Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
NCT ID: NCT05395689
Last Updated: 2024-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
350 participants
INTERVENTIONAL
2022-01-17
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active substance
House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae solution administered by the subcutaneous route for 12 months using a rush schedule
House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
Placebo
Saline solution administered by the subcutaneous route for 12 months using a rush schedule
Placebo
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
Interventions
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House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
Placebo
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
65 Years
ALL
No
Sponsors
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Probelte Pharma S.L.U.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Angel Ferrer
Role: primary
Patricia Martinez Lezcano, MD
Role: primary
David El Qutob, MD
Role: primary
M J Torres
Role: primary
Ana Tabar Purroy, MD
Role: primary
Helena Hermida, MD
Role: primary
Teresa Dordal, MD
Role: primary
Albert Roger, MD
Role: primary
Teresa Garriga, MD
Role: primary
Victoria Cardona, MD
Role: primary
J.V. Castelló Carrascosa
Role: primary
J.L. Pérez Formoso
Role: primary
Pilar Lara de la Rosa
Role: primary
Enrique Burches, MD
Role: primary
Miguel Angel Diaz, MD
Role: primary
Miguel Tortajada, MD
Role: primary
Other Identifiers
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PRO-ACAROS-2018-01
Identifier Type: -
Identifier Source: org_study_id
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