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: 10363631
• 负责人: A. Wesley Burks
• 金额: $ 1198.21万
• 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/10363631
• 关键词: Adverse reactions; Affect; Allergic Reaction; Allergy to peanuts; Asthma; Biological Markers; Child; Clinical; Clinical Protocols; Clinical Trials; DNA; Data; Development; Disease; Ensure; Equilibrium; Food; Food Hypersensitivity; Frequencies; Funding; Funding Opportunities; Future; Goals; 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; base; 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.

总结 本申请中描述的研究议程的总体目标是将CoFAR定位为 食物过敏研究的国际领导者，包括疾病的最佳表征， 下一代治疗方法的开发。下一个CoFAR将把食物过敏研究带到新的 尖端临床和机制研究的高度，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好的科学， 但为了最大限度地提高生产力，我们还需要明智地规划，以便所有可用资源都可以用于 他们的最大能力。因此，研究议程将需要仔细选择和阶段协议的基础上 不仅是因为它们有潜力推动这一领域的发展，而且还仔细考虑了其他新的治疗方法。 以及一项研究如何为下一项研究提供信息。最后是总体研究策略 还需要平衡SACC和联合体各CRU的工作量。 该计划的三个主要目标是：1）迅速实施食物过敏登记研究， 对大量患者进行充分表征和表型分析，确定真实反应率， 并作为临床试验的招募来源; 2）开发和实施一种新的，尖端的方案， 使用用于治疗花生过敏的DNA-LAMP疫苗治疗食物过敏;以及3）选择和 制定附加议定书，特别是与其他有希望的办法有关的附加议定书， 治疗或预防的发展。预计至少有3个协议，包括 临床试验和非干预性研究，将在七年的资助期内启动和完成， 根据每个研究的规模、持续时间和复杂性，这可能会增加到5个甚至6个方案。在 此外，该议程还将努力将生物标志物基金和机会基金充分纳入每一个项目， CoFAR协议。如果成功，这项研究议程将不仅定义未来7年的CoFAR，而且还将 为未来十年的食物过敏研究建立平台。