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: 10398330
• 负责人: A. Wesley Burks
• 金额: $ 577.06万
• 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/10398330
• 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; response; 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先者，包括疾病的最佳特征和 开发下一代治疗方法。下一个 CoFAR 将把食物过敏研究带入新的阶段 重点关注疾病表型和新方法的前沿临床和机制研究达到了顶峰 来预防和治疗。研究议程将首先基于尽可能最好的科学， 但为了最大限度地提高生产力，我们还需要明智地进行计划，以便利用所有可用资源 他们的最大能力。因此，研究议程需要仔细选择和阶段性的方案 不仅考虑到它们推进该领域的潜力，而且还仔细考虑了其他新颖的治疗方法 可能正在开发中，以及一项研究如何为下一项研究提供信息。最后，总体研究策略 还需要平衡 SACCC 和联盟中每个 CRU 的工作负载。 该计划的三个主要目标是：1) 快速实施食物过敏登记研究，该研究将提供 充分表征大量患者并对其进行表型分析、确定真实反应率的方法， 并作为临床试验的招募来源； 2）开发并实施一种新颖的、前沿的协议 使用用于治疗花生过敏的 DNA-LAMP 疫苗治疗食物过敏； 3) 选择和 制定加入联盟的附加协议，特别是与其他有前途的方法相关的协议 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资助期内启动和完成， 根据每项研究的规模、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，该议程将致力于将生物标志物基金和机会基金充分纳入每个项目中。 CoFAR 协议。如果成功，该研究议程不仅将定义 CoFAR 的未来 7 年，而且还将定义 为未来十年的食物过敏研究建立平台。