Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      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).
    

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) more commonly called oral immunotherapy (OIT). 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.
      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. As secondary and
      exploratory outcomes, these longitudinal results will be compared between high and low dose
      PMIT groups and controls using appropriate statistical analysis.
    

Intervention name(s): Peanut oral immunotherapy
Intervention type(s): Drug
Intervention description(s): Defatted peanut in flour form to be used as treatment for peanut allergy
Other intervention name(s): Peanut mucosal immunotherapy; Peanut OIT
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Intervention model: Single Group Assignment
Intervention model description: For the purposes of the primary outcome, all subjects will receive peanut OIT and represent a single group. For exploratory analysis, subjects will be randomized to high and low dose OIT to potentially look for a dose response.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peanut allergy