Slots: 1
Deadlines
Internal Deadline: Contact RII.
LOI: 30 days prior.
External Deadline: June 9, 2023
Award Information
Award Type: Cooperative Agreement
Estimated Number of Awards: NIAID intends to commit a total of $12.1 million in FY 2024 to support all the activities of the Consortium for Food Allergy Research. This $12.1 million includes funding for: 1) one award for the CoFAR Leadership Center for an estimated $7.3 million, and 2) through the companion FOA, the support for 12 awards for CoFAR CRCs.
Anticipated Award Amount: Application budgets should reflect the actual needs of the project. These include funding for 1) the CoFAR-LC functions, 2) The CoFAR network-wide clinical research projects including protocol-specific funds for CoFAR-CRCs and for the mechanistic studies incorporated in these projects, 3) 2 years of support to complete CoFAR-11.
Who May Serve as PI: Standard NIH requirements.
Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-22-077.html
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure (RII) Application Portal: https://rii.usc.edu/oor-portal/. Use the template provided here:
RII-Limited-Submission-Application-Template.
Materials to submit include:
- (1) Two-Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.
Purpose
CoFAR is a clinical network consisting of two distinct entities, the CoFAR Leadership Center (LC) and the CoFAR Clinical Research Centers (CRCs). The two entities will work collaboratively to conduct network-wide, ground-breaking clinical research projects in the areas of prevention, therapy, and understanding of the mechanisms of food allergy. The CoFAR-LC will provide leadership, overall strategy, and support for the network-wide clinical research projects. The CoFAR-CRCs will execute all network-wide clinical research projects.
It is expected that CoFAR will conduct at least two network-wide clinical research projects. At least one of these projects will be a therapeutic or preventive clinical trial. Both the CoFAR-LC and the CoFAR-CRCs will propose network-wide clinical research projects. Once CoFAR is formed, these proposals will be considered by the CoFAR Steering Committee and those to be executed will be chosen by the CoFAR-LC PD(s)/PI(s). The network-wide clinical research projects that the CoFAR will conduct will require approval by NIAID, which will consider programmatic priorities in its decision.
In addition to providing leadership, scientific strategy and organizational structure for the network, the CoFAR-LC will be responsible for distributing protocol funds to the CoFAR-CRCs to execute the network-wide CoFAR clinical research projects. Furthermore, the CoFAR-LC is expected to propose mechanistic research using clinical samples provided by the CRCs as part of the CoFAR clinical research projects to accelerate the translation of basic research advances into clinical applications. All research developed by the CoFAR-LC will involve human subjects.
The CoFAR-LC will propose two clinical research projects. The scope of these projects includes but is not limited to therapeutic or preventive clinical trials focusing on innovative approaches, observational human studies to improve the epidemiology and better understand the pathophysiology of food allergy conditions, and studies to improve food allergy diagnosis. Phase 3 trials are acceptable but will require strong justification and demonstration of feasibility. Focus areas might include:
- Therapeutic or preventive trials of
- Early allergenic food introduction for the prevention of IgE-mediated food allergy
- Direct or indirect manipulation of the microbiome
- Food allergen immunotherapy
- Drugs, biologics, adjuvants, or devices for the management of food allergy conditions
- Combinations of the above
- Studies to improve the diagnosis of food allergy aiming at replacing oral food challenges
- Studies to accurately assess the incidence and prevalence of food allergy conditions in diverse populations, in the US
- Studies examining the interactions between immunologic, microbial, environmental, and genetic or epigenetic factors underlying the development of food allergy conditions
- Studies of molecular mechanisms associated with the development and clinical presentation of food allergy conditions or response to therapy (targeted and/or unbiased approaches)
- Studies on the mechanisms underlying severe allergic reactions
Applicants may submit to both the CoFAR Leadership Center and the CoFAR Clinical Research Centers (RFA-AI-22-076). However, the two network-wide clinical research projects proposed in the CoFAR-LC application must be different than the network-wide clinical trials or studies proposed in the CoFAR-CRC application.
The CoFAR-LC will be responsible for ensuring completion of two ongoing CoFAR studies:
CoFAR-11: Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (https://clinicaltrials.gov/ct2/show/NCT03881696). It is anticipated that the trial will be completely enrolled by the end of the current grant and that the last patient last visit will occur by March of 2026.
CoFAR-12: Systems Biology of Early Atopy (https://clinicaltrials.gov/ct2/show/NCT04798079). This observational study is anticipated to complete recruitment in July 2023 and will continue through at least July 2026.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.