Oral Immunotherapy for Childhood Egg Allergy

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Consortium of Food Allergy Research

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00461097

First received: April 16, 2007

Last updated: July 19, 2012

Last verified: May 2012

History of Changes

Results First Received: December 29, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Hypersensitivity Immediate Hypersensitivity Food Hypersensitivity
Interventions:	Drug: Egg oral immunotherapy Drug: Control Group

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place at five university-based medical centers in the United States (Mt. Sinai School of Medicine, Johns Hopkins University, Duke University, National Jewish Medical Center, University of Arkansas Children's Hospital) from July 2007 to December 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

Description

Egg Oral Immunotherapy (OIT)

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.

Placebo

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.

Participant Flow: Overall Study

	Egg Oral Immunotherapy (OIT)	Placebo
STARTED	40	15
Had Month 10 (Wk 44) Oral Food Challenge	35	13
Had Month 22 (Wk 96) Oral Food Challenge	34	1
COMPLETED	40 ^[1]	15 ^[1]
NOT COMPLETED	0	0

[1]	Completed: Participants who were assessed for the primary outcome measure.

Baseline Characteristics

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Reporting Groups

	Description
Egg Oral Immunotherapy (OIT)	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.
Placebo	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.
Total	Total of all reporting groups

Baseline Measures

	Egg Oral Immunotherapy (OIT)	Placebo	Total
Number of Participants [units: participants]	40	15	55
Age [units: participants]
<=18 years	40	15	55
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	7.1 ± 1.6	7.1 ± 1.6	7.1 ± 1.6
Gender [units: participants]
Female	15	6	21
Male	25	9	34
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	2	1	3
Not Hispanic or Latino	38	14	52
Unknown or Not Reported	0	0	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0
Asian	5	0	5
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	1	2
White	34	14	48
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Region of Enrollment [units: participants]
United States	40	15	55
Atopic Dermatitis Total Score ^[1] [units: Scores on a scale] Mean ± Standard Deviation	3.1 ± 2.5	3.0 ± 2.8	3.1 ± 2.5
Total IgE ^[2] [units: kU/L] Mean ± Standard Deviation	1378.7 ± 1728.6	1464.7 ± 1182.7	1402.1 ± 1588.1
Egg IgE ^[3] [units: kUA/L] Mean ± Standard Deviation	32.9 ± 54.7	32.1 ± 27.3	32.7 ± 48.5
Egg Skin Prick Test Score ^[4] [units: mm] Mean ± Standard Deviation	11.8 ± 5.7	12.8 ± 4.3	12.1 ± 5.4
Age at Initial Egg Allergic Reaction [units: years] Mean ± Standard Deviation	2.3 ± 2.1	1.3 ± 1.4	2.0 ± 2.0

[1]	The Atopic Dermatitis Total Score is scored on a 10 point scale from 0 to 9 where a higher score indicates increased severity of atopic dermatitis. This score is a combination of 3 scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity.
[2]	Total amount of serum immunoglobulin E. Individuals who are not allergic may have a total IgE as high as 304 kU/L.
[3]	Amount of serum egg-specific immunoglobulin E. Individuals with an egg IgE of <0.35 kUA/L are considered not to be sensitized to egg.
[4]	This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the egg wheal (in mm) observed for a skin prick test. Individuals with an egg skin prick test score of < 3 mm are considered to have a negative result.

Outcome Measures

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1. Primary:

Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg [ Time Frame: At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy ]

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2. Secondary:

Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid [ Time Frame: Following the blinded desensitization phase at approximately Week 44 ]

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Measure Type	Secondary
Measure Title	Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid
Measure Description	Desensitization assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were counted as successes.
Time Frame	Following the blinded desensitization phase at approximately Week 44
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.

Reporting Groups

Description

Egg Oral Immunotherapy (OIT)

Placebo

Measured Values

	Egg Oral Immunotherapy (OIT)	Placebo
Number of Participants Analyzed [units: participants]	40	15
Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid [units: percentage of participants]	55.0	0.0

No statistical analysis provided for Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid

3. Secondary:

Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation [ Time Frame: Initial day of dosing ]

Show Outcome Measure 3

4. Secondary:

Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg [ Time Frame: Following the blinded desensitization phase at approximately Week 44 ]

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5. Secondary:

Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Baseline through the 2-year primary endpoint ]

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6. Secondary:

Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consume 10,000 mg of Egg White Solid [ Time Frame: 4 years ]

Results not yet posted. Anticipated Posting Date: 12/2013 Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Associate Director, Clinical Research Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsgov@niaid.nih.gov

Publications:

Baral VR, Hourihane JO. Food allergy in children. Postgrad Med J. 2005 Nov;81(961):693-701. Review.

Sicherer SH, Sampson HA. 9. Food allergy. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S470-5. Review.

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

Publications automatically indexed to this study:

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.

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00461097 History of Changes
Other Study ID Numbers:	DAIT COFAR 3, COFAR, U19AI066738
Study First Received:	April 16, 2007
Results First Received:	December 29, 2011
Last Updated:	July 19, 2012
Health Authority:	United States: Food and Drug Administration

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