FARE Peanut SLIT and Early Tolerance Induction
Summary
Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. \[Time Frame: Baseline, 36 months\] Secondary Objectives: A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance). To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. \[Time Frame: Baseline, 39 months\]
Timeline
- Start
- 2015-01
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
Outcome
Met primary endpoint
registry MEAN Peanut (Liquid Peanut Extract) SLIT: 4.9 (3.7 to 6.2) score on a scale NCT02304991 ↗
registry analysis (superiority test); Peanut (Liquid Peanut Extract) SLIT vs Placebo Glycerin SLIT; p = 0.002; t-test, 2 sided NCT02304991 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Liquid Peanut Extract | Protein / enzyme biologic | 5000 ug/ml | Other |