Birch-SPIRE Safety and Efficacy Study

Inclusion Criteria: * Male or female, aged 18 to 65 years; * Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen * Birch IgE ≥ 0.35 kU/L * Positive skin prick test to whole birch allergen Exclusion Criteria: * Any past history of asthma * FEV1 \< 80% of predicted * History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food * Acute phase skin response to whole birch allergen with a mean wheal diameter \> 50mm * Administration of adrenaline (epinephrine) is contraindicated * History of severe drug allergy or anaphylactic reaction to food. * History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)