Administrative Core

行政核心

基本信息

批准号：
8022462
负责人：
Hugh A Sampson
金额：
$ 22.59万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-07-01 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8022462
关键词：
Address Affect Allergic Allergic Reaction Allergy to eggs Allergy to peanuts American Anaphylaxis Asthma Biological Markers Candidate Disease Gene Child Clinical Clinical Trials Design Collaborations Communication Data Collection Development Disease Elements Engineering Ensure Eosinophilic Esophagitis Food Food Hypersensitivity Funding Genetic Genetic Markers Genotype Goals Hypersensitivity IgE Immunologics Immunotherapeutic agent Immunotherapy Infant Ingestion Investigation Laboratory Personnel Mediating Milk Mission Monitor Multicenter Trials National Institute of Allergy and Infectious Disease Natural History Observational Study Oral Patients Peanuts - dietary Pediatric Hospitals Phase I Clinical Trials Phase II Clinical Trials Population Prevalence Prevention Production Proteins Recombinant Vaccines Recombinants Recruitment Activity Research Personnel Resources Role Safety Site Structure Study Subject Testing Therapeutic Therapy Clinical Trials Treatment Efficacy Universities Vaccines base cohort desensitization design efficacy testing egg experience high risk insight novel prevent response sublingual immunotherapy success

项目摘要

The prevalence of IgE-mediated food allergy has increased over the past 2 decades and food allergy now affects 3.5% to 4% of the U.S. population, and peanut allergy alone, which is the single leading cause of severe and fatal food-induced allergic reactions in the US, affects 1.5 million Americans and has doubled in prevalence in young children in the past decade. The reasons for this increase are unknown, but it is clear that current strategies for preventing the development of peanut allergy and the severe allergic reactions following accidental ingestion of peanuts are not effective. Similarly, eosinophilic esophagitis (EE), primarily a food hypersensitivity disorder in children, has increased in prevalence, its underlying mechanisms are poorly understood and efforts at prevention and treatment are unsatisfactory. Five years ago a Consortium consisting of investigators from five universities was formed to investigate the natural history and underlying immunologic mechanisms of IgE-mediated milk, egg and peanut allergy, and to test the efficacy of a novel recombinant peanut protein vaccine, EMP-123. In order to accomplish these objectives, a well-defined administrative structure was established. Although production issues delayed the availability of EMP-123, the Administrative Core was able to effectively directe the observational study and initiated 3 immunotherapeutic trials. In the expanded Consortium proposed here, the Administrative Core will continue to coordinate and facilitate interactions between study sites, the NIAID and SACC, and to optimize efforts to investigate basic immunologic mechanisms associated with the natural history of food allergy in our well established cohort, complete a Peanut SLIT trial underway, and evaluate the efficacy of two additional therapeutic strategies. With the addition of a new site, the Administrative Core will direct efforts to investigate the role of food allergy in EE, comparing and contrasting the natural history and immunologic and genetic markers of EE with those of IgE-mediated food allergy. With its demonstrated record of success, the combined resources of this new Consortium provide a unique opportunity to address the underlying basis of these growing disorders.

过去 20 年来，IgE 介导的食物过敏的患病率有所增加，现在食物过敏影响了 3.5% 至 4% 的美国人口，仅花生过敏就是导致 3.5% 至 4% 的美国人过敏的唯一主要原因在美国，严重且致命的食物引起的过敏反应影响了 150 万美国人，并且发病率增加了一倍。过去十年在幼儿中的患病率。这种增加的原因尚不清楚，但很明显目前预防花生过敏和严重过敏反应的策略误食花生后并无效果。同样，嗜酸性粒细胞性食管炎（EE），主要是儿童食物过敏症的患病率有所增加，其潜在机制是人们对此了解甚少，预防和治疗工作也不尽如人意。五年前，一个由五所大学的研究人员组成的联盟成立来进行调查 IgE 介导的牛奶、鸡蛋和花生过敏的自然史和潜在免疫机制，并测试新型重组花生蛋白疫苗 EMP-123 的功效。为了实现为了实现这些目标，建立了明确的行政结构。虽然生产问题延迟了 EMP-123 的可用性，行政核心能够有效地指导观测研究并启动了 3 项免疫治疗试验。在此提议的扩大联盟中，行政核心将继续协调和促进研究中心、NIAID 和 SACC，并优化研究与自然相关的基本免疫机制的努力我们完善的队列中有食物过敏史，完成正在进行的花生SLIT试验，并评估两种额外治疗策略的功效。随着新站点的增加，管理核心将直接努力调查食物过敏在 EE 中的作用，比较和对比自然史以及 EE 和 IgE 介导的食物过敏的免疫学和遗传标记。凭借其已取得的成功记录，这个新联盟的综合资源提供了解决这些生长障碍的根本原因的独特机会。