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

This study has been completed.
Sponsor:
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00293904
First received: February 17, 2006
Last updated: September 19, 2007
Last verified: September 2007
  Purpose

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


Condition Intervention Phase
Hypersensitivity
Biological: CYT005-AllQbG10
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (CYT005-AllQbG10) in Subjects With Seasonal Rhinoconjunctivitis Due to Grass-Pollen Allergy

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:
  • Nasal Provocation Tests

Secondary Outcome Measures:
  • Allergy and Medication Questionnaires

Estimated Enrollment: 36
Study Start Date: February 2006
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293904

Locations
Switzerland
University Hospital of Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
Cytos Biotechnology AG
Investigators
Principal Investigator: Gabriela Senti, MD University of Zurich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00293904     History of Changes
Other Study ID Numbers: CYT005-AllQbG10 02
Study First Received: February 17, 2006
Last Updated: September 19, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by Cytos Biotechnology AG:
Allergy
Grass Pollen
Systemic Immunotherapy

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Hypersensitivity
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014