Immunotherapy for Peanut Allergy

June 16, 2016 updated by: Wesley Burks, MD, University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Peanut protein solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
When IgE level drops to less than or equal to 2 ku/L

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Drop in cytokine level

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

January 30, 2007

First Submitted That Met QC Criteria

January 30, 2007

First Posted (Estimate)

January 31, 2007

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21AT002557-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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