Key Dates

Related Announcements

• May 07, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed) See NOFO PA-20-195
• May 05, 2020- NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See PA-20-185 

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The objective of this Notice of Special Interest (NOSI) is to support research that contributes to the areas of interest outlined in NIAID’s Strategic Plan for the Development of a Universal Influenza Vaccine. The proposed research should have clear relevance to the research objectives defined in the strategic plan, which encompasses three major research areas:

• Improve understanding of transmission, natural history and pathogenesis of influenza virus infection.
• Characterize influenza immunity and correlates of immune protection.
• Support rational design of universal influenza vaccines.

Background

While vaccines remain the greatest public health tool to protect against influenza illness and disease, the effectiveness of seasonal influenza vaccine remains suboptimal, ranging between 10% and 60%. Circulating viral strains are difficult to predict and the co-circulation of antigenically drifted strains can potentially lead to vaccine mismatches, lowering overall vaccine effectiveness each season. In addition, viral strains with pandemic potential continue to spill over from avian to mammalian species, further underscoring the on-going global threat of influenza to public health. To limit the public health consequences of both seasonal and pandemic influenza, vaccines with broader, more durable protection are needed. NIAID continues to identify efforts for the full implementation of the 2018 Strategic Plan for the Development of a Universal Influenza Vaccine. Important progress continues to be made; however scientific gaps remain that are critical to achieving broad, durable protection against influenza infection and disease.

Research Objectives

The purpose of this NOSI is to continue to foster new and innovative scientific endeavors in all areas defined in the Strategic Plan for the Development of a Universal Influenza Vaccine. Specific areas of research interest include, but are not limited to:

• Expand understanding of how viral, host, and environmental factors contribute to viral transmission.
• Define the role of anti-hemagglutinin (HA) stem and anti-neuraminidase (NA) antibodies in prevention of transmission.
• Identify factors associated with the severity of influenza.
• Precisely characterize circulating influenza viruses to assess the breadth of protection required from vaccines.
• Improve understanding of antigenic drift and immunodominance of various influenza antigens.
• Investigate interrelated roles of T and B cells in influenza responses to vaccination and infection.
• Characterize immune responses in diverse populations (including but not limited to different ages, sex, pregnancy, obesity, presence of coinfections or other comorbidities, and compromised immunity).
• Identify factors that determine immunodominant hierarchies of B cell responses.
• Characterize antibody responses to HA and NA and their contribution to immune protection.
• Define how the initial encounter with an influenza virus (i.e., immune imprinting) affects B and T cell responses, including immunologic responses to subsequent influenza virus infection.
• Identify major influenza epitopes that elicit broadly protective T cell immunity.
• Determine T cell effector function(s) necessary to enhance protective immunity or to modulate disease severity.
• Determine whether T cells require localization in lymph nodes or mucosal tissue to be protective.
• Rational design of new immunogens, and mechanistic characterization of vaccines with greater breadth and durability than currently licensed vaccines.
• Utilize new vaccine approaches that elicit both humoral and cell-mediated responses.
• Employ novel delivery mechanisms or vaccine regimens that result in improved mucosal or tissue resident responses.
• Incorporate novel adjuvants, with a specific emphasis on combination adjuvants and mucosal adjuvants, to enhance vaccine responses.
• Test controlled-release vaccine strategies to improve the breadth and durability of vaccine responses.
• Develop animal models to test T-cell targeting vaccine platforms.
• Compare data from human challenge studies with data from studies of natural infection.
• Utilize existing datasets from human cohorts and animal models to better predict protective responses to infection and/or vaccination. 

Application and Submission Information

This notice applies to application receipt dates on or after February 5, 2025 and subsequent receipt dates through November 16, 2027.

Submit applications for this initiative using one of the following notices of funding opportunities (NOFOs) or any reissues of these announcements through the expiration date of this notice.

• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the NOFO used for submission must be followed, with the following additions:

For funding consideration, applicants must include “NOT-AI-24-081” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:

Scientific/Research Contact(s)

Jennifer L. Gordon, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Division of Microbiology and Infectious Diseases
Telephone: 301-761-6805
Email: [email protected]

Kentner Singleton, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Division of Allergy, Immunology, and Transplantation
Telephone: 240-669-5499
Email: [email protected]

Financial/Grants Management Contact(s)

Vandhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
Email: [email protected]