• Percent of participants who consume without symptoms 5,000 mg of egg white solid [ Time Frame: Following the desensitization phase of the study ] [ Designated as safety issue: No ]
• Percent of participants who successfully complete the initial escalation to 50 mg of egg white solid OIT [ Time Frame: During the first 32 weeks of the study ] [ Designated as safety issue: No ]
• Percent of participants who achieve the 2,000 mg dose of egg white solid OIT [ Time Frame: During the desensitization phase of the study ] [ Designated as safety issue: No ]
• Incidence of all serious adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

• Percent of participants who consume without symptoms 5,000 mg of egg white solid following the desensitization phase of the study
• percent of participants who successfully complete the initial escalation to 50 mg of egg white solid OIT
• percent of participants who achieve the 2,000 mg dose of egg white solid OIT during the desensitization phase of the study
• incidence of all serious adverse events

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 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 22 months. The participants will be randomly assigned to receive treatment with egg white solid or placebo. This study will include dose escalation followed by oral food challenge (OFC). Visit 1 consists of multiple small incremental doses of egg white solid. This is followed by 32 weeks of gradual dose escalation to a stable maintenance dose of egg white solid. Around Week 40, participants will be given an OFC using egg white solid to identify desensitized individuals. Participants and study staff will be unblinded following this initial OFC. Maintenance therapy is continued for an additional year. An end of study OFC challenge will be performed to test for desensitization. If passed, a repeat OFC off therapy will be performed to test for tolerance.

Participants receiving placebo during dose escalation are given the OFC at 40 weeks. They will be unblinded at that time and continue on an egg-restricted diet until the end of the study.

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

• Hypersensitivity
• Immediate Hypersensitivity
• Food Hypersensitivity

• Drug: Oral egg immunotherapy
• Drug: Placebo for egg white solid

• Experimental: Oral egg immunotherapy (in the form of egg white solid) and up to four oral food challenges as directed by the protocol
• Placebo Comparator: Placebo for egg white solid and up to four oral food challenges as directed by the protocol

• 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.

Inclusion Criteria:

• Convincing clinical history of egg allergy
• Serum IgE [UniCAP] to egg of greater than 5 kU/l
• Parent/guardian willing to provide informed consent
• Willing to use acceptable forms of contraception
• Age 5 to 6 years, with a serum IgE [UniCAP] 12kU/L

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 12 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