A Phase 2 interventional study of Egg oral immunotherapy and Control Group in Hypersensitivity, Immediate Hypersensitivity and Food Hypersensitivity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 5 sites in United States. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-12-13.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
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.
In the United States, as many as 6% to 8% of children are affected by food allergy. In young children, allergic reactions to egg can range from mild rash to systemic anaphylaxis. The usual standard of care for allergy is complete avoidance of this food allergen and treatment of accidental systemic reactions by access to self-injected epinephrine. 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 standard injection (under the skin) immunotherapy for food allergy is associated with a high rate of allergic reactions, a few studies have recently tried oral immunotherapy (OIT) in food allergy. The purpose of this study is to determine the safety and efficacy of the administration of OIT. The intent is to develop desensitization and eventually tolerance to egg allergen. This study will evaluate tolerance to egg white solid that may be gained by gradually increasing the amounts of egg white solid given to a child over a long period of time.
This study will last up to 48 months. The participants will be randomly assigned to receive oral immunotherapy treatment with egg white solid or placebo. This study will include dose escalation and maintenance followed by oral food challenge (OFC).
For participants receiving egg OIT, visit 1 consists of multiple small incremental doses of egg white solid. This is followed by 32-40 weeks of gradual dose escalation to a stable maintenance dose of egg white solid for at least 8 weeks. At approximately Week 44, participants are given an OFC using 5 grams of egg white solid to identify desensitized individuals. Participants and study staff are unblinded following this initial OFC. Maintenance egg OIT therapy is continued for an additional 1-3 years. Oral Food Challenges with 10 grams of egg white solid will be performed for participants on maintenance egg OIT at subsequent time points (approximately Week 96 and annually thereafter) to test for desensitization. If passed, a repeat OFC after being off therapy for 4-6 weeks will be performed to test for tolerance. An OFC to test for tolerance will use 10 grams of egg white solid and be followed by an open feeding of egg.
Participants receiving placebo during dose escalation and maintenance are given an OFC using 5 grams of egg white solid to test for desensitization at approximately 44 weeks. They are unblinded at that time, continue on an egg-restricted diet, and are followed until up to 2 years. These participants will only receive an OFC at a subsequent time point if their egg Immunoglobulin E (IgE) declines to be less than 2 kilounits of antibody per liter; this OFC will use 10 grams of egg white solid and be followed by an open feeding of egg.
At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.
38 studies on the registry are indexed under Egg Hypersensitivity; 9 are open to participants now.
This study's enrollment of 55 is below the median of 73 across 27 interventional studies indexed under Egg Hypersensitivity.
Browse Egg Hypersensitivity studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Compared within Egg Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A drug or device being studied in a clinical trial.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
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Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Investigational drug or device
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Egg white solid powder
Placebo for egg white solid
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.
Time frame: At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy
Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid
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
Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation
On the initial day of dosing, participants were offered 0.1 mg of egg white solid or placebo followed by an approximate doubling every 30 minutes up to a 50 mg dose providing limiting reactions do not occur.
Time frame: Initial day of dosing
Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg
For participants whose maximum tolerated dose on the initial escalation day was less than 50 mg, doses were doubled every 2 weeks up to 50 mg. After 50 mg, dosing was increased to 75 mg, and then dosing increased by 25% until the 2000 mg dose was reached. The maximum time allowed for the build-up phase was 40 weeks; the dose achieved at 40 weeks was considered the maintenance dose.
Time frame: Following the blinded desensitization phase at approximately Week 44
Number of Participants With Serious Adverse Events (SAEs)
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
Time frame: 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
Tolerance Assessment: Participants in the Egg OIT treatment arm who were not tolerant at 2 years were offered an additional 2 years of therapy. A 10,000 mg double-blind placebo controlled oral food challenge to egg was done the same way as the one performed at 2 years for these participants in order to identify tolerant individuals in the 2 to 4 year extension segment. The tolerant individuals from this segment were then added to the tolerant individuals from the 2 year segment.
Time frame: 4 years (48 months)
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.
| Milestone | 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 |
| Had year 3 (mnth 36) oral food challenge | 16 | 0 |
| Had year 4 (mnth 48) oral food challenge | 7 | 0 |
| Completed | 40 | 15 |
| Not completed | 0 | 0 |
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.
| percentage of participants | Egg Oral Immunotherapy (OIT) | Placebo |
|---|---|---|
| Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg | 27.5 | 0 |
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.
| percentage of participants | Egg Oral Immunotherapy (OIT) | Placebo |
|---|---|---|
| Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid | 55.0 | 0.0 |
On the initial day of dosing, participants were offered 0.1 mg of egg white solid or placebo followed by an approximate doubling every 30 minutes up to a 50 mg dose providing limiting reactions do not occur.
| percentage of participants | Egg Oral Immunotherapy (OIT) | Placebo |
|---|---|---|
| Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation | 22.5 | 86.7 |
For participants whose maximum tolerated dose on the initial escalation day was less than 50 mg, doses were doubled every 2 weeks up to 50 mg. After 50 mg, dosing was increased to 75 mg, and then dosing increased by 25% until the 2000 mg dose was reached. The maximum time allowed for the build-up phase was 40 weeks; the dose achieved at 40 weeks was considered the maintenance dose.
| percentage of participants | Egg Oral Immunotherapy (OIT) | Placebo |
|---|---|---|
| Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg | 45.0 | 80.0 |
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
| participants | Egg Oral Immunotherapy (OIT) | Placebo |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 3 | 0 |
Tolerance Assessment: Participants in the Egg OIT treatment arm who were not tolerant at 2 years were offered an additional 2 years of therapy. A 10,000 mg double-blind placebo controlled oral food challenge to egg was done the same way as the one performed at 2 years for these participants in order to identify tolerant individuals in the 2 to 4 year extension segment. The tolerant individuals from this segment were then added to the tolerant individuals from the 2 year segment.
| percentage of participants | Egg Oral Immunotherapy (OIT) |
|---|---|
| Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid | 52.5 |
Collected over Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Egg Oral Immunotherapy (OIT), 0-2 Years | — | 3/40 (7.5%) | 40/40 (100%) |
| Placebo, 0-2 Years | — | 0/15 (0%) | 15/15 (100%) |
| Egg Oral Immunotherapy (OIT), 2-4 Years | — | 1/36 (2.8%) | 26/36 (72.2%) |
| Event | Egg Oral Immunotherapy (OIT), 0-2 Years | Placebo, 0-2 Years | Egg Oral Immunotherapy (OIT), 2-4 Years |
|---|---|---|---|
| Streptococcal bacteraemiaInfections and infestations | 0/40 | 0/15 | 1/36 |
| Anaphylactic reactionImmune system disorders | 1/40 | 0/15 | 0/36 |
| Respiratory tract infectionInfections and infestations | 1/40 | 0/15 | 0/36 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/40 | 0/15 | 0/36 |
| Event | Egg Oral Immunotherapy (OIT), 0-2 Years | Placebo, 0-2 Years | Egg Oral Immunotherapy (OIT), 2-4 Years |
|---|---|---|---|
| Abdominal discomfortGastrointestinal disorders | 34/40 | 4/15 | 4/22 |
| Oral disorderGastrointestinal disorders | 31/40 | 3/15 | 8/22 |
| VomitingGastrointestinal disorders | 28/40 | 2/15 | 4/22 |
| PruritusSkin and subcutaneous tissue disorders | 28/40 | 3/15 | 4/22 |
| UrticariaSkin and subcutaneous tissue disorders | 27/40 | 5/15 | 5/22 |
| CoughRespiratory, thoracic and mediastinal disorders | 26/40 | 5/15 | 3/22 |
| Upper respiratory tract infectionInfections and infestations | 20/40 | 9/15 | 10/36 |
| Oropharyngeal discomfortRespiratory, thoracic and mediastinal disorders | 22/40 | 1/15 | 4/22 |
| SneezingRespiratory, thoracic and mediastinal disorders | 21/40 | 6/15 | 1/22 |
| FlushingVascular disorders | 18/40 | 3/15 | 2/22 |
| Age, Categorical(Participants) | Egg Oral Immunotherapy (OIT) | Placebo | Total |
|---|---|---|---|
| <=18 years | 40 | 15 | 55 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Egg Oral Immunotherapy (OIT) | Placebo | Total |
|---|---|---|---|
| Mean | 7.1 ± 1.6 | 7.1 ± 1.6 | 7.1 ± 1.6 |
| Sex: Female, Male(Participants) | Egg Oral Immunotherapy (OIT) | Placebo | Total |
|---|---|---|---|
| Female | 15 | 6 | 21 |
| Male | 25 | 9 | 34 |
| Ethnicity (NIH/OMB)(Participants) | Egg Oral Immunotherapy (OIT) | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 38 | 14 | 52 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Egg Oral Immunotherapy (OIT) | Placebo | Total |
|---|---|---|---|
| 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(participants) | Egg Oral Immunotherapy (OIT) | Placebo | Total |
|---|---|---|---|
| United States | 40 | 15 | 55 |
| Atopic Dermatitis Total Score(Scores on a scale) | Egg Oral Immunotherapy (OIT) | Placebo | Total |
|---|---|---|---|
| Mean | 3.1 ± 2.5 | 3.0 ± 2.8 | 3.1 ± 2.5 |
| Total IgE(kU/L) | Egg Oral Immunotherapy (OIT) | Placebo | Total |
|---|---|---|---|
| Mean | 1378.7 ± 1728.6 | 1464.7 ± 1182.7 | 1402.1 ± 1588.1 |
3 further baseline measures are reported on the registry.
Plan to share: Yes — Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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