Mucosal Immunotherapy for Peanut Allergy in Young Children (DEVIL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00932828
First received: July 2, 2009
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed with peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).


Condition Intervention Phase
Food Hypersensitivity
Drug: Peanut and placebo flour
Drug: Peanut protein flour
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • To treat peanut-allergic subjects with PMIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes long-term tolerance. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the effect that PMIT has on the peanut-specific cellular and humoral response in peanut-allergic subjects. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose peanut protein
Subject will be randomized to receive a low dose of peanut protein mixed with a placebo protein.
Drug: Peanut and placebo flour
Peanut flour mixed with placebo will be given in gradually increasing doses.
Experimental: High dose peanut protein
Subject will be randomized to receive a high dose of peanut protein.
Drug: Peanut protein flour
Peanut flour will be given in gradually increasing doses.
No Intervention: Historical Control
This group will be followed for the same amount of time as the active subjects, to observe the natural history of peanut allergy.

Detailed Description:

Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies, it tends to be more persistent and its prevalence seems to be rising. Currently, there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut mucosal immunotherapy (PMIT). We are also studying the effect of PMIT on the peanut-specific immune response to determine if tolerance to peanut protein will develop. Based on our preliminary work and recent studies supporting the importance of early oral exposure in tolerance induction, we propose that early treatment of peanut allergy with PMIT will be safe and effective. Children ages 9 to 36 months with peanut allergy will be randomized to receive high or low dose PMIT using peanut flour. Peanut-allergic subjects receiving no intervention will serve as controls. Subjects will undergo desensitization on the first day and then increase the doses gradually to a maintenance dose. Doses will be taken daily at home except for dose increases which will be done on the research unit. Subjects will undergo a double-blinded, placebo-controlled food challenge (DBPCFC) if challenge criteria are met. Subjects passing the first challenge will stop PMIT and repeat the DBPCFC to assess tolerance. Outcome variables of interest include response to oral food challenges (OFC), skin prick testing, peanut specific serum immunoglobin E (IgE), immunoglobin G (IgG), and immunoglobin G4 (IgG4) and stool immunoglobin A (IgA), T and B cell responses, quality of life, and adverse events. These longitudinal results will be compared between high and low dose PMIT groups and controls using appropriate statistical analysis.

  Eligibility

Ages Eligible for Study:   9 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 9-36 months of either sex, any race, any ethnicity at the time of the initial visit
  • EITHER a positive skin prick test to peanuts or in vitro [CAP-FEIA] peanut immunoglobin E (IgE) level in the blood > 0.35 kU/L PLUS a history of a clinical allergic reaction (defined as significant clinical symptoms occurring within 60 minutes after ingesting peanuts) within 6 months of screening
  • OR a positive prick skin test to peanuts and in vitro [CAP-FEIA] peanut IgE level > 5 kU/L when there is no history of allergic reaction and no known peanut exposure
  • Provision of signed informed consent
  • Development of symptoms characteristic of IgE-mediated food allergy (urticaria, angioedema, respiratory distress/wheeze/cough, vomiting/diarrhea, anaphylaxis) during initial oral food challenge

Exclusion Criteria:

  • History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise
  • Currently participating in a study using an investigational new drug
  • Participation in any interventional study for the treatment of food allergy in the past 12 months
  • Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
  • Severe atopic dermatitis
  • Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines
  • Inability to discontinue antihistamines for skin testing and OFCs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932828

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Arvil W Burks, MD University of North Carolina
  More Information

No publications provided

Responsible Party: Wesley Burks, MD, Chairman, Department of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00932828     History of Changes
Other Study ID Numbers: 00016160
Study First Received: July 2, 2009
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
Peanut allergy

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 22, 2014