Evaluation of Potential Allergenicity of New Soybean Varieties

Inclusion Criteria:

- Age 6 months to 40 years of any sex and any race

- A convincing history of allergic reaction to soybean and a positive ImmunoCAP (>0.35
kU/L) and/or a positive skin prick test to soy. Subjects should have ImmunoCAP
repeated (if not done within the last 6 months) at National Jewish Health.

- One of the following:

A) Recent (within one year) failed open OFC B) Positive DBPCFC to soy at NJH; or C) Recent
(within one year) exposure to soybean resulting in immediate IgE-mediated allergic symptoms
(within 2 hours of ingestion; symptoms such as urticaria, angioedema, congestion,
rhinorrhea, wheezing).

- Written informed consent from parent/guardian and assent (when age appropriate).

- Willingness to submit specimen for laboratory serum IgE testing

- Willingness to submit lab specimen for ELISA testing

Exclusion Criteria:

- Inability to discontinue antihistamines for skin prick testing and OFCs

- Current allergy to placebo ingredient (oat flour) OR reaction to any dose of placebo
at the qualifying OFC

- FEV1 value <80% predicted or any clinical features of moderate or severe persistent
asthma, as defined by the 2007 NHLBI guidelines table for classifying asthma severity
(Step 3 or above), and greater than high daily doses of inhaled corticosteroids, as
defined by the 2007 NHLBI guidelines inhaled corticosteroid dosing table (500 μg
fluticasone or equivalents for an adult)

- Asthma requiring either:

> 1 hospitalization in the past year for asthma or > 1 ER visit in the past 6 months for
asthma

- History of intubation due to allergies or asthma

- Life-threatening allergic reaction (i.e. respiratory compromise, hypoxia, hypotension)
to food(s) within last 1 year

- Diagnosis of active eosinophilic gastrointestinal disease in the past year

- Severe or poorly controlled atopic dermatitis

- Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral
or sublingual), immunomodulatory therapy (not including corticosteroids), or biologic
therapy within the past year

- Uncontrolled hypertension

- Any use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors,
angiotensin-receptor blockers (ARB) or calcium channel blockers

- Other significant medical conditions (e.g., liver, gastrointestinal, kidney,
cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the
Investigator, make the subject unsuitable for induction of food reactions

- Pregnancy