FARE Peanut SLIT and Early Tolerance Induction
Condition: Peanut Hypersensitivity; Food Allergy; Food Hypersensitivity; Peanut Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
Intervention: Liquid Peanut Extract; Placebo Glycerin SLIT
Intervention description: 5000mcg/ml peanut protein; pure glycerinated saline solution with caramel coloring to match color
Intervention MeSH terms: Glycerol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 12 Months
Maximum age: 48 Months
Healthy volunteers: No
Keywords: Peanut; Food Allergy

Summary:

      Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in
      subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this
      objective will be a statistically significant difference in challenge scores between the
      treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food
      challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are
      measured by the amount of peanut protein participants are able to ingest successfully without
      symptoms of an allergic reaction. [Time Frame: Baseline, 36 months]

      Secondary Objectives:

      A secondary outcome of this objective will be a statistically significant difference in the
      challenge score of the treatment group versus the placebo group during the DBPCFC performed 3
      months after discontinuing therapy (tolerance).

      To examine the change in immune parameters associated with peanut SLIT and the development of
      clinical tolerance. Through this objective, the investigators will seek to understand the
      molecular processes by which SLIT affects the immune system through evaluation of immune
      mechanisms in relationship to clinical findings of desensitization and tolerance. The
      investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral
      responses to peanut protein.

      [Time Frame: Baseline, 39 months]
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent from participant's parent/guardian.

          -  Age 12-48 months of either sex, any race, any ethnicity.

          -  A peanut allergy diagnosis with a convincing clinical history of peanut allergy and a
             serum peanut-specific IgE [UniCAP] > 0.35 kUA/L AND a positive skin prick test to
             peanut (>3 mm than the negative control) OR are sensitized to peanut (based on a serum
             IgE [UniCAP] to peanut of > 5 kUA/L) AND a positive skin prick test to peanut (> 3 mm
             than the negative control) and no known history of ingestion of peanut.

          -  A positive DBPCFC to 1000 mg of peanut at enrollment.

        Exclusion Criteria:

          -  History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or
             neurologic compromise (cyanosis or peripheral capillary oxygen saturation (SpO2) < 92%
             at any stage, hypotension, confusion, collapse or loss of consciousness).

          -  Participation in any interventional study for the treatment of food allergy in the
             past 6 months.

          -  Known oat, wheat, or glycerin allergy.

          -  Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease.

          -  Severe asthma (2007 NHLBI Criteria Steps 5 or 6 - Appendix 2).

          -  Inability to discontinue antihistamines for skin testing and DBPCFCs.

          -  Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral
             or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic
             therapy within the past year.

          -  Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors,
             angiotensin-receptor blockers (ARB) or calcium channel blockers.

          -  Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular,
             hematologic, or pulmonary disease) which would make the subject unsuitable for
             induction of food reactions.