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.
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 designed to evaluate the efficacy
and safety of peanut SLIT compared to placebo after 12 months. Mechanistic studies will be
completed concurrently to understand changes in the allergic immune response related to
peanut SLIT. The remainder of the study is designed to evaluate the efficacy of peanut SLIT
in inducing lasting tolerance after discontinuation of the peanut SLIT.
- 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
- 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