Immunotherapy for Peanut Allergy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00429429
First received: January 30, 2007
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Allergy
Procedure: Sublingual immunotherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunotherapy for Peanut Allergy

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • A negative double-blind placebo controlled food challenge at the completion the two years of the study. [ Time Frame: When IgE level drops to less than or equal to 2 ku/L ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A change in the cytokine level between the baseline and each selected time point during the two years of the study. [ Time Frame: Drop in cytokine level ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: April 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drops of peanut protein
Subjects receiving the peanut sublingual peanut protein drops.
Procedure: Sublingual immunotherapy
Drops of peanut protein placed and held under the tongue for a specific time before swallowed.
Other Name: Peanut protein solution

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.

  Eligibility

Ages Eligible for Study:   6 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects between 6 and 35 years of age
  • Diagnosed with peanut allergy by positive prick skin test, CAP FEIA of 15 Ku/L or greater
  • History of significant clinical symptoms within one hour after ingestion of peanuts
  • Family's compliance with all study visits

Exclusion Criteria:

  • Subjects with medical history preventing a BDPCFC to peanut
  • Subjects unable to cooperate with challenge procedure
  • Subjects unable to be reached by telephone for follow-up
  • Subjects with a history of severe anaphylaxis to peanut
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429429

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Wesley Burks, MD University of North Carolina
  More Information

Publications:
Sampson HA. Food allergy. J Allergy Clin Immunol 1989; 84(6 Pt 2):1062-7.
Cohen J. Statistical power analysis for the behavioral sciences. 2nd edition ed. Hillsdale, NJ: Erlbaum, 1988.

Responsible Party: Wesley Burks, MD, Chairman, Department of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00429429     History of Changes
Other Study ID Numbers: 1 R21-AT-002557-02
Study First Received: January 30, 2007
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Peanut allergy

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 23, 2014