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

NCT00293904 | Completed Phase 1

• 1 other identifier: CYT005-AllQbG10 02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Hypersensitivity

Keywords

Allergy; Grass Pollen; Systemic Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Nasal Provocation Tests

Secondary Outcomes (1)

• Allergy and Medication Questionnaires

Interventions

CYT005-AllQbG10 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytos Biotechnology AG: lead

Study Sites (1)

University Hospital of Zürich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Gabriela Senti, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 17, 2006
• First Posted: February 20, 2006
• Study Start: February 1, 2006
• Study Completion: February 1, 2007
• Last Updated: September 20, 2007

Record last verified: 2007-09

Locations

CH (1)