Overview

This trial is active, not recruiting.

Conditions peanut hypersensitivity, food hypersensitivity, food allergy, peanut allergy
Treatments liquid peanut extract (peanut slit), placebo glycerin slit
Phase phase 1/phase 2
Sponsor University of North Carolina, Chapel Hill
Collaborator National Institute of Allergy and Infectious Diseases (NIAID)
Start date June 2011
End date January 2017
Trial size 50 participants
Trial identifier NCT01373242, 11-2308, 1R01AT004435-01

Summary

The goal of this study will be to increase the reaction threshold (desensitization) of peanut allergic children using peanut sublingual immunotherapy and to determine if the nonreactive state of the immune system persists after treatment has been discontinued (tolerance).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
All subjects will receive peanut SLIT upon enrollment for the first 48 months. After the desensitization DBPCFC at 48 months, subjects will be randomized 2:1 to placebo or continued peanut SLIT. The SLIT group will complete 60 months of SLIT prior to undergoing a final DBPCFC at 66 months to assess clinical tolerance.
liquid peanut extract (peanut slit) Peanut SLIT - active arm
Liquid peanut extract will be administered under the tongue
(Placebo Comparator)
All subjects will receive peanut SLIT for 48 months upon enrollment. After the desensitization DBPCFC at 48 months, subjects will be randomized 2:1 to placebo or continued peanut SLIT for 6 months and then undergo a DBPCFC to assess clinical tolerance. The placebo subjects will either demonstrate tolerance or be eligible to restart SLIT for the remainder of the study if they fail to achieve tolerance.
placebo glycerin slit Placebo Glycerin SLIT
Liquid glycerin extract will be administered under the tongue

Primary Outcomes

Measure
Percentage of subjects on placebo vs peanut SLIT who pass the 54 month double blind, placebo controlled food challenge to assess tolerance.
time frame: 54 months

Secondary Outcomes

Measure
Percentage of subjects who demonstrate clinical desensitization by passing the 48 month double-blind, placebo-controlled food challenge.
time frame: 48 months
Induction of clinical tolerance after 48months vs 60 months of peanut SLIT.
time frame: 66 months
The change in immune parameters over time associated with the induction of tolerance.
time frame: 66 months
The change of immune function of those who achieve tolerance versus those who do not achieve tolerance.
time frame: 66 months

Eligibility Criteria

Male or female participants from 1 year up to 11 years old.

Inclusion Criteria: - Age 1-11 years - Peanut specific IgE > 0.35kU/L or a convincing clinical history of an allergic reaction to peanut within 1 hour of ingestion - Positive entry DBPCFC to 1 gram of peanut protein Exclusion Criteria: - History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or oxygen saturations < 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence) - Participation in any interventional study for the treatment of food allergy in the past 6 months - Known oat, wheat, or glycerin allergy - Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease - Severe asthma (2007 National Heart Lung and Blood Institute (NHLBI) guidelines Criteria Steps 5 or 6 - Appendix 2) - Inability to discontinue antihistamines for skin testing and DBPCFCs - Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year - Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers - Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would make the subject unsuitable for induction of food reactions

Additional Information

Official title Peanut Sublingual Immunotherapy and Induction of Clinical Tolerance in Peanut Allergic Children (SLIT Tolerance TLC) {Sublingual Immunotherapy for Peanut Allergy}
Principal investigator Wesley Burks, MD
Description Allergy to peanuts and tree nuts affects approximately 1.4% of the population. Allergic reactions to peanut can be severe and life threatening and account for the vast majority of fatalities due to food-induced anaphylaxis. At present, there are no viable treatment options for patients with peanut allergy. The current standard of care is strict dietary elimination and emergency preparedness with an anaphylaxis kit in the event of an accidental reaction. Our group and others have shown that oral immunotherapy can provide protection from anaphylaxis to a variety of food proteins. In addition, our ongoing research has demonstrated that sublingual immunotherapy to peanut provides a safe, alternative mode of immunotherapy to reduce allergic reaction rates (desensitization) during oral food challenge (OFC) to peanut. The goal of this study will be to desensitize peanut allergic children using peanut sublingual immunotherapy and to determine if the nonreactive state of the immune system persists after treatment has been discontinued (tolerance). Children ages 1-11 years will be enrolled following an entry double blind, placebo controlled food challenge (DBPCFC). All children will receive peanut sublingual immunotherapy (SLIT) for 48 months and before undergoing a second DBPCFC. Subjects who demonstrate desensitization at this food challenge will be randomized to placebo or continued peanut SLIT for 6 months prior to undergoing a third DBPCFC to assess clinical tolerance. Subjects randomized to continued peanut SLIT will complete 6 additional months of the study drug. At that point, they will discontinue SLIT for 6 months and have a final DBPCFC to assess tolerance at the end of study (66 months). Outcome variables of interest include response to double blind, placebo controlled food challenges, skin prick testing, peanut specific serum immunoglobin E (IgE), immunoglobin G (IgG), and immunoglobin G4 (IgG4) and salivary immunoglobin A (IgA), T and B cell responses, basophil hyporesponsiveness, quality of life, and adverse events.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.