Back to resultsOral Peanut Immunotherapy for Peanut Allergic Patients (PnOIT)
Primary Purpose
Peanut Hypersensitivity
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peanut protein
Sponsored by
About this trial
This is an interventional treatment trial for Peanut Hypersensitivity focused on measuring Peanut allergy
Eligibility 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
Sites / Locations
- UNC Chapel Hill
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peanut protein
Arm Description
Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01891136
First Posted
May 24, 2013
Last Updated
June 24, 2015
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT01891136
Brief Title
Oral Peanut Immunotherapy for Peanut Allergic Patients
Acronym
PnOIT
Official Title
Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Hypersensitivity
Keywords
Peanut allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peanut protein
Arm Type
Experimental
Arm Description
Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy.
Intervention Type
Drug
Intervention Name(s)
Peanut protein
Other Intervention Name(s)
Peanut OIT
Intervention Description
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.
Primary Outcome Measure Information:
Title
The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of OIT.
Description
Clinical desensitization will be measured with an oral food challenge (OFC) to peanut conducted while on OIT therapy.
Time Frame
2 to 5 years
Title
Clinical desensitization will be measured with an oral peanut challenge conducted while on OIT therapy.
Description
Clinical tolerance will be measured with an oral peanut challenge conducted four weeks after discontinuing OIT.
Time Frame
2 to 5 years
Secondary Outcome Measure Information:
Title
Changes in number of antigen-specific lymphocytes.
Description
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.
Time Frame
2 to 5 years
Title
Changes in function of antigen-specific lymphocytes.
Description
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.
Time Frame
2-5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley Burks, MD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Oral Peanut Immunotherapy for Peanut Allergic Patients
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