Evaluation of Potential Allergenicity of New Soybean Varieties

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