Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy

Exclusion Criteria

• •Asthma: GINA 2 to 5
• •Eosinophilia \> 0.6x109/mL;
• •Any history of anaphylactic reactions;
• •Specific immunotherapy treatment at the moment, including Omalizumab;
• •Specific immunotherapy for birch-pollens within 3 previous years;
• •Use of systemic corticosteroid or others immunosuppressive treatment within previous 6 months;
• •Moderate to severe allergic rhinoconjunctivitis with or without asthma due to grass pollen, if the study is performed during grass pollen season (according to ARIA)
• •Significant rhinitis, or sinusitis, due to daily contact with other allergen causing symptoms that are expected to coincide with exposures, as assessed by the investigator
• •Contraindications known to treatment with IL-2:
• •* Hypersensitivity to the active substance or to any of the excipients;
• •* Immunosuppressed patient;
• •* Psychotropic, hepatotoxic, nephrotoxic, myelotoxic or cardiotoxic drugs;
• •* Other chronic diseases not clinically controlled;
• •* Signs of active infection requiring treatment;
• •* Previous history of organ transplantation.
• •* Heart failure (≥ grade II, class. NYHA), kidney failure (Cockroft \<60 ml/min/1.73m2), liver failure (transaminase\> 3N), pulmonary insufficiency (any grade);
• •Leukocytes \<3000 / mm3 lymphocytes \<800 / mm3, platelets \<80 000 / mm3, Hemoglobin \< 10.0 g/dL or 6.2 mmol/L, red cell blood \< 3.5 T/L;
• •Positivity of at least one of the thyroid-specific antibodies (anti-TPO, anti-TG, or anti-TRAKS) associated with an abnormal thyroid workup (TSH, T3, or T4) at inclusion;
• •Chronic uncontrolled arterial hypertension (Systolic BP \> 140 mmHg and/or Diastolic BP \> 90 mmHg);
• •Poor venous capital will forbid blood samples;
• •Vaccination with attenuated live vaccine in the month before the inclusion or planned during the study;
• •Vaccination against COVID-19 during the study period or if the 2nd dose of vaccine is planned during the 15 days preceding Visit 3
• •Surgery in the previous three months or anticipated under study;
• •Participation in other interventional research with study drug in the previous month and during the study;
• •Psychiatric illness or any other concomitant chronic illness or addiction that could interfere with the ability to meet the requirements of the protocol or provide informed consent;
• •Presence or history of unhealed cancer for more than five years, presence or history of healed cancer for less than five years, except carcinoma in situ of the cervix or basal cell carcinoma;
• •Pregnant or lactating women;
• •Men and women of childbearing age without effective contraception during the treatment period;