Immunotherapy for Peanut Allergy

Currently, when a food allergy is diagnosed, the "standard of care" is strict avoidance of the allergic food and ready access to self-injectable epinephrine. Yet, accidental ingestions do occur. Unfortunately, for a ubiquitous food such as peanut, the possibility of an inadvertent ingestion is great. It is estimated that over 50% of individuals who are allergic to peanuts will have an accidental reaction to peanuts over a 2-year period. The purpose of this study is to determine if peanut sublingual immunotherapy (SLIT) reduces the number and/or symptoms of accidental peanut ingestion in peanut allergic subjects. We would anticipate that the subjects on the peanut SLIT protocol would experience few adverse effects with accidental peanut ingestion over the course of the two years of SLIT. The primary endpoint to evaluate the effectiveness of SLIT will be a negative DBPCFC to peanuts (8 grams) at the completion of the two years of the study.

Official Title

Conditions

Allergy

Study Type

Interventional

Study Design

Treatment, Non-Randomised, Open Label, Active Control, Single Group Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

A negative double-blind placebo controlled food challenge at the completion the two years of the study.

Secondary Outcome Measures:

A change in the cytokine level between the baseline and each selected time point during the two years of the study.

Study Start

April 2006

Eligibility & Criteria

Eligibility

Ages Eligible for Study: 6 years to 35 years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Subjects between 6 and 35 years of age
Diagnosed with peanut allergy by positive prick skin test, CAP FEIA of 15 Ku/L or greater
History of significant clinical symptoms within one hour after ingestion of peanuts
Family’s compliance with all study visits

Exclusion Criteria: