Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour)
Condition: Peanut Allergic Subjects
MeSH terms: Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Many children who are allergic to peanuts do not outgrow their allergy and have very severe
      allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing,
      decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A
      severe allergic reaction can lead to death if not treated appropriately.

      The purpose of this study is to find out if there is a way to treat children with peanut
      allergy to help lower the risk of severe allergic reactions and also cause them to lose their
      allergy to peanuts. The approach that will used for this study is a process called
      "desensitization".

      Oral immunotherapy involves eating gradually increasing amounts of a food over several
      months. This is a research study because at this time peanut oral immunotherapy (OIT) is
      investigational. Peanut OIT (study drug) is investigational because it is not currently
      approved for clinical use by the Food and Drug Administration. There are no alternative safe
      and effective treatments for peanut induced allergic reactions other than peanut avoidance
      and treatment with medications.
    

Detailed description: 
      This is a phase I, open label study for the initial 12 month desensitization phase of peanut
      oral immunotherapy and a 2 year maintenance phase. Subjects will be recruited to determine
      the immune response during the administration of peanut OIT after the development of disease.
      Cohort will include children age 5-16 years who have peanut allergy. The study will require
      approximately 36 visits with 3 phases: screening phase (~ 2 months); build-up phase (weeks 1
      year), followed by the maintenance phase (2 years).

      The primary objective of the OIT protocol is to desensitize subjects to peanut and this
      occurs over the first 12 months of the study (build-up phase). The first dose will be based
      on the amount at which the subject reacted during a double blind placebo controlled food
      challenge (DBPCFC). Thereafter, dose escalation would continue as outlined in the protocol
      for approximately 50 weeks until the maintenance dose of peanut protein (3900 mg) is reached.

      The maintenance phase will continue from the end of the build-up phase until approximately 24
      months. During this phase, the subject will switch to a peanut equivalent dose for the
      maintenance phase. At the conclusion of the maintenance phase a DBPCFC will be done. Negative
      challenges will be confirmed by open challenge. DBPCFC will be done.
    

Intervention name(s): Peanut Oral Immunotherapy (POIT)
Intervention type(s): Biological
Intervention description(s): The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.
Other intervention name(s): Peanut Flour; Peanut Oral Immunotherapy
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peanut Allergy; Anaphylaxis; Desensitization; Food Allergy; Oral Immunotherapy