CompletedNCT02881879Updated Oct 20, 2017

Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House Dust Mites

A Phase 1 interventional study of Allergovac depot DPT/DF (50:50) in Allergic Rhinoconjunctivitis, sponsored by Roxall Medicina España S.A. Completed at 5 sites in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-10-20.

Sponsored by Roxall Medicina España S.A · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 43
Allocation: Not applicable
Ages: 18 Years to 60 Years
Sex: All

Study summary

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

Read the detailed description

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

Conditions studied

Allergic Rhinoconjunctivitis

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In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 43 is below the median of 100 across 299 interventional studies indexed under Conjunctivitis.

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Lead sponsor

Roxall Medicina España S.A is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients must sign the informed consent form
Patients must be between 18 and 60 years of age
Patients with perennial allergic rhinoconjunctivitis against HDM during a minimum of 1 year prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2015)
Patients who obtained a prick test result ≥ 3 mm diameter to HDM. Positive and negative control of the test should give consistent results
Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to HDM
Patients sensitized to HDM with clinically relevant symptoms in which treatment with HDM (50:50) vaccine is indicated
Women of childbearing potential must have a negative urine pregnancy test at visit 1
Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active

Exclusion criteria

Exclusion Criteria:

Patients who received immunotherapy in the previous 5 years for HDM or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen
Patients with severe asthma or forced expiratory volume in 1 second FEV1 \< 70% even if the are pharmacologically controlled
Polysensitized patients besides other airborne allergens Dermatophagoides pteronyssinus and Dermatophagoides farinae, which according to the investigator may present clinically relevant to those other airborne allergens while participating in this study
Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study
Patients with a previous history of anaphylaxis
Patients with active chronic urticaria
Patients with active severe atopic eczema
Patients who have participated in another clinical trial within 3 month prior to enrollment
Patients under treatment with tricyclic antidepressives, phenothiazines, β- blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
Female patients who are pregnant or breast-feeding
Patient who does not attend the visits
Patient's lack of collaboration or refusal to participate

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 43 participants (actual)

Study arms

Experimental
Allergovac depot with HDM extract
Extract of mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae (50:50) adsorbed onto aluminum hydroxide 0.33%.
Biological: Allergovac depot DPT/DF (50:50)

Interventions

BiologicalAllergovac depot DPT/DF (50:50)
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

What researchers measure

Primary outcomes

Incidence of Treatment-Emergent Adverse Events
Time frame: From date inform consent is signed until the date the treatment is completed, assessed up to 5 months

Secondary outcomes

Immunoglobulin level changes
Time frame: Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)
Skin prick test reactivity
Time frame: Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)

Study locations

5 sites

Hospital Germans Triasl i Pujol
Badalona, Barcelona 08916, Spain
Hospital de Bellvitge
Barcelona, Spain
Hospital de Basurto
Bilbao, Spain
Hospital de Valdecilla
Santander, Spain
Hospital Universitario de Araba
Vitoria, Spain

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02881879
Lead sponsor: Roxall Medicina España S.A
Responsible party: Sponsor
First posted: Aug 29, 2016
Start date: Jul 2016
Primary completion: Sep 2017
Completion: Sep 2017
Last update: Oct 20, 2017

Study contacts

Araitz Landeta

study chair · Roxall Medicina España S.A

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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