Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT00293904
Status:
COMPLETED
Last Update Posted:
2007-09-20
First Post:
2006-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of an Allergen Vaccine in Grass-Pollen Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-19', 'studyFirstSubmitDate': '2006-02-17', 'studyFirstSubmitQcDate': '2006-02-17', 'lastUpdatePostDateStruct': {'date': '2007-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nasal Provocation Tests'}], 'secondaryOutcomes': [{'measure': 'Allergy and Medication Questionnaires'}]}, 'conditionsModule': {'keywords': ['Allergy', 'Grass Pollen', 'Systemic Immunotherapy'], 'conditions': ['Hypersensitivity']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years of age\n* 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\n* Female participants must meet one of the following criteria:\n\nNo 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)\n\n* Written informed consent\n* Patient is willing and able to comply with all trial requirements\n\nExclusion Criteria:\n\n* Additional allergies (seasonal or perennial) of which the symptoms overlap temporally with the screening and treatment period\n* Contraindication to Allergen Preparation\n* Contraindication for Nasal Provocation Test\n* Contraindication for Skin Prick Test\n* Actual significant obstructive pulmonary disorder (FEV1\\< 70%)\n* Pharmacological treatment that could affect allergic sensitivity during the trial\n* Presence or history of significant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological, and psychiatric disease as judged by the investigator\n* Serum test positive for HIV, HBV, or HCV\n* Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination\n* Pregnancy or lactation\n* Blood donation within 30 days before enrolment\n* History of abuse of alcohol or other recreational drugs\n* Specific immunotherapy against pollen allergy within the last two years\n* Intake of an investigational drug within three month before enrolment\n* Intake of contraindicated medicaments for SIT as Betablockers, ACE/ATII Inhibitors'}, 'identificationModule': {'nctId': 'NCT00293904', 'briefTitle': 'Safety and Efficacy of an Allergen Vaccine in Grass-Pollen Allergy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytos Biotechnology AG'}, 'officialTitle': 'Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (CYT005-AllQbG10) in Subjects With Seasonal Rhinoconjunctivitis Due to Grass-Pollen Allergy', 'orgStudyIdInfo': {'id': 'CYT005-AllQbG10 02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CYT005-AllQbG10', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital of Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Gabriela Senti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytos Biotechnology AG', 'class': 'INDUSTRY'}}}}