Status:
COMPLETED
Safety and Efficacy of an Allergen Vaccine in Grass-Pollen Allergy
Lead Sponsor:
Cytos Biotechnology AG
Conditions:
Hypersensitivity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate whether the use of a specific immunomodulatory principle (QbG10) together with conventional grass pollen allergen leads to a more rapid and more pronounced dec...
Eligibility Criteria
Inclusion
- 18 to 65 years of age
- Mild to moderate seasonal allergic rhinoconjunctivitis due to sensitization against grass pollen as evident from history (≥ 2 years), and positive nasal provocation test (NPT) and positive skin prick test (SPT, wheal ≥ 3mm larger than diluent) to grass pollen extract
- Female participants must meet one of the following criteria:
- No reproductive potential due to menopause (one year without menses, in case of doubts serum FSH will be determined and must be \>40 U/mL), hysterectomy, bilateral oophorectomy, or tubal ligation. Patient agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional months after the last immunization (hormone-based, or intrauterine device, or double barrier contraception, i.e. condom + diaphragm, condom or diaphragm + spermicidal gel or foam)
- Written informed consent
- Patient is willing and able to comply with all trial requirements
Exclusion
- Additional allergies (seasonal or perennial) of which the symptoms overlap temporally with the screening and treatment period
- Contraindication to Allergen Preparation
- Contraindication for Nasal Provocation Test
- Contraindication for Skin Prick Test
- Actual significant obstructive pulmonary disorder (FEV1\< 70%)
- Pharmacological treatment that could affect allergic sensitivity during the trial
- Presence or history of significant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological, and psychiatric disease as judged by the investigator
- Serum test positive for HIV, HBV, or HCV
- Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination
- Pregnancy or lactation
- Blood donation within 30 days before enrolment
- History of abuse of alcohol or other recreational drugs
- Specific immunotherapy against pollen allergy within the last two years
- Intake of an investigational drug within three month before enrolment
- Intake of contraindicated medicaments for SIT as Betablockers, ACE/ATII Inhibitors
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00293904
Start Date
February 1 2006
End Date
February 1 2007
Last Update
September 20 2007
Active Locations (1)
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1
University Hospital of Zürich
Zurich, Canton of Zurich, Switzerland, 8091