The purpose of this study is to determine if a new method of administration of peanut sublingual immunotherapy, a dissolving peanut film, is effective.
Peanut allergy is a common problem with no current treatment. Recent studies have shown some success with oral or sublingual immunotherapy for the treatment of food allergy. Oral treatment, which requires very high doses, is associated with a small but appreciable risk of systemic reactions. Sublingual immunotherapy, which utilizes much smaller doses, is safer but constraints inherent in the available methods of sublingual administration have limited the utility of this method. Typically sublingual immunotherapy for food allergy has used either fresh foods or a simple liquid extract. These methods are not optimized for practicality or dwell duration in the mouth, and, thus far, dosing has been limited by the ability to make concentrated extracts and by the volume of extract that can be applied to the sublingual space. This study is being conducted to determine if a dissolving peanut extract film, will improve efficacy for immunotherapy for peanut allergy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Johns Hopkins Hospital
Baltimore, Maryland, United States
Mount Sinai School of Medicine
New York, New York, United States
The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons
No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled.
Time frame: 18 months
The Proportion of Subjects Who Are Able to Tolerate the Full 10 Gram Peanut Protein Challenge at the Completion of the Study
For peanut allergic subjects only
Time frame: 18 months
Number of Participants With Serious and Non-serious Adverse Effects With Therapy
Time frame: 18 months
The Rate of Medication Use With Therapy
For peanut allergic subjects only.
Time frame: 18 months
Changes in Biomarkers (Peanut Specific Immunoglobulin E (IgE) and Immunoglobulin G (IgG), Basophil Reactivity, and Salivary Biomarkers) From Baseline to the End of Therapy
Only in peanut allergic subjects
Time frame: 18 months
Number of Participants With Serious Adverse Events With Dosing
Time frame: 18 months
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