunization Approaches for HIV Prevention (R01) is an NIH research grant opportunity (RFA-DE-16-006) that supports projects developing and evaluating new HIV vaccine approaches delivered directly to oral lymphoid tissues (immune tissues in the mouth).
Who is the sponsoring agency for this grant?
The sponsoring agency is the National Institutes of Health (NIH). The full announcement was made available through the NIH Grants Guide.
What type of grant mechanism does this opportunity use?
This opportunity uses the NIH R01 research project grant mechanism.
What is the CFDA number and program area for this FOA?
The FOA is listed under CFDA 93.121, Oral Diseases and Disorders Research, reflecting its focus on oral and mucosal immunology in the context of HIV prevention.
What is the main scientific idea behind vaccinating through oral lymphoid tissues?
The central concept is that immunizing through specific immune tissues in the mouth may generate strong protection at the oral mucosa (a key barrier site) while also producing broader systemic immune defenses.
What overall research focus is NIH funding through this FOA?
The FOA funds mechanistic and translational research aimed at advancing oral mucosal HIV vaccine strategies, including how oral immune tissues respond to vaccination, how to strengthen those responses, and how different oral immunization approaches compare in terms of protective immunity.
What kinds of immune responses are emphasized in the FOA?
The FOA emphasizes both local (oral mucosal) and systemic immune responses, including oral innate immune activation and downstream adaptive responses such as B cell and T cell immunity.
What specific objective related to innate immunity does the FOA call for?
Applicants are expected to study how direct immunization of oral lymphoid tissues activates oral innate immunity, including early innate signaling events and how those events influence later immune responses.
Does the FOA include expectations around antigen uptake and presentation?
Yes. The FOA explicitly includes defining antigen uptake and presentation pathways following direct immunization of oral lymphoid tissues and understanding how those pathways shape downstream adaptive responses.
What does the FOA say about adaptive immune responses?
The FOA calls for research on how oral immunization drives adaptive immune responses locally and systemically, including how oral vaccination shapes B cell and T cell responses.
Are adjuvants a major part of the opportunity?
Yes. A key objective is determining how new or improved adjuvants, paired with oral HIV vaccine candidates, can strengthen the magnitude, quality, durability, and distribution of immune responses.
Why does the FOA emphasize adjuvants for oral/mucosal vaccination?
The FOA highlights that vaccine performance in mucosal tissues can be limited by tolerance and other regulatory mechanisms, so adjuvants that provide effective immune "instructions" may be especially important for achieving strong mucosal and systemic responses.
Does the FOA support work on oral vaccine vectors?
Yes. The FOA calls for testing innovative oral vaccine vectors that express HIV vaccine antigens and are capable of provoking protective immunity.
What does "innovative oral vaccine vectors" mean in the context of this FOA?
In this FOA, it refers to vector platforms designed for mucosal delivery that can target oral lymphoid tissues, express HIV vaccine antigens, and induce immune responses with properties associated with protection (such as functional antibodies and tissue-relevant T cell responses).
Does the FOA encourage comparing different oral immunization strategies?
Yes. The FOA explicitly supports comparative studies of oral mucosal immunization strategies and dosing schemes to identify approaches that maximize protection.
What kinds of comparisons are suggested for immunization strategies and dosing?
The FOA notes comparisons could include prime-boost regimens, alternative routes within the oral cavity, different formulations, and schedules intended to optimize both mucosal and systemic immune outcomes.
Is immune cell profiling and systems-level analysis part of the FOA?
Yes. One of the stated objectives is to delineate how oral and immune cell subsets change dynamically after oral vaccination and how interactions among these cells influence the development of stronger immunity.
What does the FOA mean by mapping dynamic changes in oral immune cell subsets?
It refers to characterizing how the cellular composition and activation states in oral and related immune compartments evolve over time following immunization, and analyzing how those changes correlate with stronger protective responses.
What is the estimated total funding amount for this opportunity?
The estimated total funding amount listed for the opportunity as a whole is $2,000,000.
Is cost sharing or matching required?
No. The FOA states that cost sharing or matching is not required.
When was this FOA posted?
The FOA was posted on August 10, 2015.
What is the closing date for this FOA?
The original and current closing date listed is November 23, 2016.
When was the archive date for this FOA?
The archive date listed is December 24, 2016.
What types of organizations are eligible to apply?
Eligibility is broad and includes domestic and non-domestic applicants across many organization types, including government entities, higher education institutions (public and private), nonprofits (with and without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), public housing/Indian housing authorities, tribal governments and organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and foreign entities.
Are state and local governments eligible?
Yes. The FOA includes eligibility for state, county, city/township, special district, and certain school district governments.
Are colleges and universities eligible?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are both included as eligible applicants.
Are nonprofit organizations eligible?
Yes. The FOA includes nonprofits with 501(c)(3) status (other than institutions of higher education) and nonprofits without 501(c)(3) status (other than institutions of higher education).
Are for-profit organizations eligible?
Yes. For-profit organizations are eligible, including small businesses and for-profits other than small businesses.
Are tribal governments and tribal organizations eligible?
Yes. The FOA includes Native American tribal governments and organizations, including federally recognized tribal governments and other tribal entities, as well as tribally controlled colleges and universities.
Are minority-serving institutions explicitly included?
Yes. The FOA explicitly includes Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), and tribally controlled colleges and universities.
Are faith-based and community-based organizations eligible?
Yes. The FOA explicitly includes faith-based and community-based organizations among eligible applicants.
Are foreign (non-U.S.) entities eligible to apply?
Yes. The FOA indicates that foreign (non-U.S.) entities are eligible.
What does "discretionary research grant" mean here?
In this context, the FOA describes the award as an NIH discretionary research grant that supports research projects aligned with the scientific objectives described in the announcement.
What kinds of outcomes is this FOA aiming to advance?
The FOA aims to advance oral-targeted HIV vaccine concepts that can generate robust local mucosal protection at the oral barrier while also contributing to systemic immune defense.
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