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

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 theARIA Guide, associated or not with well or partially controlled asthma according tothe GEMA 5.0 Guide.

• Confirmation of sensitization to DPT or DF with a positive prick test (mean papulediameter greater than or equal to 3 mm) with a commercial standardized allergenicextract 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 relevantsymptoms are anticipated that may interfere with study evaluation periods at thediscretion 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 theirasthma 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 otherrelevant 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 ofpatients and until the end of the study.

• Treatment with beta-blockers during the study.

• Patients who have previously received immunotherapy with allergenic dust miteextract or other extracts and have failed within the last 5 years.

• Patients with immunotherapy with allergens other than dust mites during the studyperiod.

• Patients who receive any other vaccine one week before the start of treatment orawaiting the second dose of vaccine against COVID-19.

• Pregnant or nursing patients.