Conditions: Food Hypersensitivity
Keywords: Peanut Allergy Sublingual immunotherapy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 60
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study. arm 2: Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study. arm 3: After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study. arm 4: Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort. arm 5: Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.

Interventions: intervention 1: Peanut SLIT intervention 2: Placebo SLIT
Intervention descriptions: intervention 1: Liquid peanut protein drops diluted in glycerin which are dosed under the tongue. intervention 2: Liquid glycerin without peanut which are dosed under the tongue.

Protocol document: