Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
PROACAROS
1 other identifier
interventional
350
1 country
18
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2022
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2022
CompletedFirst Submitted
Initial submission to the registry
May 19, 2022
CompletedFirst Posted
Study publicly available on registry
May 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
July 18, 2024
July 1, 2024
4.4 years
May 19, 2022
July 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 (12)
Score of the nasal symptoms scale
12 months of treatment
Score of the specific medication scale
12 months of treatment.
Percentage of days without symptoms or medication
12 months of treatment
VAS score (completed by the patient and the investigator)
12 months of treatment.
RCAT questionnaire
12 months of treatment.
- +7 more secondary outcomes
Study Arms (2)
Active substance
EXPERIMENTALHouse dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae solution administered by the subcutaneous route for 12 months using a rush schedule
Placebo
PLACEBO COMPARATORSaline solution administered by the subcutaneous route for 12 months using a rush schedule
Interventions
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Hospital Vega Baja
Orihuela, Alicante, Spain
Hospital General de Granollers
Granollers, Barcelona, Spain
Hospital de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital de la Plana
Castellon, Castellón, Spain
Hospital Regional de Málaga
Málaga, Málaga, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Fundacion Sanitaria Sant Pere Claver
Barcelona, Spain
Hospital de Bellvitge
Barcelona, Spain
Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital infantil Vall d Hebron
Barcelona, Spain
Hospital Val d ' Hebron
Barcelona, Spain
Hospital General de Castellón
Castelló, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital de Fatima
Seville, Spain
Hospital Virgen Macarena
Seville, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital Politecnico de la Fé
Valencia, Spain
Hospital Universitario Infantil de la Fé
Valencia, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2022
First Posted
May 27, 2022
Study Start
January 17, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
July 18, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share