PROJECT SUMMARY/ABSTRACT
Food allergy affects an estimated 26 million American adults and 5.6 million children. The Consortium for Food
Allergy Research (CoFAR) is a network of clinical research centers who work together to conduct clinical
research to advance understanding of food allergy and the care of food-allergic patients. The University of North
Carolina Food Allergy Initiative (UNCFAI) Clinical Research Center (CRC) is a leader in food allergy research,
clinical care, and education. Under the leadership of Drs. Edwin Kim and Corinne Keet, the UNCFAI CRC will
leverage the well-established infrastructure and resources available at the UNCFAI to conduct high quality
clinical research in food allergy. The specific aims are to: (1) Develop a flexible and collaborative CoFAR Clinical
Research Center to efficiently initiate, enroll, and implement multi-center trials in conjunction with the consortium,
(2) Establish sustainable CRC operations through mentorship, leadership training, and research opportunities
for junior investigators, (3) Propose a network-wide trial building on the strengths of the UNCFAI and the broader
CoFAR network to advance treatment of food-allergic patients and (4) Perform high-yield CRC-specific research
projects that expand UNCFAI research capabilities, provide opportunities for junior investigators, and inform
future CoFAR research. As part of the application, the UNCFAI proposes a multi-center, randomized, placebo-
controlled trial to evaluate the safety and efficacy of peanut and cashew multi-food sublingual immunotherapy in
young children. Biosamples from this study will illuminate the local and systemic mechanisms of sublingual
immunotherapy (SLIT). In addition, the UNCFAI will conduct two site specific research projects. Project 1 will
take and analyze biosamples from a recently completed randomized, placebo-controlled trial of peanut SLIT in
young children in order to identify predictors of response to SLIT and explore the mechanisms of desensitization
and remission. Project 2 will create a prospective longitudinal registry of food-allergic patients in order to define
phenotypes of food allergy, attitudes and preferences about food allergy management, and predictors of food-
allergic reactions. These projects will inform future larger studies of food allergy while serving as training
opportunities for junior investigators to ensure that UNCFAI remains a highly productive and sustainable CoFAR
CRC.