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

Cytos Biotechnology

Status and phase: Completed; Phase 2; Phase 1

Conditions: Perennial Allergic Rhinoconjunctivitis; Allergic Asthma

Treatments: Biological: CYT005-AllQbG10

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652223

CYT005-AllQbG10 01

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

1

Experimental group

Treatment:

Biological: CYT005-AllQbG10