Opportunity Information: Apply for RFA DE 18 008

The Oral HIV Vaccination: Strategy Synergistic to Systemic Vaccination (R01) funding opportunity (RFA-DE-18-008) is a National Institutes of Health (NIH) research grant solicitation that supports hypothesis-driven basic, translational, and pre-clinical studies aimed at preventing HIV infection. The central goal is to spur development of new prophylactic oral mucosal vaccine approaches that work in a complementary, synergistic way with systemic vaccination. In practical terms, this FOA is looking for research that strengthens protective immunity at oral mucosal surfaces (where exposure can occur) while also fitting into a broader vaccination strategy that generates systemic immune responses, with the expectation that combining mucosal and systemic approaches could provide stronger or more durable protection than either alone.

This announcement falls under the discretionary grant category and uses the R01 research project grant mechanism, which is typically designed for investigator-initiated projects with well-developed scientific aims and a clear experimental plan. The scientific scope emphasizes early-stage and preclinical development work rather than human efficacy trials, with a focus on understanding mechanisms, improving immunogen or platform design, optimizing delivery strategies, and generating the kind of preclinical evidence needed to justify future clinical translation. The topic focus is specifically oral mucosal vaccination in the context of HIV prevention, and the work is expected to be grounded in testable hypotheses rather than purely descriptive studies.

A wide range of organizations are eligible to apply. Eligible applicants include various levels of U.S. government entities (state, county, city/township, and special district governments), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, and Native American tribal governments (federally recognized) as well as other tribal organizations. The eligibility list also includes public housing authorities/Indian housing authorities, nonprofit organizations both with and without 501(c)(3) status (as long as they are not institutions of higher education), for-profit organizations (other than small businesses), and small businesses. In addition, the FOA explicitly highlights other eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also allows applications from eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations), signaling an intent to encourage broad participation and potentially international collaboration where scientifically appropriate.

From an administrative standpoint, the opportunity is associated with the Health funding activity category and CFDA number 93.121. The posting indicates an original closing date of November 24, 2017, and a creation date of February 13, 2017. The award ceiling and expected number of awards are not specified in the provided source details, which typically means applicants would need to consult the full FOA text or NIH budget guidance for any constraints, expectations, or institute-specific funding considerations.

Overall, the grant opportunity is best understood as NIH support for rigorous, hypothesis-driven vaccine research that specifically targets oral mucosal immunity as part of a combined mucosal-plus-systemic HIV vaccination strategy. Competitive applications would be expected to articulate why an oral mucosal approach is likely to add value beyond systemic vaccination alone, define clear mechanistic or developmental aims, and propose preclinical experiments that can meaningfully de-risk and advance the field toward an effective prophylactic HIV vaccine strategy.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Oral HIV Vaccination: Strategy Synergistic to Systemic Vaccination (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121.
  • This funding opportunity was created on 2017-02-13.
  • Applicants must submit their applications by 2017-11-24. (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.
Apply for RFA DE 18 008

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Frequently Asked Questions (FAQs)

1) What is the name and identifier of this funding opportunity?

The opportunity is titled Oral HIV Vaccination: Strategy Synergistic to Systemic Vaccination (R01) and is identified as RFA-DE-18-008.

2) Who is offering this grant?

This is a National Institutes of Health (NIH) research grant solicitation.

3) What is the overall purpose of this FOA?

The central purpose is to support hypothesis-driven research that advances new prophylactic oral mucosal HIV vaccine approaches designed to work in a complementary, synergistic manner with systemic vaccination, with the goal of preventing HIV infection.

4) What is the main scientific emphasis of the program?

The program emphasizes strengthening protective immunity at oral mucosal surfaces (where exposure can occur) while fitting into a broader strategy that also induces systemic immune responses. The underlying idea is that combining mucosal and systemic approaches could provide stronger and/or more durable protection than either approach alone.

5) What type of research does this opportunity support?

It supports hypothesis-driven basic, translational, and pre-clinical studies aimed at HIV prevention. The scope highlights research that improves understanding of mechanisms and supports early-stage development needed to justify future clinical translation.

6) Is this opportunity intended for clinical efficacy trials in humans?

Based on the provided information, the emphasis is on early-stage and preclinical development rather than human efficacy trials.

7) What is meant by "oral mucosal vaccination" in this context?

In this FOA, oral mucosal vaccination refers to strategies intended to build protective immune responses at oral mucosal surfaces, which are relevant sites of potential HIV exposure, and to do so as part of a broader combined mucosal-plus-systemic vaccination strategy.

8) What does "synergistic to systemic vaccination" mean here?

It means the oral mucosal vaccine approach should be designed to add value when paired with systemic vaccination, creating a complementary combination that may enhance the strength and/or durability of protection compared with systemic vaccination alone.

9) What grant mechanism is being used?

This FOA uses the R01 research project grant mechanism.

10) What does an R01 imply about the kind of project expected?

An R01 is typically used for investigator-initiated projects with well-developed scientific aims and a clear experimental plan. For this FOA, that aligns with rigorous, testable, hypothesis-driven preclinical vaccine research.

11) Are descriptive studies appropriate for this FOA?

The FOA is described as expecting work to be grounded in testable hypotheses rather than purely descriptive studies.

12) What kinds of activities are specifically emphasized?

The description emphasizes work such as understanding mechanisms, improving immunogen or platform design, optimizing delivery strategies, and generating preclinical evidence that supports eventual clinical translation.

13) What is the funding activity category?

The opportunity is associated with the Health funding activity category.

14) What is the CFDA number associated with this opportunity?

The CFDA number listed for this opportunity is 93.121.

15) What type of grant category is this?

This announcement falls under the discretionary grant category.

16) Which organizations are eligible to apply?

The eligibility list provided is broad and includes:

  • U.S. government entities (state, county, city/township, and special district governments)
  • Independent school districts
  • Public and state-controlled institutions of higher education
  • Private institutions of higher education
  • Native American tribal governments (federally recognized) and other tribal organizations
  • Public housing authorities/Indian housing authorities
  • Nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education)
  • For-profit organizations (other than small businesses)
  • Small businesses
  • Eligible federal agencies
  • Faith-based or community-based organizations
  • U.S. territories or possessions
  • Regional organizations
  • Non-U.S. entities (foreign organizations)

17) Does the FOA specifically encourage applications from certain institution types?

Yes. The FOA explicitly highlights eligibility for categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).

18) Are foreign (non-U.S.) organizations eligible to apply?

Yes. The eligibility information states that non-U.S. entities (foreign organizations) are eligible.

19) Are for-profit entities eligible?

Yes. The eligibility list includes for-profit organizations (other than small businesses) and also includes small businesses.

20) Are nonprofit organizations eligible if they do not have 501(c)(3) status?

Yes. The eligibility list includes nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education).

21) When was this opportunity created?

The creation date listed is February 13, 2017.

22) What was the original closing date for applications?

The posting indicates an original closing date of November 24, 2017.

23) Is the award ceiling provided?

No. The award ceiling is not specified in the provided details.

24) Is the expected number of awards provided?

No. The expected number of awards is not specified in the provided details.

25) Where should applicants look for budget limits or other constraints?

The provided information indicates that applicants would typically need to consult the full FOA text or NIH budget guidance for constraints, expectations, or institute-specific funding considerations.

26) What would a competitive application generally need to explain?

Based on the description, competitive applications would be expected to:

  • Clearly state why an oral mucosal approach adds value beyond systemic vaccination alone
  • Define clear mechanistic or developmental aims
  • Propose preclinical experiments that meaningfully de-risk the approach and advance it toward future clinical translation

27) Is this FOA focused on prevention or treatment of HIV?

The FOA is focused on preventing HIV infection through prophylactic vaccine research.

28) What stage of development is most aligned with this FOA?

The scope aligns most strongly with basic-to-preclinical work, including translational and preclinical studies that generate evidence needed to support later clinical translation.

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