Clinical Trial: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy

Brief Summary: The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.

Detailed Summary:

To effectively address the Primary Objectives of this pilot study, 30 subjects aged 6-21 years with: (1) a convincing clinical history of peanut allergy (PA), (2) a serum immunoglobulin E (IgE) specific to peanut of >0.35 kilo units per liter (kU/L) and a skin prick test (SPT) wheal >3 mm, will be enrolled. Subjects will be recruited from the Johns Hopkins Pediatric Allergy Clinic.

Participants will undergo an initial screening visit that will include a medical history, physical exam, skin testing, and phlebotomy. Informed consent and assent will be obtained. At the next two visits, 20 participants will complete a double-blind placebo-controlled food challenge (DBPCFC). Eligible subjects will be randomized in a 1:1 ratio into two groups. One group will receive active SLIT with placebo OIT and the other group will begin active OIT with placebo SLIT dose escalation. Over the next 16 weeks of the study, subjects will undergo SLIT and OIT dose increases. A maintenance dose will then be taken at home daily for 12 months. A DBPCFC will be completed after 6 months and 12 months of home dosing. Those patients who pass the DBPCFC will be taken off SLIT and OIT for 4 weeks. A final challenge will be administered at the end of this period.

Ten additional peanut-allergic subjects age 6-21 years will be enrolled and followed as longitudinal controls for the mechanistic studies. These subjects will follow a modified schedule compared to those subjects receiving study treatment and will be evaluated by phlebotomy, end point titration prick skin testing, and saliva collection. These patients will continue strict avoidance of peanut unless otherwise advised by their personal physician.


Sponsor: Johns Hopkins University

Current Primary Outcome: Number of Participants With Induced Peanut Desensitization at 12 Months [ Time Frame: 12 months ]

Peanut desensitization was defined as a greater than 10-fold increase in oral food challenge (OFC) threshold after 12 months of therapy.


Original Primary Outcome: The primary endpoint is to determine if sublingual administration of peanut extract and oral administration of peanut powder can induce a 10-fold increase in tolerance as measured by food challenge. [ Time Frame: 1 1/2 years ]

Current Secondary Outcome:

  • Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks) [ Time Frame: Baseline and end of dose build-up (up to 16 weeks) ]
    Serum immunoglobulin G4 (IgG4) levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at the end of dose build-up (up to 16 weeks)
  • Between Arm Change in IgG4 From Baseline to 6 Months [ Time Frame: Baseline and 6 months ]
    IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 6 months
  • Between Arm Change in IgG4 From Baseline to 12 Months [ Time Frame: Baseline and 12 months ]
    IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 12 months
  • Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks) [ Time Frame: Baseline to end of dose build-up (up to 16 weeks) ]
  • Between Arm Change in IgE From Baseline to 6 Months [ Time Frame: Baseline and 6 months ]
    Serum immunoglobulin E (IgE) levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 6 months
  • Between Arm Change in IgE From Baseline to 12 Months [ Time Frame: Baseline and 12 months ]
    IgE levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 12 months


Original Secondary Outcome:

  • The incidence of all serious adverse events on peanut SLIT and peanut OIT. [ Time Frame: 1 1/2 years ]
  • To assess any changes in clinical and mechanistic endpoints. [ Time Frame: 1 1/2 years ]
  • Peanut tolerance, as determined by oral food challenge (OFC) after being off daily SLIT and OIT for 4 weeks. [ Time Frame: 1 1/2 years ]


Information By: Johns Hopkins University

Dates:
Date Received: March 8, 2010
Date Started: March 2010
Date Completion:
Last Updated: February 23, 2017
Last Verified: February 2017