Clinical trial NCT00293904: Safety and Efficacy of an Allergen Vaccine in Grass-Pollen Allergy
Official title: Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (CYT005-AllQbG10) in Subjects With Seasonal Rhinoconjunctivitis Due to Grass-Pollen Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypersensitivity
Keywords: Allergy
Grass Pollen
Systemic Immunotherapy
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2006-02-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 decrease of sensitivity against pollen than with the grass pollen allergen alone


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Nasal Provocation Tests
Secondary outcomes:
measure: Allergy and Medication Questionnaires
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital of Zürich
Study officials:
affiliation: University of Zurich
name: Gabriela Senti, MD
role: PRINCIPAL_INVESTIGATOR
References: