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: 1) peanut specific IgE, IgG, and IgG4 response, 2) peanut
specific basophil activation, 3) mast cell responses through skin prick testing, and 4)
specific T-cell cytokine responses and T regulatory cell (TReg) activation. The investigators
anticipate that the effect of peanut SLIT will occur by induction of TRegs, conversion of T
cells from an allergic (TH2) to a non-allergic (TH1) lymphocyte response (measured by
cytokines, antibody levels, and skin prick test size), a change in peanut-specific basophil
activation, or through a combination of the above.
[Time Frame: Baseline, 39 months]
Phase:
Phase 2
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Food Allergy Research & Education Food Allergy Research and Education (FARE) National Center for Complementary and Integrative Health (NCCIH) University of Texas Southwestern Medical Center