Mount Sinai's COFAR Clinical Research Unit and Clinical Trial (The "ADVANCE" Trial).

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MOUNT SINAI’S CoFAR CLINICAL RESEARCH UNIT AND CLINICAL TRIAL (THE “ADVANCE” TRIAL) Food allergy affects up to 8% of children and approximately 5% of adults, is a significant burden on quality of life, is costly, and can be fatal. Significant advances have been made in identifying potential treatment and prevention strategies. Oral (OIT), sublingual (SLIT), and epicutaneous (EPIT) immunotherapy, as well as combination therapy using OIT and omalizumab, and simply having children who are reactive to egg or milk ingest extensively heated forms if they can, have all shown promise to improve treatment. However, limitations of these approaches, including variable efficacy, side effects, costs, and lack of sustained unresponsiveness off treatment frame the need for better therapies. Exciting advances in prevention, specifically the efficacy of early introduction of peanut, have been recently noted. However, more needs to be done to identify the most effective prevention strategies. The objectives of the Consortium for Food Allergy Research (CoFAR) are to conduct ground-breaking trials and studies in treatment and prevention of food allergy, and to incorporate mechanistic studies. The long-term goals of CoFAR are to develop effective strategies to prevent and treat food allergies, and to elucidate underlying immunologic mechanisms. The major objective of the Mount Sinai CoFAR Clinical Research Unit (CRU) is to provide CoFAR with outstanding study opportunities and to propose a clinical trial to achieve the above stated goals. The Mount Sinai CRU team has been successfully and safely conducting food allergy research since 1997. It has contributed to every interventional study described above, and has an extensive portfolio of additional clinical studies. The CRU PI, Scott Sicherer, MD, brings broad experience having been site PI for all of the past CoFAR interventional trials, as well as being Protocol Chair of the CoFAR observational clinical study. He also brings extensive experience from a myriad of areas of food allergy research, including additional treatment trials, registries, diagnostics, and performing quality of life and epidemiologic research and has been a mentor to numerous food allergy investigators. Co-Investigators Drs. Wang and Bunyavanich have served as successful PIs on clinical trials. Two early stage investigators are on the team and will benefit from their involvement to become the next generation of leaders in food allergy research. The Mount Sinai laboratory facilities have been the biomarker core for CoFAR and other multicenter studies and can easily manage biological samples at the direction of the Leadership Center (LC). The Mount Sinai CRU is located in Manhattan, with access to an extensive base of potential participants; it has safely conducted >20,000 oral food challenges and has a superb record of study recruitment and retention. To increase opportunities to contribute to CoFAR’s goals, a clinical trial is proposed using a novel experimental product that combines low dose food allergen with an adjuvant (enhancing a favorable immune response). In summary, the Mount Sinai CoFAR CRU brings extensive resources and experience to ensure that the goals of CoFAR, at the direction of the LC, Steering Committee and NIAID, are met.