Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

Allergic Asthma Clinical Trial

Official title:

Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (AllQbG10) in Subjects With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652223
• Other study ID #: CYT005-AllQbG10 01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 1, 2008
• Last updated: April 4, 2008
• Start date: March 2005
• Est. completion date: November 2005

Study information

• Verified date: April 2008
• Source: Cytos Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to test the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Mild to moderate perennial allergic rhinoconjunctivitis due to sensitization against house dust mites

• Mild asthma

• Females only if non-reproductive or agree to practice an effective and accepted method of contraception

Exclusion Criteria:

• Relevant cardiovascular, renal, pulmonary or endocrine disease

• History of autoimmune disease

• Severe allergies

• History of active infectious disease

• Current diagnosis or history of malignancy

• Relevant neurological or psychiatric disorder

• Pregnancy or lactation

• History of alcohol abuse or other recreational drugs

• Use of an investigational drug within three month before enrolment

• Blood donation within 30 days before enrolment

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma
• Conjunctivitis
• Conjunctivitis, Allergic
• Perennial Allergic Rhinoconjunctivitis

Intervention

Biological:
• CYT005-AllQbG10
Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Department of Dermatology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Country where clinical trial is conducted

Switzerland,