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PAR-20-072 - NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

NIAID is issuing this Notice of Special Interest (NOSI) to highlight the critical need to develop prophylactic vaccines able to provide broad and durable protection against coronaviruses (CoVs), especially SARS-CoV-2 and others with pandemic potential. NIAID is particularly interested in highly collaborative, multi-disciplinary Program Projects (P01s) that incorporate understanding of CoV virology and immunology, immunogen design, and innovative vaccine and adjuvant platforms and technologies to discover, design, and develop pan-coronavirus (pan-CoV) vaccine candidates that provide broad protective immunity to multiple CoV strains.

Background

CoVs are a diverse family of viruses that cause a range of disease in humans and animals for which there are no currently FDA-approved vaccines. Historical outbreaks of CoVs, including the Severe Acute Respiratory Syndrome CoV (SARS-CoV and the Middle East Respiratory Syndrome (MERS-CoV), coupled with the recent emergence of Severe Acute Respiratory Syndrome CoV-2 (SARS-CoV-2) and global Coronavirus Disease (COVID-19) pandemic highlight the urgent critical need to develop vaccines capable of broad protection against CoVs.

Research Objectives

To advance pan-CoV vaccine development, this program will support research to design and develop vaccine approaches intended to provide durable immunity against CoVs with an emphasis on CoVs with pandemic potential. Programs should be composed of research projects that:

• Address CoV diversity and infectious potential in humans as it relates to vaccine design challenges;
• Include innovative immunogen design and vaccine platforms/approaches to elicit potent and durable pan-CoV immunity;
• Evaluate CoV vaccine candidates in preclinical models, incorporating detailed immunologic assessments in blood and tissues.

Applications should also contain an administrative core and any scientific cores necessary for the proposed research. Projects should be designed to be flexible to incorporate newly emerging understanding of immune responses to SARS-CoV-2 infection and vaccination.

In order to rapidly advance pan-CoV vaccine development, NIAID encourages highly integrated, multi-disciplinary teams working collaboratively to develop research projects including, but not limited to, the following areas of interest:

• Identification of broadly reactive B- and T-cell epitopes;
• Structural studies of CoV proteins related to designing novel, effective immunogens;
• Rational design of CoV immunogens to elicit broadly neutralizing, durable antibodies against multiple CoVs;
• Studies to understand the role of antigen-specific T cell responses in immunity to CoVs, including strategies to induce T-cell immunity;
• Studies to identify correlates of protection against CoVs following natural infection or vaccination;
• Studies to understand vaccine induced responses across the life span, including investigation of age- or sex-related effects on vaccine efficacy;
• Studies to understand the impact of previous exposure to CoVs on subsequent vaccine responses;
• Studies to identify antigen/adjuvant combinations to induce potent and broad protection against multiple CoVs;
• Development of multi-valent and next generation vaccine platforms/strategies to provide durable immunity to multiple CoVs, and that are suitable for use in vulnerable populations;
• Iterative studies and head-to-head comparisonsof candidate vaccines in relevant preclinical models are encouraged to advance the most promising vaccine candidates;
• Strategies to direct protective immune responses to relevant tissues, such as mucosal sites.

Applications proposing basic studies of COVID-19 immunology without targeted vaccine design and evaluation of vaccine candidates in preclinical models are not responsive to this NOSI.

Investigators interested in responding to this NOSI are strongly encouraged to consult with NIAID staff at least 10 weeks prior to the application due date for submission of any NIAID Program Project (P01) application, including new, renewal and resubmission applications so that NIAID staff can consider whether the proposed program project meets the goals and mission of the Institute, and whether it addresses one or more high priority research areas. NIAID staff will not evaluate the technical and scientific merit of the proposed application/Program; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA. Furthermore, as a reminder, applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a scientific/research contact listed belowat least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. Applications submitted with direct costs of $500,000 or more in any year without prior approval will be returned to applicants without review.

Application and Submission Information

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

• PAR-20-072; NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed)

Applications will be received on two receipt dates: January 11, 2021 and June 11, 2021.

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide and PAR-20-072 must be followed, with the following additions:

• IMPORTANT: For funding consideration, all applicants must designate NOT-AI-21-002 (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.

Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award.

Funds awarded using appropriations provided by the The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 and The Coronavirus Aid, Relief, and Economic Security (CARES) Act will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Erik Stemmy, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3380
NIAIDCOVID19P01@niaid.nih.gov