Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM

Efficacy and Safety Assessment of a Subcutaneous Immunotherapy (Beltavac®) With Polymerized Allergenic Extract From House Dust Mites in Patients With Allergic Rhinitis/Rhinoconjuntivitis

The trial is performed to assess efficacy and safety of Beltavac with polymerized extract of house dust mites in allergic Rhinoconjunctivitis associated or not with asthma

Inclusion Criteria:

• Written informed consent, signed and duly dated.
• Man or woman between 12 and 65 years old (both included).
• Patient with moderate or severe symptoms of persistent rhinitis according to the ARIA Guide, associated or not with well or partially controlled asthma according to the GEMA 5.0 Guide.
• Confirmation of sensitization to DPT or DF with a positive prick test (mean papule diameter greater than or equal to 3 mm) with a commercial standardized allergenic extract and a serum extract-specific IgE value of class 3 or higher (> 3.5 kU / L) within the 6 months prior to the study.
• Negative pregnancy test.
• Nasal symptom and medication combined scale score ≥ 1.5 during the screening phase.

Exclusion Criteria:

• Concomitant sensitization to allergens other than dust mites if clinically relevant symptoms are anticipated that may interfere with study evaluation periods at the discretion of the investigator.
• Poorly controlled asthma according to the GEMA 5.0 guideline
• Severe asthma, that is, those who during the last months have controlled their asthma according to therapeutic step 5-6 of the GEMA 5.0 guideline.
• Autoimmune diseases or immunodeficiency.
• Malignant neoplasms, serious cardiovascular disease, serious mental illness or other relevant chronic diseases that may interfere with the results of the study.
• Clinical history of anaphylaxis with cardio / respiratory symptoms.
• Hypersensitivity to any of the excipients of the investigational product.
• Immunosuppressive medication during the last 6 months before the inclusion of patients and until the end of the study.
• Treatment with beta-blockers during the study.
• Patients who have previously received immunotherapy with allergenic dust mite extract or other extracts and have failed within the last 5 years.
• Patients with immunotherapy with allergens other than dust mites during the study period.
• Patients who receive any other vaccine one week before the start of treatment or awaiting the second dose of vaccine against COVID-19.
• Pregnant or nursing patients.