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

西奈山的 COFAR 临床研究单位和临床试验（“ADVANCE”试验）。

• 批准号: 10589847
• 负责人: SCOTT H SICHERER
• 金额: $ 23.5万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-05 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10589847
• 关键词: Adjuvant; Adult; Affect; Area; Biological; Biological Markers; Child; Clinical Research; Clinical Trials; Combined Modality Therapy; Diagnostic; Dose; Food Hypersensitivity; Goals; Immune response; Immunologics; Immunotherapy; Ingestion; Intervention Studies; Intervention Trial; Leadership; Mentors; Milk; Multicenter Studies; National Institute of Allergy and Infectious Disease; Observational Study; Oral; Participant; Prevention; Prevention strategy; Protocols documentation; Quality of life; Registries; Research; Research Personnel; Resources; Sampling; Site; base; cost; egg; epidemiology study; experience; food allergen; food challenge; improved; laboratory facility; next generation; novel; omalizumab; prevent; recruit; side effect; treatment strategy; treatment trial

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.

西奈山的CoFAR临床研究单位和临床试验（“ADVANCE”试验） 食物过敏影响高达8%的儿童和大约5%的成年人，是食品质量的重大负担。 生命，是昂贵的，而且可能是致命的。在确定潜在的治疗方法方面取得了重大进展， 预防战略。口服（OIT）、舌下（SLIT）和表皮（EPIT）免疫治疗，以及 使用OIT和奥马珠单抗的联合治疗，以及简单地让孩子对鸡蛋或牛奶有反应 如果可能的话，摄入大量加热的形式，都显示出改善治疗的希望。然而，局限性 这些方法，包括可变的疗效，副作用，成本和缺乏持续的无反应性 停止治疗表明需要更好的治疗方法。在预防方面取得了令人兴奋的进展，特别是 花生的早期引进，最近已经注意到。然而，还需要做更多的工作， 有效的预防战略。食物过敏研究联盟（CoFAR）的目标是 在治疗和预防食物过敏方面进行突破性的试验和研究，并将 机械研究。CoFAR的长期目标是制定有效的战略， 食物过敏，并阐明潜在的免疫机制。西奈山的主要目标 CoFAR临床研究单位（CRU）将为CoFAR提供出色的研究机会，并提出 临床试验，以实现上述目标。西奈山CRU团队已经成功安全地 自1997年以来一直从事食物过敏研究。它为上述每项干预性研究做出了贡献， 并拥有广泛的附加临床研究组合。该CRU PI，斯科特Sicherer，医学博士，带来了广泛的 曾担任所有既往CoFAR干预性试验的研究中心PI，以及 CoFAR观察性临床研究。他还带来了丰富的经验，从无数领域的食品 过敏研究，包括额外的治疗试验、登记、诊断和生活质量， 流行病学研究，并一直是许多食物过敏研究人员的导师。合作研究者Dr. Wang和Bunyavanich曾在临床试验中担任成功的PI。两名早期调查人员正在 团队，并将受益于他们的参与，成为下一代的领导者在食物过敏 research.西奈山实验室设施一直是CoFAR和其他多中心生物标志物的核心。 研究，并可以在领导中心（LC）的指导下轻松管理生物样本。安装 Sinai CRU位于曼哈顿，可以接触到广泛的潜在参与者; 进行了超过20，000次口服食物挑战，并在研究招募和保留方面拥有出色的记录。到 为了增加为CoFAR的目标做出贡献的机会，提出了一项临床试验， 结合低剂量食物过敏原与佐剂的产品（增强有利的免疫反应）。在 总之，西奈山CoFAR CRU带来了广泛的资源和经验，以确保实现 在立法委员会、指导委员会和国家机构间工业发展研究所的指导下，与CoFAR举行会议。