Oral Immunotherapy for Childhood Egg Allergy

NCT00461097 | Completed Phase 2 Results DMC

• 3 other identifiers: DAIT CoFAR3COFARU19AI066738
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to determine if oral immunotherapy (OIT) will desensitize a child with an allergy to egg and eventually lead to the development of tolerance to egg.

Conditions

Hypersensitivity; Immediate Hypersensitivity; Food Hypersensitivity

Keywords

Egg Allergy; Egg Oral Immunotherapy (OIT); Food Allergy

Outcome Measures

Primary Outcomes (1)

• Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg

  Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were then given an open feeding of egg and those who successfully consumed the open feeding of egg were counted as successes.

  At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy

Secondary Outcomes (5)

• Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid

  Following the blinded desensitization phase at approximately Week 44

• Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation

  Initial day of dosing

• Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg

  Following the blinded desensitization phase at approximately Week 44

• Number of Participants With Serious Adverse Events (SAEs)

  Baseline through the 2-year primary endpoint

• Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid

  4 years (48 months)

Study Arms (2)

Egg Oral Immunotherapy (OIT)

EXPERIMENTAL

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.

Drug: Egg oral immunotherapy

Control Group

PLACEBO COMPARATOR

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.

Drug: Control Group

Interventions

Egg oral immunotherapy DRUG

Egg white solid powder

Egg Oral Immunotherapy (OIT)

Control Group DRUG

Placebo for egg white solid

Control Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Consortium of Food Allergy Research: collaborator

Study Sites (5)

University of Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of North Carolina

Chapel Hills, North Carolina, 27599, United States

Location

Related Publications (5)

• Baral VR, Hourihane JO. Food allergy in children. Postgrad Med J. 2005 Nov;81(961):693-701. doi: 10.1136/pgmj.2004.030288.

  PMID: 16272231 BACKGROUND

• Sicherer SH, Sampson HA. 9. Food allergy. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S470-5. doi: 10.1016/j.jaci.2005.05.048.

  PMID: 16455349 BACKGROUND

• Wood RA. The natural history of food allergy. Pediatrics. 2003 Jun;111(6 Pt 3):1631-7.

  PMID: 12777603 BACKGROUND

• Burks AW, Jones SM, Wood RA, Fleischer DM, Sicherer SH, Lindblad RW, Stablein D, Henning AK, Vickery BP, Liu AH, Scurlock AM, Shreffler WG, Plaut M, Sampson HA; Consortium of Food Allergy Research (CoFAR). Oral immunotherapy for treatment of egg allergy in children. N Engl J Med. 2012 Jul 19;367(3):233-43. doi: 10.1056/NEJMoa1200435.

  PMID: 22808958 RESULT

• Jones SM, Burks AW, Keet C, Vickery BP, Scurlock AM, Wood RA, Liu AH, Sicherer SH, Henning AK, Lindblad RW, Dawson P, Berin C, Fleischer DM, Leung DYM, Plaut M, Sampson HA; Consortium of Food Allergy Research (CoFAR). Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy. J Allergy Clin Immunol. 2016 Apr;137(4):1117-1127.e10. doi: 10.1016/j.jaci.2015.12.1316. Epub 2016 Mar 9.

  PMID: 26924470 DERIVED

MeSH Terms

Conditions

Hypersensitivity; Hypersensitivity, Immediate; Food Hypersensitivity; Egg Hypersensitivity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Associate Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsgov@niaid.nih.gov

301-594-7669

Study Officials

• Wesley Burks, MD

  University of North Carolina

  STUDY CHAIR

• Stacie Jones, MD

  Allergy/Immunology Department, Arkansas Children's Hospital

  STUDY CHAIR

• Robert Wood, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Scott Sicherer, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• David Fleischer, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 17, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2013
• Last Updated: December 13, 2017
• Results First Posted: May 1, 2012

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

US (5)