Key Dates

Related Announcements

• May 5, 2020 – Research Project Grant (Parent R01 Clinical Trial Required). See NOFO PA-20-183
• May 5, 2020 – NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185
• May 7, 2020 – NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required). See NOFO PA-20-194
• May 7, 2020 – NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed). See NOFO PA-20-195
• January 14, 2021 – NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required. See NOFO PAR-21-082
• June 2, 2022 – PHS 2022-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed). See NOFO PA-22-176
• June 2, 2022 – PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed). See NOFO PA-22-178

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to highlight NIAID’s interest in supporting vaccine research and development against enteric viruses.  The scope of research supported is in three major topic areas: 1) address gaps in enteric virus research to support the development of a vaccine; 2) develop tools and resources to support vaccine development; and 3) develop and advance new vaccine candidates to prevent infection or severe gastrointestinal disease. This NOSI encourages studies focusing on  rotavirus, caliciviruses, astroviruses, and adenoviruses (Human mastadenovirus F and G).

Background

Pathogenic enteric viruses that cause gastroenteritis are major causes of worldwide morbidity and mortality, particularly in the elderly, immuno-compromised and -suppressed, and children from low-income countries under the age of five. Enteric viruses such as adenovirus-F and -G (Adenoviridae), norovirus and sapovirus (Caliciviridae), astrovirus (Astroviridae), and rotavirus (Reoviridae) are spread by fecal-oral transmission resulting in localized intestinal infections characterized by tissue inflammation, disruption of the epithelial barrier, malabsorption, diarrhea, and vomiting.

Rotaviruses (RVs) are the major cause of life-threatening diarrheal disease in infants and young children worldwide, causing over 200,000 deaths and millions of hospitalizations each year. Human adenovirus (HAdV) and norovirus (HuNoV) are estimated to cause an added 100,000 annual deaths. Mortality estimates for human astrovirus (HAstV) and sapovirus (HuSaV) are not clear, but they are increasingly being recognized in diarrheal disease outbreaks in countries with national RV vaccination programs. Two childhood live attenuated oral RV vaccines were licensed in 2006 and are highly effective in developed nations, though their efficacies are 35-40% less in developing countries where most RV morbidity and mortality remain. There is a need for next generation RV vaccines with greater effectiveness in the developing world and there are no currently licensed childhood vaccines against HAdV, HuNoV, HAstV, and HuSaV.

In adults, HuNoV is the principal cause of global acute gastroenteritis outbreaks. It is also documented as a leading viral cause of chronic diarrheal disease in solid organ and stem cell transplant patients. There are no effective antivirals targeting any of these select enteric viruses and treatment of viral gastroenteritis is primarily with rehydration solutions. These gaps highlight the need for vaccines to prevent infections from RV, HAdV, HuNoV, HAstV, and HuSaV, which together account for most acute and chronic infections in people of all ages. 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, immuno-compromised and -suppressed, and/or elderly people. Vaccines can target single or multiple viruses, such as combination vaccines with the ability to protect against several viruses or that can protect against several strains of a single pathogen. Novel approaches such as mRNA, nanoparticle, and structure-based design are encouraged.

Research Objectives

This NOSI is designed to encourage the research community to develop a range of approaches for vaccine research and development using both established and novel technologies with the long-term goal of developing candidates for late-stage clinical trial evaluation. This NOSI promotes new research in three major topic areas: 1) address gaps in enteric virus research to support the development of a vaccine; 2) develop tools and resources to support vaccine development; and 3) develop and advance new vaccine candidates to prevent infection or severe gastrointestinal disease.

Areas of interest include but are not limited to:

• Address gaps in enteric virus research to support the development of a vaccine
  
  
  • Disease burden studies across all ages and/or in immunosuppressed patients
  • Improve understanding of basic virology of understudied viruses such 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 
     

Application and Submission Information

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

Submit applications for 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 STTR [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 SBIR [R43/R44] Clinical Trial Not Allowed)
• PAR-21-082 – NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required

All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity used for submission must be followed, 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 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)

Rodolfo M. Alarc n, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-0871
Email: [email protected]

Financial/Grants Management Contact(s)

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