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Consortium of Food Allergy Research Clinical Research Center at Cincinnati Children's Hospital Medical Center (CoFAR-CRC:CCHMC)

Award Number: U01AI181966
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/01/2024
PERIOD OF PERFORMANCE END DATE: 02/28/2031

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Consortium of Food Allergy Research Clinical Research Center at Cincinnati Children's Hospital Medical Center (CoFAR-CRC:CCHMC) - PROJECT SUMMARY The proposed Consortium of Food Allergy Research Clinical Research Center: Cincinnati Children's Hospital Medical Center (CoFAR-CRC:CCHMC) aims to bring the experience, expertise, and scientific productivity and the diverse patient populations of CCHMC to CoFAR. The patient population seen in the clinics and participating in the research of the Division of Allergy and Immunology at CCHMC encompass varied presentations and classifications of food allergy, including IgE-mediated food allergy (IgE-FA), eosinophilic esophagitis (EoE), and food protein–induced enterocolitis (FPIES). The CoFAR CRC:CCHMC approach to research is multipronged and self-sustaining by attracting patients with excellent care and creating and maintaining databases and registries supported by biospecimen collection and biobanking. Those are utilized in conducting mechanistic research that forms the basis of discoveries and clinical trials and advances knowledge that improves patient care and attracts more patients. The description of the CoFAR CRC:CCHMC will provide a) data on the capacity and readiness of the CRC; b) solid structure and wide range of services available; c) recruitment abilities from the CRC databases and the community, specifically of difficult-to-recruit populations, including minorities, infants, and adults; d) track record of initiation and successful and regulatory- compliant execution of collaborative, multi-center clinical trials; e) support of professional development of faculty and staff; and f) development and inclusion of junior faculty. We propose a network-wide, multicenter clinical trial focused on maintaining acquired tolerance to food allergens and a center-specific research project focused on defining the mechanism by which environmental factors contribute to the pathogenesis of food allergies. For our potential network-wide clinical trial, we hypothesize that the gradual lengthening of the dosing intervals in oral immunotherapy (OIT) in a similar pattern as in allergen immunotherapy protocols or cluster dosing (4 days consecutive dosing + 3-day dosing holiday weekly) will maintain OIT-acquired tolerance as well as daily dosing while providing a more manageable and acceptable dosing schedule for patients and their families. We will conduct a prospective, open, 3-arm, non-inferiority trial of peanut OIT in children 3–8 years of age; the primary outcome is passing an end-of-study (24 months) oral challenge to a serving size of peanut protein. Mechanistic studies of changes in B cell receptors and basophil activation will explore novel biomarkers for assessing long-term tolerance. For our center-specific project, we hypothesize that EoE and IgE-FA are driven by environmental exposures that abrogate the aryl hydrocarbon (AHR) pathway; we propose to investigate the mechanism of AHR function, therapeutic potential of esophageal delivery of AHR ligand- producing bacteria, and metabolic composition of AHR ligands in food allergies, intersecting the AHR ligand composition with cellular and molecular profiles of the epithelium and atopic manifestations.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $380,000 )
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Allergy and Infectious Diseases Research	000	3	4/24/2026	NON-COMPETING CONTINUATION	$380,000
														Subtotal = $380,000

Issue Date FY: 2025 ( Subtotal = $380,000 )
2025	2025	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Allergy and Infectious Diseases Research	000	2	4/14/2025	NON-COMPETING CONTINUATION	$380,000
														Subtotal = $380,000

Issue Date FY: 2024 ( Subtotal = $380,000 )
2024	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Allergy and Infectious Diseases Research	000	1	3/1/2024	NEW	$380,000
2024	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Allergy and Infectious Diseases Research	001	1	3/4/2024	NEW	$0
														Subtotal = $380,000

Grand Total All Awards = $1,140,000

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Consortium of Food Allergy Research Clinical Research Center at Cincinnati Children's Hospital Medical Center (CoFAR-CRC:CCHMC)

Award Number: U01AI181966

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/01/2024

PERIOD OF PERFORMANCE END DATE: 02/28/2031

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