Oral Peanut Immunotherapy for Peanut Allergic Patients (PnOIT)

University of North Carolina (UNC)

Status and phase: Completed; Early Phase 1

Conditions: Peanut Hypersensitivity

Treatments: Drug: Peanut protein

Study type: Interventional

Funder types: Other

Identifiers

NCT01891136

11-2298

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Peanut protein

Experimental group

Description:

Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy.

Treatment:

Drug: Peanut protein