Oral Peanut Immunotherapy for Peanut Allergic Patients (PnOIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01891136
First received: May 24, 2013
Last updated: June 24, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Peanut Hypersensitivity
Drug: Peanut protein
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of OIT. [ Time Frame: 2 to 5 years ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 2 to 5 years ] [ Designated as safety issue: Yes ]
    Clinical tolerance will be measured with an oral peanut challenge conducted four weeks after discontinuing OIT.


Secondary Outcome Measures:
  • Changes in number of antigen-specific lymphocytes. [ Time Frame: 2 to 5 years ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 36
Study Start Date: April 2004
Study Completion Date: December 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Peanut OIT

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.

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01891136

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

No publications provided

Responsible Party: Wesley Burks, MD, Professor of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01891136     History of Changes
Obsolete Identifiers: NCT00598039
Other Study ID Numbers: 11-2298
Study First Received: May 24, 2013
Last Updated: June 24, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 30, 2015