Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy (SCIT) with House Dust Mite (HDM) extract in patients with rhinoconjunctivitis with or without associated mild asthma and sensitized to HDM. In addition,surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
It will be recruited 50 patients susceptible to receive SCIT with HDM extract along 5 participating spanish sites.
Primary endpoint of the study is to assess the safety and tolerability of subcutaneous immunotherapy in depot presentation and quick pattern in patients with rhinoconjunctivitis with or without mild asthma sensitized to house dust mites
Secondary objective is to evaluate the indirect immunotherapy efficacy through the measurement of immunoglobulin level changes and cutaneous reactivity
The aim of present clinical trial is to go deeper into the safety of the vaccine of mixture of DPT and DF (50:50). Although this is the first clinical trial to date to be performed with this vaccine, there have been two clinical trials with the same formulation and DPT 100% as active ingredient( NºEudraCT: 2009-016277-15 and NºEudraCT: 2011-004583-30). Given that there is a remarkable cross-reactivity between the DPT and DF mites, the results of the two clinical trials conducted to date with subcutaneous depot vaccine with Dermatophagoides pteronyssinus 100% extract mite, are very significant
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allergovac depot with HDM extract | Experimental | Extract of mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae (50:50) adsorbed onto aluminum hydroxide 0.33%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergovac depot DPT/DF (50:50) | Biological | Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly dose increasing injections at the initiation phase plus 3 maintenance monthly injections |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | From date inform consent is signed until the date the treatment is completed, assessed up to 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin level changes | Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit) | |
| Skin prick test reactivity | Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Araitz Landeta | Roxall Medicina España S.A | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Triasl i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital de Bellvitge |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Barcelona |
| Spain |
| Hospital de Basurto | Bilbao | Spain |
| Hospital de Valdecilla | Santander | Spain |
| Hospital Universitario de Araba | Vitoria-Gasteiz | Spain |