Clinical trial NCT01891136: Oral Peanut Immunotherapy for Peanut Allergic Patients
Official title: Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Peanut Hypersensitivity
Keywords: Peanut allergy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-07-02
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of OIT.
timeFrame: 2 to 5 years
measure: Clinical desensitization will be measured with an oral peanut challenge conducted while on OIT therapy.
timeFrame: 2 to 5 years
Secondary outcomes:
measure: Changes in number of antigen-specific lymphocytes.
timeFrame: 2 to 5 years
measure: Changes in function of antigen-specific lymphocytes.
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Wesley Burks, MD
role: PRINCIPAL_INVESTIGATOR
References: