Request for Information (RFI): Inviting Comments and Suggestions to Advance Research and Vaccine Development for Coccidioidomycosis (Valley Fever)
Notice Number:
NOT-AI-22-026

Key Dates

Release Date:

February 2, 2022

Response Date:
April 05, 2022

Related Announcements

None

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

This Notice is a Request for Information (RFI) inviting comments and suggestions on NIAID’s key strategic approaches to advance research on, and vaccine development for, coccidioidomycosis (Valley Fever).

Note: Review of this entire RFI notice is encouraged to ensure a comprehensive response is prepared and to have a full understanding of how your response will be utilized.

Background

NIAID is developing a Strategic Plan for Research to Develop a Coccidioidomycosis Vaccine. The strategic plan will be structured around three areas of research vital to developing a vaccine for coccidioidomycosis.

Strategic Priority 1: Understand Coccidioides pathogenesis and host response

  • Improve understanding of pathogenesis
  • Expand understanding of the pathogen life cycle, including the role of host factors, physical and environmental factors that contribute to disease
  • Determine the interaction of innate and adaptive immunity in response to infection
  • Identify immune markers associated with reduced disease severity
  • Improve genotypic and phenotypic characterization associated with adverse clinical outcomes, and host immunity
  • Elucidate mechanisms of protective immunity vs. those that ameliorate symptomatic disease
  • Identify immunogens that elicit broad protection
  • Determine impact of individual species on clinical outcomes
  • Identify biomarkers that could inform disease progression and contribute to rapid diagnostics
  • Define mechanisms and correlates of natural infection-induced protection
  • Define mechanisms and correlates of vaccine-induced protection

Strategic Priority 2: Develop vaccine strategies to prevent coccidiomycosis

  • Advance new vaccine approaches into preclinical models that exploit emerging antigen design strategies, novel technologies, and/or platforms
  • Support rational design of vaccines for coccidioidomycosis
  • Test adjuvants and alternative delivery methods to enhance breadth and durability of immunity
  • Understand the impact/safety of vaccination in previously infected individual

Strategic Priority 3: Develop Tools and Resources

  • Develop rapid, point of care diagnostics
  • Develop cell culture and animal models that reflect human disease for preclinical use
  • Promote cross-disciplinary research and support early investigators to expand the cadre of innovative cocci researchers
  • Leverage and expand clinical capacity to test vaccine candidates, particularly for high-risk and underserved populations
  • Encourage collaborations between researchers and vaccine developers

Information Requested

This RFI seeks input from stakeholders throughout the scientific research community and the general public regarding the above proposed framework.

NIH seeks comments on any or all of, but not limited to, the following topics in Coccidioides research:

  • Significant research gaps and/or barriers not identified in the strategic priorities above
  • Identification of items most likely to facilitate vaccine development
  • Necessary resources critical to advancing research in the three strategic areas
  • Emerging scientific advances or techniques that may accelerate research related to the three priorities
  • Approaches to increase marketability of a vaccine and facilitate collaborations with industry

How to Submit a Response

All comments must be submitted electronically on the submission website.

NIH encourages organizations (e.g., patient advocacy groups, professional organizations) to submit a single response reflective of the views of the organization or membership as a whole.

Responses (no longer than 500 words in MS Word or pdf format) must be received by 11:59:59 pm (ET) on April 5, 2022. You will see an electronic confirmation acknowledging receipt of your response.

Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

We look forward to your input and hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to: