Oral Immunotherapy for Childhood Egg Allergy
Hypersensitivity, Immediate Hypersensitivity, Food Hypersensitivity
About this trial
This is an interventional treatment trial for Hypersensitivity focused on measuring Egg Allergy, Egg Oral Immunotherapy (OIT), Food Allergy
Eligibility Criteria
Inclusion Criteria:
- Convincing clinical history of egg allergy
- Age 6 to 18 years, with a serum IgE [UniCAP] to egg > 5 kUA/L OR
- Age 5 to 6 years, with a serum IgE [UniCAP] to egg ≥ 12kUA/L
- Parent/guardian willing to provide informed consent
- Willing to use acceptable forms of contraception
Exclusion Criteria:
- History of severe anaphylaxis to egg. More information on this criterion can be found in the protocol.
- Known allergy to corn
- Chronic disease requiring therapy (e.g., heart disease, diabetes). Participants who have asthma, atopic dermatitis, or rhinitis are not excluded.
- Participation in any interventional study for the treatment of food allergy in the 6 months prior to study entry
- Participant is on "build-up phase" of immunotherapy and has not reached maintenance dosing. Participants tolerating maintenance allergen immunotherapy are not excluded.
- Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.
- Inability to discontinue antihistamines for the initial day of escalation, skin testing, and OFC
- Omalizumab or other nontraditional forms of oral or sublingual allergen immunotherapy, immunomodulator therapy, or biologic therapy in the 12 months prior to study entry. Participants who have taken corticosteroids are not excluded.
- Investigational drugs 90 days prior to study entry or planned use of an investigational drug during the study period
- Pregnancy or breastfeeding
Sites / Locations
- University of Arkansas Children's Hospital Research Institute
- National Jewish Medical and Research Center
- Johns Hopkins University School of Medicine
- Mount Sinai School of Medicine
- University of North Carolina
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Egg Oral Immunotherapy (OIT)
Control Group
Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.