Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or rhinoconjunctivitis with or without asthma. Primary variable: number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
Investigator(s): Approximately 10 study centers (allergy services) in Spain Planned study period: MAY 2012 (first subject in) - MAR 2013 (last subject out) Objectives: Primary objective: to evaluate the safety of a 4-month treatment with an extract of Depigoid® Dermatophagoides pteronyssinus or a mixture of 50% Dermatophagoides pteronyssinus and 50% Dermatophagoides farinae at a concentration of 500 DPP/ml administered following a rush build-up regimen. Secondary objective: to assess the subjects' immunologic responses to the above treatment. Study design: This is a prospective, non-randomized, uncontrolled, open-label safety study. When the first 29 subjects have completed the study, an interim analysis will be conducted to check whether the number of systemic reactions in these subjects is below a predefined limit. Planned number of subjects: 103 subjects in total. Medical condition or disease under investigation: Allergic rhinitis or rhinoconjunctivitis, with or without mild persistent or intermittent asthma. Test product, dose and mode of administration: Depigoid® D. pteronyssinus or Depigoid® 50% D. pteronyssinus / 50% D. farinae (500 DPP/ml). Dose: Week 0: 0.2 ml followed by 0.3 ml after 30 min Week 4, 8, 12, and 16: 0.5 ml Mode of administration: subcutaneous injection Duration of treatment: 16 weeks. Criteria for evaluation: Safety: Local and systemic adverse reactions (EAACI classification); adverse events. Efficacy: Immunologic response to the treatment. Statistical methods: Primary variable: number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period. Analysis of primary variable: exact binomial test
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
8
Depigoid® D. pteronyssinus or Depigoid® 50% D. pteronyssinus / 50% D. farinae (500 DPP/ml). Dose: Week 0: 0.2 ml followed by 0.3 ml after 30 min Week 4, 8, 12, and 16: 0.5 ml Mode of administration: subcutaneous injection
Complejo Hospitalario Torrecárdenas
Almería, Andalusia, Spain
Clínica Doctor Lobatón
Cadiz, Andalusia, Spain
Hospita Universitario Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Al·lergo Centre
Barcelona, Catalonia, Spain
Centro Médico Teknon
Barcelona, Catalonia, Spain
Hospital Universitario Vall d'Hebrón
Barcelona, Catalonia, Spain
Hospital Universitario de Bellvitge
Barcelona, Catalonia, Spain
Hospital Universitario Joan XXIII
Tarragona, Catalonia, Spain
Complejo Hospitalario Universitario de Cartagena
Cartagena, Murcia, Spain
Primary variable
Number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
Time frame: 4 months
Secondary variables
Secondary variables, which will be analyzed descriptively, are the * Number of subjects \[%\] suffering immediate and/or delayed systemic reactions broken down by grade (EAACI classification). * Number of subjects \[%\] suffering immediate and/or delayed local reactions broken down by diameter (\< 5 cm, 5-10 cm or \> 10 cm). * Number of immediate and/or delayed systemic reactions broken down by grade (EAACI classification). * Number of immediate and/or or delayed local reactions broken down by diameter (\< 5 cm, 5-10 cm and \> 10 cm). * Immunologic response to the treatment.
Time frame: 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.