- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01324401
Oral Peanut Immunotherapy (PNOIT)
Study Overview
Detailed Description
Our hypothesis is that chronic antigen exposure during peanut oral immunotherapy (OIT) will induce beneficial changes in the specific immune response, including: 1) anergy of IgE effector immune cells (e.g., mast cells, basophils) resulting in clinical desensitization; 2) induction of de novo, long lived (memory) B cell responses that antagonize specific IgE and confer immune tolerance. The investigators will test this hypothesis in the following specific aims:
- Induce desensitization in peanut allergic subjects with peanut OIT and evaluate the safety of the peanut OIT desensitization protocol.
- Induce long-standing tolerance in peanut allergic subjects with maintenance peanut OIT and evaluate the efficacy of allergen-specific testing to predict tolerance.
- Longitudinally evaluate basophil and mast cell reactivity in subjects receiving peanut OIT and their relationship to the induction of desensitization.
- Longitudinally evaluate the allergen-specific B-cell repertoire in subjects receiving peanut OIT and its relationship to the induction of tolerance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Food Allergy Center; Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Diagnosis of peanut allergy by a positive prick skin test to peanut (> 8 mm reaction wheal) or CAP FEIA >10 and a history of objective clinical symptoms within one hour after ingestion of peanuts
- Ability to provide informed consent.
- Males and females of all ethnic/racial groups between 7 and 21 years who are otherwise healthy.
Exclusion criteria:
- Clinical history of a severe anaphylactic reaction known or suspected to be caused by ingestion of peanut that required treatment with 2 or more administrations of epinephrine or hospitalization
- Moderate to Severe Asthma as defined using the Impairment or Risk Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
- Poorly controlled Asthma as defined using the Control Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
- Diagnosis of other severe or complicating medical problems
- Autoimmune or chronic immune or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
- Primary Immune Deficiency
- Use of beta blockers, angiotension converting enzyme inhibitors, or monoamine oxidase inhibitors
- Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
- Use within the past year of other systemic immunomodulatory treatment, including allergen immunotherapy, use of biologics with an immune target, including Xolair
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
The subjects randomized to the observational control group will have follow-up visits every 6 months.
Each visit will involve a medical history and physical examination.
These subjects are then offered to cross-over to active treatment.
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Experimental: Peanut OIT
The subjects randomized to the active treatment group will receive defatted peanut flour per protocol.
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Patients will receive daily escalating dosages (Peanut flour OIT) as determined in the modified rush phase as stated in the protocol.
The dosage will be escalated until a daily dose of 4000 mg is reached.
A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day.
One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food.
The other challenge will consist of placebo material given similarly.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerance or Sustained Unresponsiveness
Time Frame: at least 36 months
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The consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance
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at least 36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Desensitization
Time Frame: at least 36 months
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The consumption of 5 grams of peanut protein during an open food challenge without objective symptoms immediately post treatment
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at least 36 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010P000609
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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