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Immunotherapy for Peanut Allergy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00429429
Recruitment Status : Completed
First Posted : January 31, 2007
Last Update Posted : June 20, 2016
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
Allergy Procedure: Sublingual immunotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy for Peanut Allergy
Study Start Date : April 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Peanut protein solution
Subjects receiving the peanut sublingual peanut protein drops. Sublingual Immunotherapy.
Procedure: Sublingual immunotherapy
Drops of peanut protein placed and held under the tongue for a specific time before swallowed.
Other Name: Peanut protein solution

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00429429

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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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Principal Investigator: Wesley Burks, MD University of North Carolina
Cohen J. Statistical power analysis for the behavioral sciences. 2nd edition ed. Hillsdale, NJ: Erlbaum, 1988.

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Responsible Party: Wesley Burks, MD, Chairman, Department of Pediatrics, University of North Carolina, Chapel Hill Identifier: NCT00429429    
Other Study ID Numbers: 1R21AT002557-02 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2007    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wesley Burks, MD, University of North Carolina, Chapel Hill:
Peanut allergy
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate