NIAID and NIGMS are issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on the 2019 novel Coronavirus (2019-nCoV). NIAID is particularly interested in projects focusing on viral natural history, pathogenicity, transmission, as well as projects developing medical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeutics against 2019-nCoV.

NIGMS is specifically interested in incorporation of data from the 2019-nCoV into ongoing research efforts to develop predictive models for the spread of Coronaviruses and related pathogens.

NIAID and NIGMS are therefore offering Competitive Revisions to active grants addressing research objectives described below.

Background

Coronaviruses are a diverse family of viruses that cause a range of disease in humans and animals, and there are currently no approved coronavirus vaccines or therapeutics. In January 2020, a novel coronavirus, 2019-nCoV, was identified as the causative agent of an outbreak of viral pneumonia centered around Wuhan, China. Current information regarding confirmed cases is changing daily and can be found on the Centers for Disease Control and Prevention website (https://www.cdc.gov/coronavirus/index.html) and through other sources. Transmission characteristics and the associated morbidity and mortality are not completely understood, but there is clear evidence of human-to-human transmission. Many other aspects of viral pathogenesis, natural history, and host range are poorly understood. Given this, there is an urgent public health need to better understand the 2019-nCoV, particularly to improve understanding of fundamental virology, immunology, and the development of animal models and medical countermeasures.

Research Objectives

In order to rapidly improve our understanding and available control measures for 2019-nCoV, NIAID is encouraging the submission of applications for Competitive Revisions to active grants to address the following research areas of interest:

• Studies to identify optimal 2019-nCoV in vitro culture requirements and conditions;
• Development of reagents and assays for virus characterization;
• Studies to understand critical aspects of viral infection, replication, pathogenesis, and transmission;
• Studies to identify viral epitopes critical for binding neutralization;
• Studies to examine virus stability and persistence;
• Production of molecular clones of 2019-nCoV, reporter viruses and recombinant viral proteins;
• Development of animal models of 2019-nCoV infection suitable for screening vaccine and therapeutic candidates and/or pathogenesis studies;
• Studies on the evolution and emergence of 2019-nCoV viruses including the identification of factors that affect viral host-range and virulence;
• Virologic and serologic surveillance studies of the distribution and natural history of 2019-nCoV viruses in animal populations and in humans at the human/animal interface with particular emphasis on host reservoirs and understanding cross-species transmission events;
• Development of sensitive, specific, and rapid clinical diagnostic tests for 2019-nCoV;
• Development of 2019-nCoV therapeutic candidates; broad-spectrum therapeutics against multiple coronavirus strains; examination of 2019-nCoV antiviral activity of existing or candidate therapeutics initially developed for other indications;
• Identification and evaluation of the innate, cellular and humoral immune responses to 2019-nCoV infection and/or candidate vaccines, including, but not limited to: cross-reactive antibodies from individuals exposed to 2019-nCoV and other coronaviruses; viral epitopes critical for antibody binding and neutralization; immune-mediated pathology or host factors that might predispose to severe infection; and
• Development of 2019-nCoV vaccine candidates that include emerging antigen design strategies, novel platforms or delivery approaches, adjuvants, or assessing cross-neutralization potential of SARS-CoV vaccine candidates.

NIGMS Interests

• Incorporation of data related to the 2019-nCoV into ongoing research efforts to develop predictive models for the spread of coronaviruses and related infectious agents.

Application and Submission Information

Applications in response to this NOSI must be submitted using the following targeted funding opportunity:

• PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional), which is intended to provide funds for NIH grantees applying to expand the scope of their active grant. Further details can be found here: https://www.niaid.nih.gov/grants-contracts/urgent-award-mechanism..
• The funding instrument, or activity code, will be the same as the parent award.
• Please note:NOT-AI-20-030 is specific for PA-18-935. NIH grantees seeking additional funds for research responsive to the 2019-nCoV outbreak that falls within the scope of an ongoing grant should instead apply for an administrative supplement under NIH PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements FOA (https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html).
  

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide and PA-18-935 must be followed, with the following additions:

• The Research Strategy section of the application is limited to 6 pages.
• The award project period of the Competitive Revision must not exceed two years.
• Application budgets are limited to no more than the amount of the current parent award, and must reflect the actual needs of the proposed project.
• The parent award must be active when the application is submitted. The project and budget periods must be within the currently approved project period for the existing parent award.
• Applications will be accepted on a rolling basis from February 6, 2020 through April 8, 2020 by 5:00 PM local time of the applicant organization. This NOSI expires on April 8, 2020. An application submitted in response to this NOSI that is received on April 8, 2020 or later, will be withdrawn.
• Applications must be submitted to PA-18-935, Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement Clinical Trial Optional)" and must use the application form package with the Competition ID of NOT-AI-20-030-FORMS-E"
• IMPORTANT: For funding consideration, all applicants must designate NOT-AI-20-030 (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.
• Investigators planning to submit an application in response to the NOSI are strongly encouraged to contact the program officers listed below to discuss the proposed project in the context of the parent award.

Although NIGMS is not listed as a Participating Organization in all the FOAs listed above, applications for this initiative will be accepted.

Scientific/Research Contact(s)

Erik J. Stemmy, Ph.D.
Respiratory Diseases Branch
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3380
Email: [email protected]

Wolfgang Leitner, Ph.D.
Basic Immunology Branch
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3575
Email: [email protected]

Daniel E. Janes, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Financial/Grants Management Contact(s)

Donna R. Sullivan
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2979
Email: [email protected]

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