NEW HORIZONS IN THE PREVENTION AND TREATMENT OF FOOD ALLERGY

预防和治疗食物过敏的新视野

• 批准号: 10581628
• 负责人: A. Wesley Burks
• 金额: $ 1349.33万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10581628
• 关键词: Adverse reactions; Affect; Allergic Reaction; Allergy to peanuts; Asthma; Biological Markers; Child; Clinical; Clinical Protocols; Clinical Trials; DNA; Data; Development; Disease; Equilibrium; Food; Food Hypersensitivity; Frequencies; Funding; Funding Opportunities; Future; Goals; Height; Immunologics; Immunotherapy; Industry; International; Investigation; Knowledge; Laboratories; Leadership; Longitudinal cohort study; Natural History; Oral; Phenotype; Population; Positioning Attribute; Prevalence; Prevention; Prevention approach; Process; Productivity; Protocols documentation; Reaction; Registries; Research; Resources; Science; Severities; Source; Staging; Treatment Protocols; Vision; Wood material; Work; Workload; comorbidity; desensitization; disease phenotype; innovation; next generation; novel; novel strategies; operation; patient population; phase 2 study; programs; protocol development; reaction rate; recruit; therapeutic vaccine; treatment response

Summary The overarching goal of the research agenda described in this application is to position CoFAR as the international leader in the study of food allergy, including optimal characterization of the disease and development of the next generation of treatments. This next CoFAR will bring food allergy research to new heights with cutting edge clinical and mechanistic studies focused on disease phenotypes and novel approaches to prevention and treatment. The research agenda will be based first and foremost on the best possible science, but to maximize productivity we will also need to plan judiciously so that all available resources can be used to their utmost capacity. Therefore, the research agenda will need to carefully select and stage protocols based not just on their potential to advance the field, but also with careful consideration regarding other novel treatments that may be under development, and how one study may inform the next. Finally, the overall research strategy will also need to balance the work load of the SACCC and each CRU in the consortium. The three major aims of this program are to: 1) rapidly implement a food allergy registry study that will provide the means to fully characterize and phenotype a large population of patients, determine true rates of reactions, and serve as a recruitment source for clinical trials; 2) develop and implement a novel, cutting edge protocol for the treatment of food allergy using a DNA-LAMP vaccine for the treatment of peanut allergy; and 3) choose and develop additional protocols for inclusion in the consortium, especially related to other promising approaches in development for either treatment or prevention. It is anticipated that a minimum of 3 protocols, including both clinical trials and non-interventional studies, will be initiated and completed over the seven-year funding period, and this could rise to 5 or even 6 protocols depending on the size, duration, and complexity of each study. In addition, the agenda will work to fully integrate the Biomarker Facility and the Opportunity Fund into each of the CoFAR protocols. If successful, this research agenda will define not just the next 7 years of CoFAR, but will also establish the platform for the next decade(s) of food allergy research.

概括 本应用中描述的研究议程的总体目标是将科法尔定位为 食物过敏研究的国际领导者，包括疾病的最佳特征和 下一代治疗的发展。下一个科法尔将把食物过敏研究带入新的 具有尖端临床和机械研究的高度，重点是疾病表型和新方法 预防和治疗。研究议程将首先基于最佳科学， 但是，为了最大化生产率，我们还需要明智地计划，以便所有可用的资源都可以用来 他们最大的能力。因此，研究议程将需要仔细选择和舞台协议 不仅有潜力推进该领域的潜力，而且还要仔细考虑其他新型治疗方法 这可能正在开发中，以及一项研究如何告知下一项。最后，总体研究策略 还需要在财团中平衡SACCC和每个CRU的工作负荷。 该计划的三个主要目的是：1）迅速实施一项将提供的食品过敏注册表研究 充分表征和表型的手段大量患者，确定真实的反应速率， 并充当临床试验的招聘来源； 2）开发和实施一个新颖的尖端协议 使用DNA-lamp疫苗治疗食物过敏，以治疗花生过敏； 3）选择和 开发其他方案以包含在财团中，尤其是与其他有前途的方法有关的 用于治疗或预防的开发。预计至少有3个协议，包括 临床试验和非差异研究将在七年的资金期间开始并完成 根据每项研究的大小，持续时间和复杂性，这可能会增加到5甚至6个方案。在 此外，议程将努力将生物标志物设施和机会基金完全整合到每个 Cofar协议。如果成功的话，这项研究议程将不仅定义了接下来的7年Cofar，还将定义 在未来十年的食物过敏研究中建立平台。