Status:
COMPLETED
Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers
Lead Sponsor:
Cytos Biotechnology AG
Conditions:
Smokers
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to help smokers quitting by vaccinating them with CYT002-NicQb. Upon vaccination, the smoker will generate antibodies directed against free nicotine. The antibodies will b...
Eligibility Criteria
Inclusion
- Written informed consent
- Age 18 to 70 years
- Smokers: \> 10 and ≤ 40 cigarettes per day and smoking history of more than 3 years
- Fageström Test for Nicotine Dependence (FTND) score ≥ 5
- Female participant must meet one of the following criteria: a) no reproductive potential due to menopause, hysterectomy, bilateral oophorectomy, or tubal ligation; b) agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 12 additional months after the last immunization
Exclusion
- Pregnant or nursing
- History of severe allergy or immunological disorders
- Blood donation within previous 30 days
- Surgery within previous 30 days
- Use of investigational drugs within previous 60 days
- Significant cardiovascular disease:
- angina pectoris
- congestive heart failure
- clinically significant murmurs
- previous angioplasty or coronary artery bypass surgery
- Active infectious disease:
- WBC \> 12 000 cells/µL
- Seropositivity for Hepatitis B and C
- History of risk behavior to acquire HIV
- Significant hepatic disease
- Significant renal disease
- Significant hematological disorder
- Significant pulmonary disease
- History of malignancy
- Autoimmune disease
- Organic neurological disorder or significant psychiatric disorder
- Use of psychoactive drug within one month before enrolment
- Abuse of drugs or alcohol
- Subjects using any concomitant medications due to chronic illness which bears a high risk of fluctuation in disease activity or exacerbations during a 12-months period such as coronary heart disease, asthma, severe COPD, chronic rheumatoid disease, diabetes, etc. should be excluded.
- Obesity: BMI \> 35 kg/m2
- Use of concomitant nicotine replacement treatment (NRT) at screening or visit 1
- Any planned surgical intervention during the study period
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT00369616
Start Date
December 1 2003
End Date
October 1 2005
Last Update
November 15 2010
Active Locations (3)
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1
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
2
University Hospital Lausanne (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
3
Lungenzentrum Hirslandenklinik Zuerich
Zurich, Canton of Zurich, Switzerland, 8029