A Study of Sublingual Immunotherapy in Peanut-allergic Children

Food Hypersensitivity Clinical Trial

— SLB  

Official title:

A Double-blinded, Placebo-controlled Study of Peanut Sublingual Immunotherapy in Children - DBPC Peanut SLIT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597727
• Other study ID #: 11-2296
• Secondary ID: 5R01AT004435-09
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2008
• Last updated: February 27, 2018
• Start date: January 2008
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• Peanut SLIT
Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.
• Placebo SLIT
Liquid glycerin without peanut which are dosed under the tongue.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chin SJ, Vickery BP, Kulis MD, Kim EH, Varshney P, Steele P, Kamilaris J, Hiegel AM, Carlisle SK, Smith PB, Scurlock AM, Jones SM, Burks AW. Sublingual versus oral immunotherapy for peanut-allergic children: a retrospective comparison. J Allergy Clin Immunol. 2013 Aug;132(2):476-8.e2. doi: 10.1016/j.jaci.2013.02.017. Epub 2013 Mar 25. — View Citation

Kim EH, Bird JA, Kulis M, Laubach S, Pons L, Shreffler W, Steele P, Kamilaris J, Vickery B, Burks AW. Sublingual immunotherapy for peanut allergy: clinical and immunologic evidence of desensitization. J Allergy Clin Immunol. 2011 Mar;127(3):640-6.e1. doi: — View Citation

Kulis M, Saba K, Kim EH, Bird JA, Kamilaris N, Vickery BP, Staats H, Burks AW. Increased peanut-specific IgA levels in saliva correlate with food challenge outcomes after peanut sublingual immunotherapy. J Allergy Clin Immunol. 2012 Apr;129(4):1159-62. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing	Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 months of peanut SLIT therapy.	12 months
Secondary	Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing	Upon completion of 36-60 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. Peanut SLIT therapy was then discontinued for 2-4 weeks to assess for persistence of the desensitization response called sustained unresponsiveness (SU). The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5000 mg peanut protein DBPCFC without developing symptoms 2-4 weeks after discontinuing peanut SLIT therapy.	36-60 months