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Chapel Hill, North Carolina 27599


The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.

Study summary:

In spite of increased recognition and understanding of food allergies, food-induced anaphylaxis remains the single most common cause of anaphylaxis seen in hospital emergency departments, accounting for about one third of anaphylaxis cases seen. It is estimated that about 30,000 food-induced anaphylactic events are seen in U.S. emergency departments each year and that about 200 fatal cases occur in the U.S. each year. Either peanuts or tree nuts cause more than 80% of these reactions. No treatments are available and avoidance is the only approved intervention. The goal of this study is to investigate peanut sublingual immunotherapy (SLIT) as a treatment for children with peanut allergy. This study is primarily designed to evaluate the efficacy and safety of peanut SLIT compared to placebo after 12 months. Secondarily, the study is designed to evaluate the efficacy of extended maintenance dosing of peanut SLIT in inducing lasting tolerance after discontinuation of the peanut SLIT. Mechanistic studies will be completed concurrently as exploratory endpoints to understand changes in the allergic immune response related to peanut SLIT.


Inclusion Criteria: - Peanut IgE > 7kU/L (> 2kU/L for children aged 2 years and under) AND - History of significant clinical symptoms within 60 minutes after the ingestion of peanuts. Exclusion Criteria: - History of severe life-threatening anaphylaxis to peanut, OR - Medical history that would prevent a DBPCFC to peanut, OR - Subjects with wheat or oat allergy (which are used in the placebo), OR - Unable to cooperate with challenge procedures, OR - Unable to be reached by telephone for follow-up



Primary Contact:

Principal Investigator
Wesley Burks, MD
University of North Carolina

Backup Contact:


Location Contact:

Chapel Hill, North Carolina 27599
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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