The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy

Inclusion Criteria: * Are age 6 to 21 years * Provide signed informed consent (by parent or legal guardian if the subject is a minor), and informed assent if applicable * Have a history of symptomatic reactivity to cow's milk (i.e. Eczema, urticaria, upper or lower respiratory symptoms, GI disturbances, other rash or oral symptoms) * Have a positive skin prick test (defined as wheal 3 mm ≥ negative control) and cow's milk- immunoglobulin E (IgE) \> 0.35 kilo Immunoglobulin Units (kIU)/L * Have a positive OFC to cow's milk at a cumulative dose of less than 184 milligrams of cow's milk intact protein (2,400 mg total milk protein). * Are using appropriate birth control if subject is female and of child bearing age. * Have self-injectable epinephrine (ie. EpiPen® or EpiPen Jr.®) available at home Exclusion Criteria: * Have a history of severe anaphylaxis defined as hypoxia (cyanosis or SpO2 ≤ 92% at any stage), hypotension, confusion, collapse, loss of consciousness; or incontinence * Have a history of intubation related to asthma * Tolerate more than 184 milligrams of intact cow's milk protein at initial OFC * Are pregnant or lactating * Have a viral Upper Respiratory Infection (URI) or gastroenteritis within 7 days of OFC (OFC needs to be rescheduled) * Have pulmonary function tests \<80% of predicted (FEV1) or clinical history consistent with more than moderate persistent asthma * Are currently taking greater than medium dose inhaled corticosteroid (\>400 mcg/day fluticasone or fluticasone equivalent if ≤ 12 years old or \> 600 mcg/day if \> 12 years old) * Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges * Have used systemic corticosteroids within 4 weeks prior to baseline visit * Are receiving omalizumab, beta-blocker, Angiotensin Converting Enzyome (ACE) inhibitor or tricyclic antidepressant therapy * Have a chronic disease (other than asthma, atopic dermatitis or rhinitis) requiring therapy (e.g., heart disease, diabetes) * Have participated in any interventional study for treatment of a food allergy in the past 12 months * Have a severe reaction at initial DBPCFC, defined as either: Life-threatening anaphylaxis, or Reaction requiring hospitalization