SUBLINGUAL IMMUNOTHERAPY FOR PEANUT ALLERGY

花生过敏的舌下免疫治疗

• 批准号: 7953722
• 负责人: SCOTT H SICHERER
• 金额: $ 0.81万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7953722
• 关键词: Allergic; Allergy to peanuts; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Development; Dose; Double-Blind Method; Food; Funding; Grant; Immunologics; Incidence; Individual; Ingestion; Institution; Maintenance; Measures; Oral; Peanuts - dietary; Placebo Control; Proteins; Randomized; Research; Research Personnel; Resources; Safety; Serious Adverse Event; Source; Staging; Sublingual drug administration; United States National Institutes of Health; desensitization; sublingual immunotherapy

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 1/29/2008 This is a multi-center, 1:1 randomized, double-blind, placebo-controlled, through the 5 gm Oral Food Challenge (OFC) at week 44, trial to investigate the safety and immunologic effects of daily peanut sublingual immunotherapy (SLIT) for peanut allergy. The primary objective is to determine in subjects with peanut allergy whether daily sublingual administration of peanut protein induces increased peanut desensitization as measured by OFCs after 44 weeks of therapy and after a total maintenance SLIT therapy of approximately 1, 2, and 3 years. The secondary objectives are as follows: 1.) To determine the percentage of subjects who tolerate the buildup stage to 2100 mcg/day of peanut SLIT. 2.) To determine if "higher-dose" peanut SLIT (3500 mcg daily maintenance of peanut protein), compared to the initial dose peanut SLIT (2100 mcg daily maintenance of peanut protein), results in the development of differences in desensitization to peanut as determined by OFC. 3.) To determine if, after approximately 36 months of maintenance peanut SLIT, the peanut desensitization and changes in immunologic parameters are sustainable ["tolerance" induction] once daily therapy is discontinued for 8 weeks and functional tolerance occurs. 4.) To characterize the safety of peanut SLIT by determining the incidence of all serious adverse events throughout the duration of the study. Hypothesis: Daily ingestion of small amounts of peanut protein will desensitize peanut-allergic individuals (increasing their ability to ingest peanut while on therapy) and after long term treatment will induce tolerance to peanut (a permanent ability to ingest peanut while off therapy).

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 2008年1月29日 这是一项多中心、1:1随机、双盲、安慰剂对照，通过第44周的5克口服食物挑战（OFC）试验，研究每日花生舌下免疫疗法（SLIT）治疗花生过敏的安全性和免疫学效果。主要目的是确定花生过敏受试者每天舌下含服花生蛋白是否会增加花生脱敏作用（根据治疗 44 周后以及大约 1、2 和 3 年的总维持 SLIT 治疗后通过 OFC 测量）。 次要目标如下： 1.) 确定耐受累积阶段至 2100 mcg/天花生 SLIT 的受试者百分比。 2.) 确定“较高剂量”花生 SLIT（每日维持 3500 微克花生蛋白）与初始剂量花生 SLIT（每日维持 2100 微克花生蛋白）相比，是否会导致 OFC 测定的花生脱敏差异的发展。 3.) 确定在维持花生SLIT约36个月后，一旦每日治疗停止8周并出现功能耐受，花生脱敏和免疫参数的变化是否可持续[“耐受”诱导]。 4.) 通过确定整个研究期间所有严重不良事件的发生率来表征花生 SLIT 的安全性。 假设： 每天摄入少量的花生蛋白将使花生过敏的个体脱敏（增加他们在治疗期间摄入花生的能力），并且在长期治疗后将诱导对花生的耐受性（在治疗结束时摄入花生的永久能力）。