Oral Peanut Immunotherapy for Peanut Allergic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients

Conditions
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Peanut Hypersensitivity

Intervention / Treatment
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* Drug: Peanut protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peanut protein<br>Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy. | Drug: Peanut protein<br>* 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.<br>* Other names: Peanut OIT;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peanut allergy