Immunotherapy for Peanut Allergy
Condition: Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional

Summary: 
      Currently, when a food allergy is diagnosed, the "standard of care" is strict avoidance of
      the allergic food and ready access to self-injectable epinephrine. Yet, accidental ingestions
      do occur. Unfortunately, for a ubiquitous food such as peanut, the possibility of an
      inadvertent ingestion is great. It is estimated that over 50% of individuals who are allergic
      to peanuts will have an accidental reaction to peanuts over a 2-year period. The purpose of
      this study is to determine if peanut sublingual immunotherapy (SLIT) reduces the number
      and/or symptoms of accidental peanut ingestion in peanut allergic subjects. We would
      anticipate that the subjects on the peanut SLIT protocol would experience few adverse effects
      with accidental peanut ingestion over the course of the two years of SLIT. The primary
      endpoint to evaluate the effectiveness of SLIT will be a negative DBPCFC to peanuts (8 grams)
      at the completion of the two years of the study.
    

Detailed description: 
      Peanut allergy is one of the most serious of the immediate hypersensitivity reactions to
      foods in terms of persistence and severity of the reaction and appears to be a growing
      problem. Allergen-specific immunotherapy (IT) is currently being examined as a treatment
      option because of the persistence of this hypersensitivity reaction and the lack of effective
      treatment. An understanding of the molecular mechanisms of peanut-specific IT is vital to
      ensure the eventual, successful treatment of peanut-allergic patients.

      The goal of this proposal is to develop peanut immunotherapy (IT) for patients with peanut
      allergic reactions. This innovative application is designed to utilize the extensive
      knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic
      approach that would lower the risk of anaphylactic reactions and would down regulate
      peanut-specific T cells in peanut-allergic patients. Previous attempts to utilize
      peanut-specific immunotherapy have been unsuccessful primarily because of the severe side
      effects of therapy.

      The specific aim of the study is to desensitize/tolerize peanut-allergic subjects with peanut
      allergen-specific, sublingual immunotherapy (SLIT) and begin to determine the molecular
      mechanism of the peanut-specific T-cell response during SLIT.

      The hypothesis is that peanut SLIT will desensitize patients with peanut allergic reactions
      by the induction of peanut specific regulatory T cells resulting in immune modulation of the
      peanut allergic reaction.
    

Intervention name(s): Sublingual immunotherapy
Intervention type(s): Procedure
Intervention description(s): Drops of peanut protein placed and held under the tongue for a specific time before swallowed.
Other intervention name(s): Peanut protein solution
Intervention MeSH terms: Immunomodulating Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peanut allergy