Oral Peanut Immunotherapy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Tolerance or Sustained Unresponsiveness
Overview
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:
- Induce desensitization in peanut allergic subjects with peanut OIT and evaluate the safety of the peanut OIT desensitization protocol.
- Induce long-standing tolerance in peanut allergic subjects with maintenance peanut OIT and evaluate the efficacy of allergen-specific testing to predict tolerance.
- Longitudinally evaluate basophil and mast cell reactivity in subjects receiving peanut OIT and their relationship to the induction of desensitization.
- Longitudinally evaluate the allergen-specific B-cell repertoire in subjects receiving peanut OIT and its relationship to the induction of tolerance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Open Label
Eligibility Criteria
- Ages
- 7 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Peanut OIT
The subjects randomized to the active treatment group will receive defatted peanut flour per protocol.
Intervention: Peanut flour OIT (Drug)
Outcomes
Primary Outcomes
Tolerance or Sustained Unresponsiveness
Time Frame: 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 Outcomes
- Desensitization(at least 36 months)
Investigators
Wayne G. Shreffler, MD, PhD
Principal Investigator, Center for Immunology and Inflammatory Diseases; Director, Food Allergy Center
Massachusetts General Hospital