Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy (CoFAR7)

Oral Desensitization to Egg With Subsequent Induction of Sustained Unresponsiveness for Egg-Allergic Children Using Baked Egg or Egg Oral Immunotherapy (OIT)

The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing sustained unresponsiveness to egg exposure in children.

Study Overview

• Status: Completed
• Conditions: Food Allergy
• Intervention / Treatment: Drug: Egg Oral Immunotherapy; Drug: Baked Egg

Detailed Description

Food allergy affects 6-8 percent of children in the United States. In young children, reactions to egg can range from hives to severe life threatening allergic reactions called anaphylaxis. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The purpose of this study is to compare baked foods with egg versus (vs.) egg OIT. The intent of the study is to investigate if participants will be able to consume egg after taking baked foods with egg or egg OIT for a period of time and then stopping for a certain period. This is referred to as tolerance or sustained unresponsiveness. This study will evaluate the effectiveness of the egg OIT vs. baked egg by having each participant ingest egg white solid or baked foods with egg. This will be done over 2 years.

This study will last 2 years. All eligible subjects will receive a baked egg oral food challenge (OFC). Those who pass the baked egg OFC will then have a 2 gm egg OFC. Those who react to the egg OFC will be randomized to Baked Egg or Egg OIT. Individuals who do not pass the initial baked egg OFC will be assigned to Egg OIT. Those who pass the egg OFC will not be eligible for the study and will be followed per site standard of care. All eligible and enrolled subjects will have a 1-year and a 2-year OFC.

At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • New York
    • New York, New York, United States, 100029
      • Icahn School of Medicine at Mount Sinai
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina - Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 3 through 16 years with a serum IgE to egg of >= 5 kUA/L within the past 12 months]
• Reacting to the initial baked egg OFC with dose limiting symptoms OR
• Reacting on a 2 gm egg OFC with dose limiting symptoms to a cumulative dose of 2 gm or less after passing the initial baked egg OFC
• Written informed consent from subject and/or parent/guardian
• Written assent from all subjects as appropriate
• All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

• History of anaphylaxis to egg resulting in hypotension, neurological compromise or mechanical ventilation
• Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
• Active eosinophilic gastrointestinal disease in the past 2 years
• Participation in any interventional study for the treatment of food allergy in the past 6 months
• Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.
• Severe asthma, or uncontrolled mild or moderate asthma. More information on these exclusion criteria can be found in the protocol.
• Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
• 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 (e.g. infliximab, rituximab, etc.) within the past year
• Use of Beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
• Use of investigational drug within 90 days or plan to use investigational drug during the study period
• Pregnancy or lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Egg OIT Randomized; Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.	Drug: Egg Oral Immunotherapy; Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.; Other Names: Egg white solid
Experimental: Baked Egg Randomized; Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive baked egg in the form of home-baked goods and "safe" commercial products with up to four oral food challenges as directed by the protocol.	Drug: Baked Egg; Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.
Experimental: Egg OIT Assigned; Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.	Drug: Egg Oral Immunotherapy; Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.; Other Names: Egg white solid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained Unresponsiveness to Egg Consumption at 2 Years.	Sustained unresponsiveness - able to successfully consume 7444 mg egg white protein in a desensitization OFC and, after an 8-10 week egg-free interval, were also able to successfully consume 7444 mg egg white protein in an OFC after up to 2 years of therapy.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desensitization to >= 4.444 Grams Egg White Solid.	Development of desensitization to able to successfully consume >=4444 mg egg white protein during a desensitization OFC on therapy at 1 year and 2 years.	1 Year and 2 Years
Incidence of All Serious Adverse Events	Incidence of all serious adverse events during the study. No statistical analyses were performed since there were no events in 2 of the 3 treatment groups and only 1 event in the third so it would not be meaningful.	up to 3 years
Number of Participants With Unrestricted Consumption of Unbaked Egg	Number of participants who reported consumption of concentrated (unbaked) egg in their diet on the long-term follow-up questionnaire 3 years after randomization, indicating unrestricted consumption of unbaked egg. This is a qualitative questionnaire asking participants about egg in their diet, symptoms, and what treatment they received for their allergic reactions.	3 years after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Egg-specific Mechanistic Measures and Skin Prick Test Results.	Changes in egg-specific IgE and IgG4, changes in SPT mean wheal diameters, basophil reactivity, Th2 and Treg values.	2 Years

Collaborators and Investigators

• Sponsor: Hugh A Sampson, MD
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Consortium of Food Allergy Research
• Investigators: Study Chair: Hugh A Sampson, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

Helpful Links

• Study Web Site

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): September 28, 2017
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: April 30, 2013
• First Submitted That Met QC Criteria: April 30, 2013
• First Posted (Estimate): May 3, 2013

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Food Allergy; Egg Allergy; Egg Oral Immunotherapy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: GCO 04-1271; U19AI066738 (U.S. NIH Grant/Contract); CoFAR7 (Other Identifier: Consortium of Food Allergy Research)