Opportunity Information: Apply for RFA DE 10 001
Apply for RFA DE 10 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Oral Mucosal Vaccination against HIV Infection (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 Jul 7, 2009 and posted on Jul 7, 2009.
- Applicants must submit their applications by Dec 2, 2009. (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: Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Small businesses Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal 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 For profit organizations other than small businesses.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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 Mucosal Vaccination against HIV Infection (R01) funding opportunity (RFA-DE-10-001) is an NIH National Institute of Dental and Craniofacial Research (NIDCR) call for research project grant applications focused on developing preventive (prophylactic) HIV vaccines that are delivered through the oral mucosa. The central idea is to take advantage of the unique immune environment of the mouth, especially oral mucosal immunity and innate immune defenses, to generate protective anti-HIV responses that can also translate into strong systemic adaptive immunity. Rather than treating the oral cavity as just a delivery route, this FOA treats it as an active immunological site where early immune events, local cell interactions, and oral secretions could be leveraged to shape broader protection.
Scientifically, NIDCR is looking for R01 projects that tackle specific, fairly targeted questions about how oral immunity can be engaged to prevent HIV infection. Priority areas include explaining the mechanisms that connect oral mucosal and innate immune responses to downstream systemic adaptive immunity (for example, how local antigen presentation and innate signaling in oral tissues influences T and B cell responses throughout the body). Another major emphasis is on developing vaccine antigens and formulations suitable for oral mucosal delivery, including oral expression vectors or platforms that can remain stable in the oral cavity long enough to be immunologically meaningful and that can trigger measurable protective immune responses against HIV. The FOA also highlights interest in understanding how HIV interacts with potential target cells in the oral cavity, including epithelial and immune cell populations, and how key innate immune cell subsets such as dendritic cells (DCs) and natural killer (NK) cells change during HIV disease progression or in response to oral mucosal vaccination.
A notable theme throughout the announcement is the biology of DC-NK cell cross talk in the oral environment. Applicants are encouraged to study how DC and NK cells communicate locally in oral tissues after vaccination and how that local interaction relates to systemic adaptive immunity. NIDCR also invites comparative work that examines how these DC-NK interactions in the oral mucosa are similar to or different from those at other mucosal sites, which can help clarify what is unique about the oral cavity as an immunization target. In addition, the FOA calls for characterization of soluble defense molecules found in oral secretions after oral mucosal HIV vaccination, which could include innate antimicrobial factors, cytokines, chemokines, and other mediators that might serve as correlates of protection or mechanistic readouts of vaccine activity.
In terms of project maturity, this opportunity is geared toward advancing vaccine concepts that already have defined target antigens or model antigens and are ready for further development in the context of oral delivery. It explicitly welcomes studies that focus on improving vaccine formulations and delivery strategies for the oral cavity, validating targets, and conducting early preclinical evaluation in relevant animal models. At the same time, it draws clear boundaries around what it will not fund: it will not support basic discovery of new vaccine antigens (meaning early-stage antigen hunting), HIV vaccine clinical trials, therapeutic vaccine approaches (treating existing infection rather than preventing it), enteric vaccines intended for gastrointestinal targeting via oral delivery, or nasal delivery methods proposed as part of an oral mucosal HIV vaccine strategy.
Administratively, the mechanism is the standard NIH Research Project Grant (R01). NIDCR anticipated committing about $2,000,000 in total costs in fiscal year 2010 to support roughly 4 to 6 awards, with the usual caveat that final awards depend on available funds and the quality and number of applications received. The opportunity was posted July 7, 2009, with an original and current closing date of December 2, 2009, and it was archived January 2, 2010. The activity falls under CFDA 93.121 (Oral Diseases and Disorders Research), and there is no cost sharing or matching requirement.
Eligibility is broad and includes many organization types such as public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations), for-profit organizations (including small businesses), state governments, U.S. territorial entities, Native American tribal governments and organizations, and foreign (non-U.S.) entities and regional organizations. The FOA also explicitly notes inclusion of institutions serving specific populations, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and other tribal entities. Overall, the program is structured to attract multidisciplinary teams spanning oral biology, mucosal immunology, innate immunity, vaccinology, vector/formulation science, and relevant animal modeling, all aimed at building a credible, mechanistically grounded path toward an oral mucosal HIV vaccine.
FAQs: Oral Mucosal Vaccination against HIV Infection (R01) - RFA-DE-10-001
What is the Oral Mucosal Vaccination against HIV Infection (R01) opportunity?
This is an NIH National Institute of Dental and Craniofacial Research (NIDCR) funding opportunity for R01 research projects focused on developing preventive (prophylactic) HIV vaccines delivered through the oral mucosa. The program treats the oral cavity as an active immunological site, not just a delivery route, and supports studies that use oral mucosal immunity and innate defenses to drive protective anti-HIV responses, including strong systemic adaptive immunity.
What is the FOA number and title?
The funding opportunity is titled Oral Mucosal Vaccination against HIV Infection (R01) and the FOA is RFA-DE-10-001.
Which NIH institute is sponsoring this opportunity?
The sponsoring institute is the NIH National Institute of Dental and Craniofacial Research (NIDCR).
What grant mechanism is being used?
The mechanism is the NIH Research Project Grant (R01).
What is the overall scientific goal of this FOA?
The goal is to advance prophylactic HIV vaccine approaches specifically designed for oral mucosal delivery, while building a mechanistic understanding of how early immune events in oral tissues and oral secretions can shape protective local immunity and downstream systemic adaptive immune responses.
Why is the oral cavity a focus area for HIV vaccination in this FOA?
This FOA emphasizes that the mouth has a unique immune environment, including oral mucosal immunity and innate defenses. NIDCR is interested in leveraging local immune events, cell interactions, and soluble factors in oral secretions to generate protective anti-HIV responses and to promote strong systemic adaptive immunity.
What kinds of research questions are considered a priority?
Priority areas include targeted questions about how oral immunity can be engaged to prevent HIV infection, such as:
- Mechanisms linking oral mucosal and innate responses to downstream systemic adaptive immunity (including how local antigen presentation and innate signaling influence systemic T and B cell responses).
- Development and improvement of vaccine antigens and formulations appropriate for oral mucosal delivery.
- Understanding how HIV interacts with potential oral target cells (epithelial and immune cell populations).
- How key innate immune cell subsets, including dendritic cells (DCs) and natural killer (NK) cells, change during HIV disease progression or in response to oral mucosal vaccination.
What is meant by treating the oral cavity as an "active immunological site"?
In this FOA, the oral cavity is viewed as a place where early immune events matter. That includes local cell-to-cell interactions, innate signaling, antigen presentation in oral tissues, and the role of oral secretions in shaping immune responses that may extend beyond the mouth to systemic adaptive immunity.
Is this opportunity focused on preventive or therapeutic HIV vaccines?
It is focused on preventive (prophylactic) HIV vaccines. Therapeutic vaccine approaches (intended to treat existing infection) are explicitly not supported under this FOA.
Does the FOA support clinical trials for HIV vaccines?
No. HIV vaccine clinical trials are explicitly not supported under this FOA.
Does the FOA fund basic discovery of new HIV vaccine antigens?
No. The FOA does not support basic discovery efforts aimed at identifying brand-new vaccine antigens (early-stage antigen hunting). It is geared toward vaccine concepts that already have defined target antigens or model antigens.
What level of project maturity is NIDCR looking for?
The opportunity is geared toward advancing vaccine concepts that already have defined target antigens or model antigens and are ready for further development specifically in the context of oral delivery. It welcomes work on improving formulations and delivery strategies, validating targets, and early preclinical evaluation in relevant animal models.
What types of vaccine platforms or formulations are of interest for oral mucosal delivery?
NIDCR is interested in vaccine antigens and formulations suitable for oral mucosal delivery, including oral expression vectors or platforms that can remain stable in the oral cavity long enough to be immunologically meaningful and that can trigger measurable protective immune responses against HIV.
Is stability in the oral cavity an important consideration?
Yes. The FOA specifically highlights interest in platforms and formulations that can remain stable in the oral cavity long enough to generate an immunologically meaningful response.
What immune mechanisms are especially emphasized?
A central emphasis is understanding the mechanisms that connect oral mucosal immunity and innate defenses to systemic adaptive immunity, including how local antigen presentation and innate signaling influence broader T and B cell responses.
What is the role of dendritic cells (DCs) and natural killer (NK) cells in this FOA?
The FOA places notable emphasis on the biology of DC-NK cell cross talk in the oral environment. Applicants are encouraged to study how DCs and NK cells communicate locally after oral mucosal vaccination and how those local interactions relate to downstream systemic adaptive immunity.
Does the FOA encourage comparisons between the oral mucosa and other mucosal sites?
Yes. Comparative work examining how DC-NK interactions in the oral mucosa are similar to or different from those at other mucosal sites is encouraged to help clarify what is unique about the oral cavity as an immunization target.
Does the FOA include research on oral secretions?
Yes. The FOA calls for characterization of soluble defense molecules found in oral secretions after oral mucosal HIV vaccination. Examples mentioned include innate antimicrobial factors, cytokines, chemokines, and other mediators that could serve as correlates of protection or mechanistic readouts of vaccine activity.
Does the FOA support studies of how HIV interacts with cells in the oral cavity?
Yes. The FOA highlights interest in understanding how HIV interacts with potential target cells in the oral cavity, including epithelial and immune cell populations.
Are animal model studies allowed or encouraged?
Yes. The FOA welcomes early preclinical evaluation in relevant animal models as part of advancing oral mucosal HIV vaccine concepts.
What is explicitly out of scope for this FOA?
The FOA explicitly excludes support for:
- Basic discovery of new vaccine antigens (early-stage antigen hunting)
- HIV vaccine clinical trials
- Therapeutic vaccine approaches (treating existing HIV infection)
- Enteric vaccines intended for gastrointestinal targeting via oral delivery
- Nasal delivery methods proposed as part of an oral mucosal HIV vaccine strategy
Does "oral delivery" include enteric (GI-targeted) vaccine approaches?
No. Enteric vaccines intended for gastrointestinal targeting via oral delivery are explicitly not supported.
Are nasal delivery approaches allowed if the overall project is about oral mucosal vaccination?
No. Nasal delivery methods proposed as part of an oral mucosal HIV vaccine strategy are explicitly not supported under this FOA.
How much funding did NIDCR plan to commit, and how many awards were expected?
NIDCR anticipated committing about $2,000,000 in total costs in fiscal year 2010 to support roughly 4 to 6 awards, with the standard caveat that final awards depend on available funds and the quality and number of applications received.
What are the key dates for this funding opportunity?
The opportunity was posted on July 7, 2009. The original and current closing date was December 2, 2009. The FOA was archived on January 2, 2010.
What is the CFDA number for this program?
The activity falls under CFDA 93.121, titled Oral Diseases and Disorders Research.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement stated for this opportunity.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations), for-profit organizations (including small businesses), state governments, U.S. territorial entities, Native American tribal governments and organizations, and foreign (non-U.S.) entities and regional organizations.
Are foreign organizations eligible to apply?
Yes. Foreign (non-U.S.) entities and regional organizations are included in the eligibility list.
Does the FOA mention organizations serving specific populations?
Yes. The FOA explicitly notes inclusion of institutions serving specific populations, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and other tribal entities.
What kinds of teams or expertise does NIDCR seem to be trying to attract?
The program is structured to attract multidisciplinary teams spanning oral biology, mucosal immunology, innate immunity, vaccinology, vector and formulation science, and relevant animal modeling, all aimed at building a credible, mechanistically grounded path toward an oral mucosal HIV vaccine.
Is the goal limited to local (oral) immunity, or does it also include systemic immunity?
It includes both. A central scientific theme is using oral mucosal and innate immune responses to generate protective anti-HIV responses that translate into strong systemic adaptive immunity.
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