Oral Peanut Immunotherapy

Not Applicable

Completed

• Conditions: Peanut Allergy
• Interventions: Drug: Peanut flour OIT

• Registration Number: NCT01324401
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Peanut allergy is one of the most serious food allergies because of its life long persistence, and the potential for severe allergic reactions. Effective oral immunotherapy would benefit patients by reducing the likelihood that they will have life-threatening accidental allergic reactions. This research study is being done to develop an effective oral immunotherapy treatment for patients with peanut allergy.

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:

1. Induce desensitization in peanut allergic subjects with peanut OIT and evaluate the safety of the peanut OIT desensitization protocol.

2. Induce long-standing tolerance in peanut allergic subjects with maintenance peanut OIT and evaluate the efficacy of allergen-specific testing to predict tolerance.

3. Longitudinally evaluate basophil and mast cell reactivity in subjects receiving peanut OIT and their relationship to the induction of desensitization.

4. Longitudinally evaluate the allergen-specific B-cell repertoire in subjects receiving peanut OIT and its relationship to the induction of tolerance.

Study Timeline

• Study First Submitted: 2010-08-12
• Study Start: 2011-03
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Primary Completion: 2016-05
• Results First Submitted: 2016-11-23
• Results First Submitted QC: 2016-11-23
• Results First Posted: 2017-01-20
• Study Completion: 2018-05
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peanut OIT	Peanut flour OIT	The subjects randomized to the active treatment group will receive defatted peanut flour per protocol.

Primary Outcome Measures

Name	Time	Method
Tolerance or Sustained Unresponsiveness	at least 36 months	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

Secondary Outcome Measures

Name	Time	Method
Desensitization	at least 36 months	The consumption of 5 grams of peanut protein during an open food challenge without objective symptoms immediately post treatment

Trial Locations

Locations (1)

Food Allergy Center; Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States