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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00293904
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : September 20, 2007
Information provided by:
Cytos Biotechnology AG

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

Condition or disease Intervention/treatment Phase
Hypersensitivity Biological: CYT005-AllQbG10 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Hay Fever

Primary Outcome Measures :
  1. Nasal Provocation Tests

Secondary Outcome Measures :
  1. Allergy and Medication Questionnaires

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00293904

University Hospital of Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
Cytos Biotechnology AG
Principal Investigator: Gabriela Senti, MD University of Zurich Identifier: NCT00293904     History of Changes
Other Study ID Numbers: CYT005-AllQbG10 02
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: September 20, 2007
Last Verified: September 2007

Keywords provided by Cytos Biotechnology AG:
Grass Pollen
Systemic Immunotherapy

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