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

NCT01591343 | Terminated Phase 2 DMC

• 1 other identifier: 101-PG-PSC-186
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Allergic Rhinitis; Rhinoconjunctivitis; Mild Persistent Asthma; Mild Intermittent Asthma

Keywords

Specific immunotherapy; Allergic rhinitis; Allergic rhinoconjunctivitis; Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (1)

• Secondary variables

  4 months

Study Arms (1)

Depigoid® (500 DPP/ml)

EXPERIMENTAL

Patients will receive either Depigoid® Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), depending on their sensitization to one or both mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae).

Biological: Depigoid® (500 DPP/ml)

Interventions

Depigoid® (500 DPP/ml) BIOLOGICAL

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

Depigoid® (500 DPP/ml)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between 18 and 55 years of age (both inclusive).
• Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year -- with or without symptoms of mild persistent or intermittent allergic asthma which is controlled with a dose less or equal to 400 µg/day budesonide or an equivalent -- caused by a clinically relevant sensitization to house dust mites (Dermatophagoides pteronyssinus or Dermatophagoides pteronyssinus and Dermatophagoides farinae).
• The IgE-mediated sensitization will be demonstrated by means of the following: medical history and IgE specific to house dust mites (D. pteronyssinus or D. pteronyssinus and D. farinae) CAP RAST ≥ 2 and positive skin prick test. A skin prick test will be considered positive when it produces a wheal of at least 3 mm according to the largest diameter.
• Asthmatic patients must be stable and on a stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study.

You may not qualify if:

• Any contraindication for treatment with allergen specific immunotherapy.
• Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value \< 80% of the predicted normal value.
• Allergy symptoms due to sensitization to pollens or other perennial allergens (molds, epithelia).
• Subjects with typical symptoms to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelial cells cannot participate in this study. Patients sensitized to pollens with specific IgE CAP RAST \< 2 can be included in this study provided that they do not present symptoms as a consequence of this sensitization. Patients sensitized to animal epithelia who do not present symptoms can participate in this study provided that they are not exposed to the allergen to which they are sensitized, even though they present specific IgE with CAP RAST ≥ 2. If they were exposed to the animal in question, these subjects must have a specific IgE with CAP RAST \< 2 in order to participate in the study.
• Asthma requiring a dose \> 400 µg/day of Budesonide or an equivalent, without long-lasting beta-2 agonists, to reach control according to the Global Initiative for Asthma (GINA 2010).
• Patients with non controlled bronchial asthma within 3 months prior to Visit 1.
• Patients with asthma who have been treated with systemic steroids within 3 months prior to V1.
• Patients with hospital admission due to asthma exacerbations within 1 year prior to V1
• Acute or chronic inflammatory or infectious diseases of the airways.
• Chronic structural diseases of the respiratory system (for example, emphysema or bronchiectasis).
• Immune system diseases, both autoimmune diseases and immunodeficiency.
• Any disease involving a contraindication for the use of adrenaline (for example, hyperthyroidism).
• Serious uncontrolled diseases involving a risk for the subjects participating in this study, including the following for example: heart failure, serious or uncontrolled respiratory diseases, endocrine diseases, clinically relevant liver or kidney diseases or hematological diseases.
• Malignant disease with activity in the last 5 years.
• Clinically significant anomaly in laboratory parameters or vital signs which could involve a risk increase for the subject.

Sponsors & Collaborators

• Laboratorios Leti, S.L.: lead
• Harrison Clinical Research: collaborator

Study Sites (10)

Complejo Hospitalario Torrecárdenas

Almería, Andalusia, 04009, Spain

Location

Clínica Doctor Lobatón

Cadiz, Andalusia, 11008, Spain

Location

Hospita Universitario Dr. Negrín

Las Palmas de Gran Canaria, Canary Islands, 35010, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Al·lergo Centre

Barcelona, Catalonia, 08021, Spain

Location

Centro Médico Teknon

Barcelona, Catalonia, 08022, Spain

Location

Hospital Universitario Vall d'Hebrón

Barcelona, Catalonia, 08035, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, Catalonia, 08907, Spain

Location

Hospital Universitario Joan XXIII

Tarragona, Catalonia, 43007, Spain

Location

Complejo Hospitalario Universitario de Cartagena

Cartagena, Murcia, 03020, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 4, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

ES (10)