Key Dates

Related Announcements

NOT-AI-23-030 - Notice of Early Expiration of Notice of Special Interest (NOSI): Advancing Research Needed to Develop a Coccidioidomycosis (Valley fever) Vaccine" NOT-AI-23-007

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-22-179 PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
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)
PA-22-177 PHS 2022-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

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 research in the areas outlined in the NIAID Strategic Plan For Research To Develop A Valley Fever Vaccine. The proposed research should have clear relevance to the strategic priorities defined in the strategic plan, which encompasses three major research areas: 1) address gaps in Coccidioides basic research to support the development of a vaccine; 2) develop tools and resources to support vaccine development; 3) develop and advance vaccines to prevent coccidioidomycosis.

Background

Coccidioidomycosis, more commonly known as Valley fever, is a fungal infection of increasing public health concern in the United States. Clinical manifestations range from mild flu-like disease to severe disseminated infection that can require life-long therapy. Valley fever is most common to the arid regions of the southwestern United States, Mexico and Central and South America. In 2019, more than 20,000 cases were reported to the Centers for Disease Control and Prevention (CDC), and this is likely an underestimate as many patients go undiagnosed or misdiagnosed due to delays in testing. Over the past decade, the prevalence and geographic spread of Valley fever has steadily increased, contributing to the urgency to develop better medical countermeasures for this disease.

Currently, no vaccine is licensed to prevent Valley fever. Because Coccidioides infection in people usually provides protective immunity from reinfection, developing a safe and effective vaccine is generally thought to be feasible and would be expected to provide durable immunity. A safe and effective vaccine against Coccidioides infection could protect residents in the affected areas in the United States and other countries.

Research Objectives

This NOSI aims to stimulate research in the areas outlined in the NIAID Strategic Plan For Research To Develop A Valley Fever Vaccine. Areas of interest include but are not limited to:

• Address gaps in Coccidioides basic research to support the development of a vaccine
  • Develop genetic tools and molecular resources to delineate Coccidioides biology
  • Improve understanding of Coccidioides biology and life cycle in the host
  • Characterize host responses, including innate and adaptive immunity
  • Characterize virulence factors that aid Coccidioides survival and immune evasion
    
• Develop tools and resources to support Coccidioides vaccine research
  • Advance development of biomarkers that reflect disease progression
  • Develop rapid point-of-care diagnostics
  • Develop cell culture and animal models that reflect human disease
  • Leverage and expand clinical capacity to promote collaboration
    
• Develop and advance vaccines to prevent coccidioidomycosis
  • Support and advance vaccines into preclinical models that exploit emerging antigen design strategies, novel technologies, and/or platforms
  • Define mechanisms and correlates of vaccine-induced protection
  • Test adjuvants and alternative delivery methods to enhance breadth and durability of immunity
  • Test vaccine candidates in diverse populations

Application and Submission Information

This notice applies to application receipt dates on or after February 5, 2023, and subsequent receipt dates through January 7, 2026.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) 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-20-183 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-22-179 PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
• 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)
• PA-22-177 PHS 2022-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

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

• For funding consideration, applicants must include NOT-AI-23-007 (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

Scientific/Research Contact(s)

Dona C. Love, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7788
Email: Dona.Love@nih.gov

Financial/Grants Management Contact(s)

Vandhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-9824
Email: vandhana.khurana@nih.gov