A Study of Sublingual Immunotherapy in Peanut-allergic Children (SLB)

University of North Carolina (UNC)

Status and phase: Completed; Phase 2

Conditions: Food Hypersensitivity

Treatments: Drug: Placebo SLIT; Drug: Peanut SLIT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00597727

11-2296

5R01AT004435-09 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 5 patient groups, including a placebo group

Blinded Peanut SLIT

Active Comparator group

Description:

Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.

Treatment:

Drug: Peanut SLIT

Blinded Placebo SLIT

Placebo Comparator group

Description:

Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.

Treatment:

Drug: Placebo SLIT

Ext. maint. open label peanut SLIT

Other group

Description:

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.

Treatment:

Drug: Peanut SLIT

Early unblinded peanut SLIT

Other group

Description:

Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.

Treatment:

Drug: Peanut SLIT

Pilot peanut SLIT rollover cohort

Other group

Description:

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.

Treatment:

Drug: Peanut SLIT