Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers - Full Text View

Sponsor:	Cytos Biotechnology AG
Information provided by:	Cytos Biotechnology AG
ClinicalTrials.gov Identifier:	NCT00369616

Purpose

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 bind nicotine and prevent its passage into the brain. The successfully vaccinated smoker will have no reward effect after smoking, thus braking the vicious circle of nicotine addiction.

Condition	Intervention	Phase
Smokers	Biological: CYT002-NicQb	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Efficacy and Safety of Nicotine-Qbeta (NicQb) Vaccine Versus Placebo in Healthy Smokers

Resource links provided by NLM:

MedlinePlus related topics: Smoking

U.S. FDA Resources

Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:

Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm [ Time Frame: Monthly up to month 6, and during follow-up at months 9 and 12 ] [ Designated as safety issue: No ]
Immunogenicity of the vaccine, by measuring specific anti-nicotine IgG antibodies by ELISA [ Time Frame: Baseline, monthly up to month 6, and months 9 and 12 ] [ Designated as safety issue: No ]
Safety and tolerability by recording adverse events, injection site examinations, vital signs, standard clinical laboratory (serum chemistry, hematology) [ Time Frame: Baseline, and at various times up to month 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Craving and withdrawal symptoms by Questionnaire on Smoking Urges and Wisconsin Withdrawal Scale [ Time Frame: Baseline, monthly up to month 6 ] [ Designated as safety issue: No ]

Enrollment:	341
Study Start Date:	December 2003
Study Completion Date:	October 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369616

Locations

Switzerland
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Lungenzentrum Hirslandenklinik Zuerich
Zuerich, Switzerland, 8029
Switzerland, Vaud
University Hospital Lausanne (CHUV)
Lausanne, Vaud, Switzerland, 1011

Sponsors and Collaborators

Cytos Biotechnology AG

Investigators

Study Chair:	Jacques Cornuz, Prof.	Department of Medicine; University Hospital Lausanne, Switzeland
Principal Investigator:	Thomas Cerny, Prof.	Department of Medicine, Kantonsspital St. Gallen, Switzerland
Principal Investigator:	Felix Jungi, MD	Department of Medicine, Kantonsspital St. Gallen, Switzerland
Principal Investigator:	Karl Klingler, MD	Lung Center Hirslanden, Zuerich, Switzerland

More Information

No publications provided by Cytos Biotechnology AG

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Cornuz J, Zwahlen S, Jungi WF, Osterwalder J, Klingler K, van Melle G, Bangala Y, Guessous I, Müller P, Willers J, Maurer P, Bachmann MF, Cerny T. A vaccine against nicotine for smoking cessation: a randomized controlled trial. PLoS ONE. 2008 Jun 25;3(6):e2547.

Study ID Numbers:	CYT002-NicQb 02
Study First Received:	August 25, 2006
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00369616 History of Changes
Health Authority:	Switzerland: Swissmedic

ClinicalTrials.gov processed this record on November 05, 2009