Oral Immunotherapy for Childhood Egg Allergy
Condition: Hypersensitivity; Immediate Hypersensitivity; Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if oral immunotherapy (OIT) will desensitize a
      child with an allergy to egg and eventually lead to the development of tolerance to egg.
    

Detailed description: 
      In the United States, as many as 6% to 8% of children are affected by food allergy. In young
      children, allergic reactions to egg can range from mild rash to systemic anaphylaxis. The
      usual standard of care for allergy is complete avoidance of this food allergen and treatment
      of accidental systemic reactions by access to self-injected epinephrine. However, accidental
      exposure to allergens in processed foods may be difficult to avoid. Currently, several
      therapeutic strategies are being investigated to prevent and treat food allergies. Since
      standard injection (under the skin) immunotherapy for food allergy is associated with a high
      rate of allergic reactions, a few studies have recently tried oral immunotherapy (OIT) in
      food allergy. The purpose of this study is to determine the safety and efficacy of the
      administration of OIT. The intent is to develop desensitization and eventually tolerance to
      egg allergen. This study will evaluate tolerance to egg white solid that may be gained by
      gradually increasing the amounts of egg white solid given to a child over a long period of
      time.

      This study will last up to 48 months. The participants will be randomly assigned to receive
      oral immunotherapy treatment with egg white solid or placebo. This study will include dose
      escalation and maintenance followed by oral food challenge (OFC).

      For participants receiving egg OIT, visit 1 consists of multiple small incremental doses of
      egg white solid. This is followed by 32-40 weeks of gradual dose escalation to a stable
      maintenance dose of egg white solid for at least 8 weeks. At approximately Week 44,
      participants are given an OFC using 5 grams of egg white solid to identify desensitized
      individuals. Participants and study staff are unblinded following this initial OFC.
      Maintenance egg OIT therapy is continued for an additional 1-3 years. Oral Food Challenges
      with 10 grams of egg white solid will be performed for participants on maintenance egg OIT at
      subsequent time points (approximately Week 96 and annually thereafter) to test for
      desensitization. If passed, a repeat OFC after being off therapy for 4-6 weeks will be
      performed to test for tolerance. An OFC to test for tolerance will use 10 grams of egg white
      solid and be followed by an open feeding of egg.

      Participants receiving placebo during dose escalation and maintenance are given an OFC using
      5 grams of egg white solid to test for desensitization at approximately 44 weeks. They are
      unblinded at that time, continue on an egg-restricted diet, and are followed until up to 2
      years. These participants will only receive an OFC at a subsequent time point if their egg
      Immunoglobulin E (IgE) declines to be less than 2 kilounits of antibody per liter; this OFC
      will use 10 grams of egg white solid and be followed by an open feeding of egg.

      At selected visits, blood and urine collection, physical examination, prick skin tests, and
      atopic dermatitis and asthma evaluations will occur.
    

Intervention name(s): Egg oral immunotherapy; Control Group
Intervention type(s): Drug; Drug
Intervention description(s): Egg white solid powder; Placebo for egg white solid
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Egg Allergy; Egg Oral Immunotherapy (OIT); Food Allergy