Oral Peanut Immunotherapy for Peanut Allergic Patients

Peanut Hypersensitivity Clinical Trial

— PnOIT  

Official title:

Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891136
• Other study ID #: 11-2298
• Status: Completed
• Phase: Phase 0
• First received: May 24, 2013
• Last updated: June 24, 2015
• Start date: April 2004
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00598039

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Hypersensitivity

Intervention

Drug:
• Peanut protein
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.

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	No