SUBLINGUAL IMMUNOTHERAPY FOR PEANUT ALLERGY

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 1/29/2008 这是一项多中心、1：1随机、双盲、安慰剂对照的试验，通过第44周的5 gm口服食物挑战（OFC），研究每日花生舌下免疫疗法（SLIT）对花生过敏的安全性和免疫学效果。主要目标是确定花生过敏受试者每天舌下含服花生蛋白是否会诱导花生脱敏作用增加，这是在治疗44周后以及大约1年、2年和3年的总维持SLIT治疗后通过OFC测量的。 次要目的如下： 1.） 确定能够耐受2100 mcg/天花生SLIT累积阶段的受试者百分比。 2.）的情况。 确定与初始剂量花生SLIT（每日维持2100 mcg花生蛋白）相比，“更高剂量”花生SLIT（每日维持3500 mcg花生蛋白）是否会导致OFC测定的花生脱敏差异。 3.）第三章 为了确定在维持花生SLIT约36个月后，花生脱敏和免疫学参数的变化是否是可持续的[“耐受性”诱导]，每天一次停止治疗8周，并发生功能性耐受。 4.）的情况。 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会使花生过敏的个体脱敏（增加他们在治疗时摄入花生的能力），并且在长期治疗后会诱导对花生的耐受性（在停止治疗时摄入花生的永久能力）。

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).