Oral Peanut Immunotherapy for Peanut Allergic Patients (PnOIT)

Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients

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.

Study Overview

• Status: Completed
• Conditions: Peanut Hypersensitivity
• Intervention / Treatment: Drug: Peanut protein

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peanut protein; Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy.	Drug: Peanut protein; Subjects will receive increasing amounts of peanut protein over the modified rush phase and the build-up phase of the protocol. Once the subject reaches the maintenance phase of the study, they will remain on that dose until they reach the oral food challenges at the end of the study.; Other Names: Peanut OIT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in number of antigen-specific lymphocytes.	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.	2 to 5 years
Changes in function of antigen-specific lymphocytes.	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.	2-5 years

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Wesley Burks, MD, UNC Chapel Hill

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 24, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (Estimate): July 2, 2013

Study Record Updates

• Last Update Posted (Estimate): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Peanut allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: 11-2298