Oral Peanut Immunotherapy (PNOIT)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The observational control arm (parallel for the first year) was then offered to cross over to active treatmentMasking: None (Open Label)
Open LabelPrimary Purpose: Treatment
|Official Title:||Oral Peanut Immunotherapy|
- 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
- Desensitization [ Time Frame: at least 36 months ]The consumption of 5 grams of peanut protein during an open food challenge without objective symptoms immediately post treatment
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||May 2018|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
No Intervention: Control
The subjects randomized to the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. These subjects are then offered to cross-over to active treatment.
Experimental: Peanut OIT
The subjects randomized to the active treatment group will receive defatted peanut flour per protocol.
Drug: Peanut flour OIT
Patients will receive daily escalating dosages (Peanut flour OIT) as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324401
|United States, Massachusetts|
|Food Allergy Center; Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Wayne G Shreffler, MD, PhD||Massachusetts General Hospital|