Efficacy and Safety Assessment of Beltavac® With Polymeri... | NCT05395689

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active substance	Experimental	House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae solution administered by the subcutaneous route for 12 months using a rush schedule	Biological: House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae
Placebo	Placebo Comparator	Saline solution administered by the subcutaneous route for 12 months using a rush schedule	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae	Biological	The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The combined nasal symptom and medication score	The symptoms assessed are: itchy nose, sneezing, runny nose, and blocked nose (all rated from 0-3). The medication score is 1 for oral and/or topical antihistamines, 2 for intranasal corticosteroids, and 3 for oral corticosteroids. The scores from the nasal symptoms are added and divided by 4 to a total daily symptom score from 0-3.Final score range from 0 to 6, higher score meaning a worse outcome.	12 months of treatment

Secondary Outcomes

Measure	Description	Time Frame
Score of the nasal symptoms scale	Symptoms assessed are: itchy nose, sneezing, runny nose, and blocked nose (all rated from 0-3). Final score range from 0 to 3, higher score meaning worse outcome.	12 months of treatment
Score of the specific medication scale

Eligibility Module

Eligibility Criteria

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.

ID	Term
D012221	Rhinitis, Allergic, Perennial
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D010038	Otorhinolaryngologic Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D000941	Antigens
D001685	Biological Factors