Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy

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.

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