Oral Peanut Immunotherapy for Peanut Allergic Patients

Early Phase 1

Completed

• Conditions: Peanut Hypersensitivity
• Interventions: Drug: Peanut protein

• Registration Number: NCT01891136
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize peanut allergic patients to peanuts in order prevent peanut allergic reactions.

Detailed Description

The goal of this proposal is to develop peanut OIT for patients with peanut allergic reactions. This approach is designed to utilize our 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 (IT) have been unsuccessful primarily because of the side effects of therapy.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-02
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Subjects between 1 and 16 years of age
• Diagnosed peanut allergy by either: 1) a positive prick skin test to peanut, CAP FEIA of 15 or greater and a history of significant clinical symptoms within one hour after ingestion of peanuts or 2) a positive prick skin test to peanut, CAP FEIA of ≥ 7 and a history of a clinical reaction to peanut ingestion within the past 6 months.
• A family that will be able to be compliant with all study visits.

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Exclusion Criteria

• Subjects with a history of severe anaphylaxis to peanut
• Subjects with a medical history that would prevent a DBPCFC/OFC to peanut The medical history that would prevent the DBPCFC to peanut would be a prior history of an open peanut challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an forced expiratory volume in 1 second (FEV1) < 80% of predicted, or FEV1/FVC (forced vital capacity) < 75%, with or without controller medications
• Subjects unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
• Pregnant or lactating
• Allergy to oat

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peanut protein	Peanut protein	Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy.

Primary Outcome Measures

Name	Time	Method
The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of OIT.	2 to 5 years	Clinical desensitization will be measured with an oral food challenge (OFC) to peanut conducted while on OIT therapy.
Clinical desensitization will be measured with an oral peanut challenge conducted while on OIT therapy.	2 to 5 years	Clinical tolerance will be measured with an oral peanut challenge conducted four weeks after discontinuing OIT.

Secondary Outcome Measures

Name	Time	Method
Changes in number of antigen-specific lymphocytes.	2 to 5 years	The investigators will examine the role of OIT on peanut-specific T cell responses by enumerating specific T cell subsets, including T regulatory cells, pre- and post-treatment.
Changes in function of antigen-specific lymphocytes.	2-5 years	The investigators will examine the role of OIT on peanut-specific T cell responses by analyzing cell signaling, gene expression, and cytokine production, pre- and post-treatment.

Trial Locations

Locations (1)

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States