The Consortium of Food Allergy Research (CoFAR) Statistical and Clinical Coordinating Center (SACCC) will collaborate with the clinical research centers in supporting the development of clinical and mechanistic food allergy research activities. The Consortium will develop new approaches to treat and prevent IgE-mediated food allergy, including food allergy-associated anaphylaxis and food allergy-associated eosinophilic gastrointestinal disease (EGID). The goals will be to: (1) develop immune intervention strategies for prevention and treatment, (2) identify the mechanisms underlying the natural histories of these disorders, and (3) define the genetic components of these disorders. Multi-site, multi-protocol research will be developed and implemented using standardized and documented policies and procedures per U.S. federal regulation, ICH guidelines and Consortium practices to provide the highest level of security and protection to subjects participating in CoFAR observational and treatment studies. Pharmaceutical support will be provided to manufacturer, label, document and distribute investigational study products consistent with industry standards and an independent GMP review will occur prior to study activation. The SACCC will develop and institute training programs for the sites to conduct standardized study assessments that are key to study milestones, particularly with regards to enrollment and endpoint assessments. Data collection and submission standards will be provided using an electronic data management system, data quality tracked, site and safety monitoring reviewed and reported to the Steering Committee, DSMB and FDA. IND submissions will be supported for the duration of the project and the SACCC staff will collaborate with NIAID Office of Regulatory Affairs to support their sponsor files and FDA submission needs. Data will be analyzed for interim reports, abstracts and eventually published in peer reviewed journals and information disseminated to the medical community and public at large. At project completion, data will be provided to the NIH data repository.

Public Health Relevance

Food allergy is an immunologic disease responsible for substantial morbidity and mortality. Food allergy occurs in almost 4% of children and adults, and has a higher prevalence in children under age 4, and appears to be increasing in prevalence. Severe food allergic reactions may cause anaphylaxis and death. In the United States, there are approximately 14,000-30,000 annual anaphylactic episodes due to food allergic reactions. CoFAR was established from a Congressional mandate to identify immunological mechanisms in food allergy and develop related clinical studies to address this growing public health concern.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-WFD-I (M3))
Program Officer
Dong, Gang
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Emmes Corporation
United States
Zip Code
Berin, M Cecilia; Grishin, Alexander; Masilamani, Madhan et al. (2018) Egg-specific IgE and basophil activation but not egg-specific T-cell counts correlate with phenotypes of clinical egg allergy. J Allergy Clin Immunol 142:149-158.e8
Chehade, Mirna; Jones, Stacie M; Pesek, Robbie D et al. (2018) Phenotypic Characterization of Eosinophilic Esophagitis in a Large Multicenter Patient Population from the Consortium for Food Allergy Research. J Allergy Clin Immunol Pract 6:1534-1544.e5
Chiang, David; Chen, Xintong; Jones, Stacie M et al. (2018) Single-cell profiling of peanut-responsive T cells in patients with peanut allergy reveals heterogeneous effector TH2 subsets. J Allergy Clin Immunol 141:2107-2120
Watson, C T; Cohain, A T; Griffin, R S et al. (2017) Integrative transcriptomic analysis reveals key drivers of acute peanut allergic reactions. Nat Commun 8:1943
Agashe, Charuta; Chiang, David; Grishin, Alexander et al. (2017) Impact of granulocyte contamination on PBMC integrity of shipped blood samples: Implications for multi-center studies monitoring regulatory T cells. J Immunol Methods 449:23-27
Jones, Stacie M; Burks, A Wesley; Keet, Corinne et al. (2016) Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy. J Allergy Clin Immunol 137:1117-1127.e10
Bunyavanich, Supinda; Shen, Nan; Grishin, Alexander et al. (2016) Early-life gut microbiome composition and milk allergy resolution. J Allergy Clin Immunol 138:1122-1130
Sicherer, Scott H; Wood, Robert A; Vickery, Brian P et al. (2016) Impact of Allergic Reactions on Food-Specific IgE Concentrations and Skin Test Results. J Allergy Clin Immunol Pract 4:239-45.e4
Burks, A Wesley; Wood, Robert A; Jones, Stacie M et al. (2015) Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial. J Allergy Clin Immunol 135:1240-8.e1-3
Brough, Helen A; Liu, Andrew H; Sicherer, Scott et al. (2015) Atopic dermatitis increases the effect of exposure to peanut antigen in dust on peanut sensitization and likely peanut allergy. J Allergy Clin Immunol 135:164-70

Showing the most recent 10 out of 23 publications