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

Cytos Biotechnology

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hypersensitivity

Treatments

Biological: CYT005-AllQbG10

Study type

Interventional

Funder types

Industry

Identifiers

NCT00293904

CYT005-AllQbG10 02

Details and patient eligibility

About

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

Enrollment

36 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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