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Issued by

National Cancer Institute (NCI)

Purpose

This Notice is a time-sensitive Request for Information (RFI) inviting comments and suggestions on the topic of research approaches and priorities related to SARS-CoV-2 serology.

On April 23, 2020, in response to the SARS-CoV-2 pandemic, Congress approved the Paycheck Protection Program and Health Care Enhancement Act, providing $306M to the National Cancer Institute (NCI), working with the National Institute of Allergy and Infectious Disease (NIAID) and other parts of the NIH “to develop, validate, improve, and implement serological testing and associated technologies.” As a result of this Congressional mandate, the NCI and NIAID are soliciting community input via this RFI on the topic of research priorities for serological research and related technologies to address the immense public health and economic burdens created by COVID-19.

NIAID has recently published a Strategic Plan for COVID-19 Research. This RFI is specifically related to the identification and delineation of national research priorities for serologic research and related technologies, as highlighted in the NIAID Strategic Plan:

• Priority 1.1 Characterize the fundamental virologic and immunologic response
• Priority 1.2 Evaluate disease dynamics through natural history and surveillance studies
• Priority 2 Support the development of diagnostics and assays

Other COVID-19 research priorities are being targeted by additional efforts throughout the NIH and other governmental agencies.

Background

Serologic testing is a critical component of infectious disease research and epidemiology. High-performance assays of humoral immune response, which can be done reliably and at large scale with low cost, can provide key information related to an individual’s prior infection and may have implications for future disease resistance. As such, robust serologic testing, particularly as part of seroprevalence surveys, is key to understanding population-wide viral pathogenicity, developing and testing SARS-CoV-2 vaccines, and understanding antibody production and immunity. The relationship between prior infection, antibody production, and future immunity is not well established for SARS-CoV-2, and the identification of approaches to address these topics is a major goal of this RFI.

The NCI seeks comments on any or all of, but not limited to, the following research topics related to serology:

1. Research about the relationship between immunity, recent infection, antibody production, and other immunological markers, including:
   • The role and value of animal models and in vitro assays for determining the relationship between antibody production and immunity to SARS-CoV-2.
   • The types and titers of antibodies that are important for immune protection and the mechanism of such protection.
   • Whether cross-reacting antibodies from prior infection by other coronaviruses confer immunity.
   • Whether antibodies to coronaviridae can cause immunopathogenesis (e.g. ADE).
   • Genetic or other host factors that could predict antibody production and innate or adaptive immunity.
   • Specific virologic factors that mediate the generation of effective host immunity, especially humoral immunity vs. cell-mediated immunity.
2. Clinical utilization of serological testing, including:
   • Design strategies for use in clinical trials and population-based observational studies that are optimal to address the most critical research questions, including biospecimen sampling/biobanking considerations as well as safety and ethical considerations.
   • Characteristics and performance standards needed for serological testing, whether for seroprevalence surveys or point-of-care tests.
   • Approaches to rapidly increase capacity for high-quality serology testing in United States, by leveraging existing infrastructure, especially for underserved communities.
   • How to use and interpret serological testing results safely, effectively, and equitably.

NCI is also specifically interested in the link to cancer across all of these areas, including but not limited to the characteristics of the immune response in patients undergoing treatment and cancer survivors; prediction of susceptibility to infection and outcomes in cancer patients; seroepidemiology in cancer patients.

NCI seeks input on any of the research topics above or other topics relevant to research in coronavirus serology testing. Your comments could include any of the following: research approaches for these topics; innovative strategies to advance research progress; the challenges to progress in these areas; emerging trends, advances, technologies, analytic strategies, and perspectives that NCI should consider in this planning process; potential approaches to gauge research progress and success. Please comment on any other topic that you find relevant.

How to Submit a Response

Responses to this RFI must be submitted electronically via email to [email protected]

Responses must be received by 11:59 pm (ET) on May 26, 2020. Please indicate “RFI Response” in the subject line of the email and include a reference to NOT-CA-20-065. You will see an electronic confirmation acknowledging receipt of your response. However, responders will not receive individualized feedback from NCI. A responder need not address all the topics presented in this document and may comment on as few as one topic.

Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. 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 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 informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.

Applications are not being solicited at this time.

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

Inquiries

Please direct all inquiries to:

[email protected].