SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding

Inclusion Criteria: * Signed informed consent * Age ≥ 18 ≤ 60 years * Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma * FEV1 \> 70% for patients with a history of asthma, FEV \> 70% or PEF \> 80% for patients without a history of asthma * A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen assessed within 1 year before randomization. * Positive serum specific anti-birch IgE-test (\> 0.7 U/mL) * A positive TNPT for birch pollen at screening (Lebel score ≥ 6) at * 10,000 AU/mL Exclusion Criteria: * Patients with (expected) clinically relevant symptoms during the course of the trial due to concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3mm) to allergens other than birch pollen * Patients sensitized to pets should not be included if they are regularly exposed to pets and are symptomatic upon exposure to pets * Completed immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years * Completed unsuccessful specific immunotherapy in the past * Vaccination within one week before start of therapy or during the initiation phase * Anti-IgE therapy within the 6 months prior to inclusion and during the study * Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs * Active malignancies or any malignant disease during the previous 5 years * Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders * Active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study * Moderate to severe nasal obstructive diseases that preclude a TNPT (septal deviation, nasal polyps, recent nasal surgery, etc.) * Diseases with a contraindication for the use of Adrenaline (e.g. hyperthyroidism, glaucoma) * Use of systemic steroids within 4 weeks before start of the study and during the study * Treatment with systemic and local β-blockers * Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study * Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be the use of a contraceptive device or -pill) * Alcohol, drug or medication abuse within the past year * Any clinically significant abnormal laboratory parameter at screening * Lack of cooperation or compliance * Severe psychiatric, psychological, or neurological disorders * Patients who are employees of the institution or 1st grade relatives or partners of the investigator