Research Projects to Improve the Predictive Value of Animal Models in Recapitulating Human Immunity to Influenza Infection and Vaccination (R21 Clinical Trial Not Allowed) | PAR 19 247

Frequently Asked Questions (FAQs): NIH PAR-19-247 (R21) - Improving Animal Models of Influenza Immunity

1. What is this funding opportunity (PAR-19-247) about?

PAR-19-247 is a National Institutes of Health (NIH) funding opportunity that supports exploratory research to improve existing animal models or create new animal models that more faithfully reflect how humans develop immunity to influenza through infection and vaccination.

2. What is the main goal of the FOA?

The core goal is to increase the predictive value of preclinical influenza models, meaning the animal model should do a better job forecasting what will happen in people when a new vaccine strategy is tested.

3. Why does NIH emphasize "predictive value" for these models?

NIH is aiming to reduce the gap between animal results and human outcomes. Traditional influenza animal models can be useful, but they may not capture key features of human immune responses, which can lead to preclinical findings that do not translate well when candidate vaccines move toward human evaluation.

4. What kinds of vaccines is this FOA particularly trying to support?

A major emphasis is on enabling more reliable evaluation of next-generation and "universal" influenza vaccines, especially where traditional models may not adequately capture the complexity of human immune responses.

5. What award mechanism is used for this opportunity?

This FOA uses the NIH R21 mechanism, which typically supports early-stage, proof-of-concept, high-impact exploratory research rather than large, multi-year development programs.

6. What does it mean that this is an R21?

Based on the information provided, the R21 framing signals that the funding is meant to catalyze innovative, exploratory approaches in influenza animal modeling that could later be expanded through larger mechanisms if successful.

7. Are clinical trials allowed under this opportunity?

No. The FOA is explicitly labeled "Clinical Trial Not Allowed," so funded work must remain non-clinical and cannot involve testing an intervention in human participants as a clinical trial.

8. Does "Clinical Trial Not Allowed" mean no work with humans at all?

The provided description states that funded work must remain non-clinical and cannot test an intervention in human participants as a clinical trial. The focus is on animal-based systems and related experimental, immunological, and methodological advances to improve model relevance to human influenza immunity.

9. What kinds of research activities does NIH want to fund?

The FOA supports exploratory research that improves existing animal models or creates new animal models to better mirror human influenza immunity. This includes advances needed to make animal systems more representative of human immune development following influenza infection and vaccination.

10. What scientific gap is this FOA trying to close?

It targets the mismatch between animal immune responses and human immune responses. Human influenza immunity is shaped by repeated exposures across a lifetime, prior infections, prior vaccinations, exposure to diverse strains, age-related immune changes, and other host factors that many conventional models do not reproduce well.

11. What are examples of model improvements this FOA encourages (based on the description)?

The description highlights several directions, such as better ways to model pre-existing immunity, more realistic exposure histories, improved readouts that align with human immune markers, and species/model refinements that more closely match human immunology.

12. What is meant by "pre-existing immunity" in this context?

In the context provided, it refers to the immune background humans have from previous influenza infections and vaccinations over time, which can strongly influence responses to later exposures and vaccines. The FOA encourages approaches that make animal models better reflect this reality.

13. Why is modeling realistic exposure histories important for influenza?

The opportunity description notes that human immunity is shaped by repeated exposures to influenza through infection and vaccination. If animal models do not reflect those histories, they may not predict how humans respond to new vaccine strategies, especially universal vaccine approaches.

14. What are "readouts that align with human immune markers"?

As described, these are measurements and evaluation methods in animals that map more directly to the immune markers used to understand human influenza immunity, with the goal of improving translation from preclinical studies to expected human outcomes.

15. What is the intended end result NIH is aiming for?

NIH is aiming for a preclinical toolbox that can more accurately rank, de-risk, and optimize candidate universal influenza vaccines before they advance toward human studies.

16. What is the funding instrument and agency for this opportunity?

This is an NIH discretionary grant opportunity using a grant funding instrument.

17. What is the health research category (CFDA) listed for this FOA?

The FOA sits in the health research category identified as CFDA 93.855.

18. What is the award ceiling for this opportunity?

The listed award ceiling is $200,000, described as a relatively small but targeted budget intended to catalyze innovative approaches.

19. What does the $200,000 ceiling imply about project scope?

Based on the description provided, the ceiling suggests the program is oriented toward targeted, proof-of-concept or high-impact exploratory work rather than large-scale, long-term development efforts.

20. When was this opportunity created and what closing date is shown?

The opportunity record was created on 2019-04-11. The original closing date shown in the provided source data is 2021-06-18.

21. Can this opportunity still be active if the closing date shown is in 2021?

The provided information notes the original closing date shown is 2021-06-18 and adds that similar opportunities may be reissued or updated later. Based on the information provided only, no current open/closed status beyond that date is stated.

22. Who is eligible to apply?

The FOA indicates broad eligibility. Eligible applicant types include academic and nonprofit research organizations, multiple levels of government entities (federal, state, county, city/township, special district), independent school districts, public housing authorities/Indian housing authorities, tribal governments and other tribal organizations, public and private institutions of higher education, 501(c)(3) and non-501(c)(3) nonprofits, for-profit organizations (other than small businesses) and small businesses, and other applicants as allowed.

23. Are tribal entities and tribal organizations eligible?

Yes. The eligibility list includes federally recognized Native American tribal governments as well as other tribal organizations.

24. Are minority-serving institutions specifically highlighted as eligible?

Yes. The announcement highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

25. Are faith-based or community-based organizations eligible?

Yes. The eligibility highlights include faith-based or community-based organizations.

26. Are U.S. territories or possessions included in eligibility?

Yes. The eligibility highlights include U.S. territories or possessions.

27. Can non-U.S. organizations apply?

Yes. The announcement explicitly notes that non-domestic (non-U.S.) entities/foreign organizations are included among eligible applicant categories.

28. Are for-profit organizations eligible?

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

29. What makes a project a good fit for this FOA, based on the description?

A strong fit is a non-clinical, animal-model-focused exploratory project that improves how well the model mirrors human influenza immunity, especially in ways that enhance the ability to evaluate next-generation and universal influenza vaccine strategies.

30. What is the overall purpose of this FOA in the broader vaccine development pipeline?

The FOA is designed to strengthen the non-clinical side of influenza vaccine development by improving animal models so preclinical studies can better guide which vaccine concepts to advance, how to optimize them, and how to reduce risk before moving toward human studies.