NIAID is interested in supporting vaccine research and development against enteric viruses through a Notice of Special Interest (NOSI): Promoting Research and Development of Vaccines Against Enteric Viruses. The scope of supported research extends to three major topic areas: 1) address gaps in enteric virus research to support vaccine development; 2) develop tools and resources to support vaccine development; and 3) develop and advance new vaccine candidates to prevent infection or severe gastrointestinal (GI) disease. NIAID encourages studies focusing on rotavirus (RV), caliciviruses, astroviruses, and adenoviruses (Human mastadenovirus F and G).

Research Objectives

This NOSI aims to address this research gap and promote new vaccine research to advance development of vaccine candidates against enteric viruses that cause gastroenteritis in infants and young children, immune-compromised and -suppressed people, and elderly people. Additionally, there is a need for next generation RV vaccines with greater effectiveness in the developing world and there are no licensed childhood vaccines against human adenovirus (HAdV), human norovirus (HuNoV), human astrovirus (HAstV), and human sapovirus (HuSaV). We also encourage the research community to develop candidates for late-stage clinical trial evaluation.

NIAID-specific areas of research interest include but are not limited to the following:

• Address gaps in enteric virus research to support the development of a vaccine.
  • Disease burden studies across all ages or in immunosuppressed patients.
  • Improve understanding of basic virology of understudied viruses such as HAdV, HAstV, and HuSaV.
  • Cross-protective immunity studies.
  • Characterize factors that aid virus survival and immune evasion.
  • Immune landscape studies to identify and characterize antibodies following natural infection or vaccination.
  • Structural biology research to define the atomic-level details of surface proteins likely to be immunologic targets.
  • Research developing new platforms and approaches such as mRNA vaccines or combination vaccines.
• Develop tools and resources to support vaccine research.
  • Develop genetic tools and molecular resources such as reverse genetic systems to delineate virus biology and develop multivalent vaccines.
  • Develop 3D cell culture and animal models for proof-of-concept studies.
  • Develop assays to identify and characterize immune correlates of protection.
• Develop and advance vaccines to prevent gastroenteritis.
  • Support and advance vaccines into preclinical models that exploit emerging antigen design strategies, novel technologies, and/or platforms.
  • Candidate development either as combination or stand-alone vaccines.
  • Test adjuvants and alternative delivery methods to enhance breadth and durability of immunity.
  • Test vaccine candidates in diverse populations, especially in infants and children in low- and middle-income countries.

Applications and Submission Information

This notice applies to application receipt dates on or after September 5, 2023, and subsequent receipt dates through July 16, 2026.

Apply to this initiative using one of the following notices of funding opportunities (NOFOs) or any reissues of these opportunities through the expiration date of this notice.

• PA-20-185 – NIH Research Project Grant (Parent R01, Clinical Trial Not Allowed)
• PA-20-183 – Research Project Grant (Parent R01, Clinical Trial Required)
• PA-20-195 – NIH Exploratory/Developmental Research Grant Program (Parent R21, Clinical Trial Not Allowed)
• PA-20-194 – NIH Exploratory/Developmental Research Grant Program (Parent R21, Clinical Trial Required)
• PA-22-178 – PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent R41/R42, Clinical Trial Not Allowed)
• PA-22-176 – PHS 2022-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent R43/R44, Clinical Trial Not Allowed)
• PAR-21-082 – NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required)

You should follow all instructions in the SF 424 (R&R) Application Guide and the NOFO, with the following additions:

• For funding consideration, applicants must include “NOT-AI-23-048” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF 424 R&R form. NIAID will not consider applications that do not have this information in box 4B.

NIAID will consider applications outside of the terms of this NOSI to be nonresponsive.

Contact Information

Direct any inquiries about this NOSI to NIAID’s scientific/research contact, Dr. Rodolfo Alarcon at Rodolfo.alarcon@nih.gov or 240-292-0871.