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.
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.
|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|
|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 137:1117-27.e1-10|
|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|
|Sicherer, Scott H; Wood, Robert A; Vickery, Brian P et al. (2014) The natural history of egg allergy in an observational cohort. J Allergy Clin Immunol 133:492-9|
|Kottyan, Leah C; Davis, Benjamin P; Sherrill, Joseph D et al. (2014) Genome-wide association analysis of eosinophilic esophagitis provides insight into the tissue specificity of this allergic disease. Nat Genet 46:895-900|
|Wood, R A; Sicherer, S H; Burks, A W et al. (2013) A phase 1 study of heat/phenol-killed, E. coli-encapsulated, recombinant modified peanut proteins Ara h 1, Ara h 2, and Ara h 3 (EMP-123) for the treatment of peanut allergy. Allergy 68:803-8|
|Wood, Robert A; Sicherer, Scott H; Vickery, Brian P et al. (2013) The natural history of milk allergy in an observational cohort. J Allergy Clin Immunol 131:805-12|
|Fleischer, David M; Burks, A Wesley; Vickery, Brian P et al. (2013) Sublingual immunotherapy for peanut allergy: a randomized, double-blind, placebo-controlled multicenter trial. J Allergy Clin Immunol 131:119-27.e1-7|
Showing the most recent 10 out of 19 publications