Safety and Efficacy of an Allergen Vaccine in Grass-Pollen Allergy

Hypersensitivity Clinical Trial

Official title:

Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (CYT005-AllQbG10) in Subjects With Seasonal Rhinoconjunctivitis Due to Grass-Pollen Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293904
• Other study ID #: CYT005-AllQbG10 02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 17, 2006
• Last updated: September 19, 2007
• Start date: February 2006
• Est. completion date: February 2007

Study information

• Verified date: September 2007
• Source: Cytos Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypersensitivity
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• CYT005-AllQbG10

Locations

Country	Name	City	State
Switzerland	University Hospital of Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Provocation Tests
Secondary	Allergy and Medication Questionnaires