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

An Open, Multicenter Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House

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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinoconjunctivitis
• Intervention / Treatment: Biological: Allergovac depot DPT/DF (50:50)

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

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients must sign the informed consent form
2. Patients must be between 18 and 60 years of age
3. 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)
4. Patients who obtained a prick test result ≥ 3 mm diameter to HDM. Positive and negative control of the test should give consistent results
5. Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to HDM
6. Patients sensitized to HDM with clinically relevant symptoms in which treatment with HDM (50:50) vaccine is indicated
7. Women of childbearing potential must have a negative urine pregnancy test at visit 1
8. Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active

Exclusion Criteria:

1. 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
2. Patients with severe asthma or forced expiratory volume in 1 second FEV1 < 70% even if the are pharmacologically controlled
3. 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
4. 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
5. Patients with a previous history of anaphylaxis
6. Patients with active chronic urticaria
7. Patients with active severe atopic eczema
8. Patients who have participated in another clinical trial within 3 month prior to enrollment
9. Patients under treatment with tricyclic antidepressives, phenothiazines, β- blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
10. Female patients who are pregnant or breast-feeding
11. Patient who does not attend the visits
12. Patient's lack of collaboration or refusal to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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 is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Roxall Medicina España S.A
• Investigators: Study Chair: Araitz Landeta, Roxall Medicina España S.A

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: BIA-HDMD-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No