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Oral Peanut Immunotherapy (PNOIT)

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ClinicalTrials.gov Identifier: NCT01324401
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : January 20, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 12, 2010
First Posted Date  ICMJE March 29, 2011
Results First Submitted Date  ICMJE November 23, 2016
Results First Posted Date  ICMJE January 20, 2017
Last Update Posted Date August 8, 2018
Actual Study Start Date  ICMJE March 2011
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2011)
Tolerance [ Time Frame: at least 36 months ]
Tolerance will be defined in this study as a loss of clinical sensitivity to peanut. Subjects will be considered to have achieved tolerance if the post treatment eliciting dose (ED), defined by the double blind placebo controlled food challenge, is five fold increase from the ED of baseline.
Change History Complete list of historical versions of study NCT01324401 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2017)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2011)
  • Desensitization [ Time Frame: at least 36 months ]
    A five-fold increase in ED defined by OFC at the conclusion of maintenance therapy
  • The frequency of side-effects and their relationship to other variables [ Time Frame: at least 36 months ]
  • A significantly lower frequency of accidental ingestion reactions compared to controls [ Time Frame: at least 36 months ]
  • A longitudinal suppression of end-point skin testing by 2 log dilution. [ Time Frame: at least 36 months ]
  • A longitudinal suppression of peanut-specific basophil activation by 1.5 log dilution [ Time Frame: at least 36 months ]
  • A longitudinal doubling of peanut-specific IgG4 [ Time Frame: at least 36 months ]
  • A longitudinal increase of Ara h 2-specific IgG+ B cells by >1.5 SD [ Time Frame: at least 36 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Peanut Immunotherapy
Official Title  ICMJE Oral Peanut Immunotherapy
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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 treatment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Condition  ICMJE Peanut Allergy
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Peanut flour OIT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2016)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2011)
32
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Diagnosis of peanut allergy by a positive prick skin test to peanut (> 8 mm reaction wheal) or CAP FEIA >10 and a history of objective clinical symptoms within one hour after ingestion of peanuts
  2. Ability to provide informed consent.
  3. Males and females of all ethnic/racial groups between 7 and 21 years who are otherwise healthy.

Exclusion criteria:

  1. Clinical history of a severe anaphylactic reaction known or suspected to be caused by ingestion of peanut that required treatment with 2 or more administrations of epinephrine or hospitalization
  2. Moderate to Severe Asthma as defined using the Impairment or Risk Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
  3. Poorly controlled Asthma as defined using the Control Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
  4. Diagnosis of other severe or complicating medical problems
  5. Autoimmune or chronic immune or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
  6. Primary Immune Deficiency
  7. Use of beta blockers, angiotension converting enzyme inhibitors, or monoamine oxidase inhibitors
  8. Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
  9. Use within the past year of other systemic immunomodulatory treatment, including allergen immunotherapy, use of biologics with an immune target, including Xolair
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01324401
Other Study ID Numbers  ICMJE 2010P000609
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wayne G Shreffler, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP