Oral Peanut Immunotherapy (PNOIT)
|ClinicalTrials.gov Identifier: NCT01324401|
Recruitment Status : Active, not recruiting
First Posted : March 29, 2011
Results First Posted : January 20, 2017
Last Update Posted : August 14, 2017
|Condition or disease||Intervention/treatment|
|Peanut Allergy||Drug: Peanut flour OIT|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The observational control arm (parallel for the first year) was then offered to cross over to active treatment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Oral Peanut Immunotherapy|
|Study Start Date :||March 2011|
|Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||May 2018|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|