Vanderbilt University Medical Center (VUMC) CoFAR Clinical Research Center

PROJECT SUMMARY/ABSTRACT This application is in response to RFA-AI-22-076 to establish a Clinical Research Center at Vanderbilt University Medical Center for the Consortium of Food Allergy Research. The goal of this application is to establish the infrastructure for a CRC that will then successfully, efficiently, and rigorously conduct both CoFAR-wide clinical

studies along with advancing the science and understanding of the food allergy syndrome related to alpha-gal. These goals will be pursued via the following specific aims: Specific Aim 1: Establish infrastructure for the VUMC CoFAR CRC, which is capable of rapidly implementing and executing single site and multi-center clinical trials, with high quality and fidelity, focused on the prevention

and management of patients with food allergy, supplemented by studies to better elucidate the mechanisms underlying food allergies and, in particular, alpha-gal syndrome. This CRC will serve as an opportunity for New and Early-Stage Investigators to contribute to these projects and advance their independent research careers.

Specific Aim 2: Develop and conduct a consortium-wide, multi-center, non-inferiority clinical trial to evaluate the comparative effectiveness of early peanut introduction with once weekly peanut feeding (low weekly peanut protein dose, 2 gm) versus thrice weekly peanut feedings (standard weekly peanut protein dose, 6 gm) in the

prevention of peanut allergy in at risk infants. Specific Aim 3: Based upon the concept that alpha-gal syndrome (AGS) is clinically manifest as a wide spectrum of clinical presentations, we aim to better understand (1) why some patients in tick-endemic areas develop clinically evident AGS after a bite, while others do not, and (2) why the clinical expression of AGS is variable

amongst patients and changes over time.