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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Hypersensitivity
Rhinitis, Allergic, Seasonal
Immune System Diseases
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on September 18, 2014