Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Intervention: Peanut oral immunotherapy
Intervention description: Defatted peanut in flour form to be used as treatment for peanut allergy
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Masking description: For exploratory analysis, subjects will be randomized 1:1 to high (3000mg) and low dose (300mg) OIT to potentially look for a dose response. Low dose will be masked by adding oat flour to provide a dose equal to high dose with respect to flour but with lower peanut protein content
Enrollment: 37.0
Sex: All
Minimum age: 9 Months
Maximum age: 36 Months
Healthy volunteers: No
Keywords: Peanut allergy

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).
    

Eligibility 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