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Partnerships for the Development of Universal Influenza Vaccines (R21/R33 Clinical Trial Not Allowed)

Grants to USA, Canada, and International Nonprofits, Educational
Institutions, Agencies, and For-Profits for Vaccine Research Projects

Agency Type:

Federal

Funding Source:

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National Institutes of Health (NIH) - National Institute of Allergy and Infectious Diseases (NIAID)

Deadline Date:

07/02/20 5:00 PM Local Time

Description:

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Grants to USA, Canada, and International nonprofit organizations, IHEs, schools, government agencies, and for-profits for scientific research to develop vaccines. Applicants are advised that required registrations may take several weeks to complete. The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to support the development of promising universal influenza vaccine candidates that protect against both influenza A and B viruses. For this RFA, the NIAID is only accepting applications that do not propose clinical trials.

NIAID’s Strategic Plan for the Development of a Universal Influenza Vaccine provides a research agenda for understanding and addressing scientific challenges to overcome suboptimal vaccine effectiveness and support activities focused on development of a universal influenza vaccine. Universal influenza vaccines would provide markedly improved breadth and durability of protection compared to currently licensed products. Emphasis is placed on development of a vaccine against IAV to address the combined seasonal and pandemic threats caused by IAV subtypes. However, there is significant interest in the development of vaccines that can provide broad, durable protection against both IAV and IBV strains, thus further optimizing preventive measures against seasonal influenza.

Research Objectives and Scope

The objective of this Funding Opportunity Announcement (FOA) is to support milestone-driven research projects focused on establishing proof-of-concept for and/or preclinical development of candidate universal influenza vaccines that protect against IBV or both IAV and IBV. Of particular interest are projects that include the development and/or characterization of IBV vaccine components that complement existing lead IAV vaccine candidates. It also is anticipated that this initiative will stimulate innovative, potentially high-risk approaches that support the discovery and early development of novel universal influenza vaccine candidates. The R21 phase of the award may include proof-of-concept studies and/or lead candidate optimization. For the purpose of this FOA, universal influenza vaccines are defined as providing improved breadth and/or durability of protection compared to licensed, quadrivalent seasonal influenza vaccines. “Candidate vaccine” is defined as a vaccine or related vaccine product and may include, but is not limited to, novel approaches in nucleic acid vaccination; new/improved replicating or non-replicating recombinant vectors; new/improved live attenuated vaccine virus; and/or nanoparticle design that demonstrate enhanced humoral and cell-mediated responses across multiple IAV and IBV strains. “Lead candidate” is defined as a candidate vaccine for which proof-of-concept data have been obtained and “preclinical development” is defined as all activities beyond lead candidate identification.

Examples of potential research efforts to be supported may include, but are not limited to:

  • Identification and testing of novel antigens based on emerging findings in influenza structural biology, immunology, or host responses that are predicted to improve protection against influenza A and B viruses.
  • Evaluation of vaccine candidates in functional in vitro assays.
  • Assessment of immunogenicity in relevant influenza animal models.
  • Completion of proof-of-concept efficacy studies in relevant animal models.
  • Head-to-head comparison of candidate vaccines.
  • Iterative optimization of lead vaccine candidate.
  • Optimization of dose and route of delivery in preclinical evaluation.

GrantWatch ID#:

GrantWatch ID#: 189171

Estimated Total Program Funding:

$3,000,000

Estimated Size of Grant:

Application budgets are limited to $275,000 in direct costs over the two-year project period for the R21 phase, with a maximum of $200,000 in direct costs allowed in any single year. The R33 award phase is limited to $300,000 in direct costs per year.

Term of Contract:

Earliest Start Date: March 2021

This FOA will use the R21/R33 Phased Innovation award mechanism. Support will be provided for two years for the R21 phase (for milestone-driven exploratory or feasibility studies) and up to three years of support may follow for the R33 phase (for expanded development).

Eligibility:

  • City or township governments
  • County governments
  • For profit organizations other than small businesses
  • Independent school districts
  • Indian housing authorities
  • Native American tribal governments (Federally recognized)
  • 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
  • Public and State controlled institutions of higher education
  • Public housing authorities
  • See RFP and/or Grant Guidelines for full eligibility
  • Small businesses
  • Special district governments
  • State governments

Additional Eligibility Criteria:

Higher Education Institutions

- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

- Small Businesses
- For-Profit Organizations (Other than Small Businesses)

Governments

- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession

Other

- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

- Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
- Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
- Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Eligible Individuals (Program Director/Principal Investigator):

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Note: Applications proposing the following will be considered non-responsive and will not be reviewed:

- Evaluation and/or development of vaccine candidates targeting only influenza A viruses.
- Evaluation and/or development of vaccine candidates that are strain specific.
- Projects that propose development of adjuvant technologies or vaccine delivery devices with the goal of increasing the breadth or duration of protection of commercially available seasonal influenza vaccines.
- Basic scientific/mechanistic studies without a clear objective of directly translating findings into above-specified vaccine candidate development.
- Projects proposing to develop monoclonal antibodies for post-exposure prophylaxis or the therapeutic treatment of influenza disease in infected patients, unless it can be demonstrated that administration leads to long term protection against influenza infection.

Not Allowed: Only accepting applications that do not propose clinical trials

Pre-Application Information:

Posted Date: February 27, 2020
Open Date (Earliest Submission Date): June 02, 2020
Letter of Intent Due Date(s): Not Applicable
Application Due Date(s): July 2, 2020
Scientific Merit Review: November 2020
Advisory Council Review: January 2021

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide (https://grants.nih.gov/grants/guide/url_redirect.htm?id=12000), except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts: https://grants.nih.gov/grants/guide/).

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

View this opportunity on Grants.gov: https://www.grants.gov/web/grants/view-opportunity.html?oppId=324904

For a list of application documents, see the Package tab (press Preview) on the Grants.gov page above.

Contact Information:

Before starting your grant application, please review the funding source's website listed below for updates/changes/addendums/conferences/LOIs.

Apply online using ASSIST: https://public.era.nih.gov/assist

eRA Commons login: https://public.era.nih.gov/commons/public/login.do?TARGET=https%3A%2F%2Fpublic.era.nih.gov%2Fcommons%2FcommonsInit.do

Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threatensubmission by the due date, and post-submission issues)
Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:support@grants.gov

Scientific/Research Contact(s)
Michael Schaefer, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3364
Email: mschaefer@niaid.nih.gov

Peer Review Contact(s)
Jian Wang, M.D, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-827-3396
Email: wangjian@csr.nih.gov

Financial/Grants Management Contact(s)
Jenna Briggs
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-5137
Email: jenna.briggs@nih.gov

CFDA Number:

93.855

Funding or Pin Number:

RFA-AI-20-003

URL for Full Text (RFP):

Geographic Focus:

USA: Alabama;   Alaska;   Arizona;   Arkansas;   California;   Colorado;   Connecticut;   Delaware;   Florida;   Georgia;   Hawaii;   Idaho;   Illinois;   Indiana;   Iowa;   Kansas;   Kentucky;   Louisiana;   Maine;   Maryland;   Massachusetts;   Michigan;   Minnesota;   Mississippi;   Missouri;   Montana;   Nebraska;   Nevada;   New Hampshire;   New Jersey;   New Mexico;   New York City;   New York;   North Carolina;   North Dakota;   Ohio;   Oklahoma;   Oregon;   Pennsylvania;   Rhode Island;   South Carolina;   South Dakota;   Tennessee;   Texas;   Utah;   Vermont;   Virginia;   Washington, DC;   Washington;   West Virginia;   Wisconsin;   Wyoming

USA Territories: American Samoa (USA)   Guam (USA)   Puerto Rico (USA)   Virgin Islands (USA)   Northern Mariana Islands (USA)

USA Compact Free Associations: The Federated States of Micronesia (USA)   Marshall Islands (USA)   Republic of Palau (USA)

Canada: Alberta;   British Columbia;   Manitoba;   New Brunswick;   Newfoundland and Labrador;   Northwest Territories;   Nova Scotia;   Nunavut;   Ontario;   Prince Edward Island;   Quebec;   Saskatchewan;   Yukon;

Israel

International country outside of the USA, Israel and Canada.

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