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Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00369616
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : November 15, 2010
Information provided by:
Cytos Biotechnology AG

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 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 or disease Intervention/treatment Phase
Smokers Biological: CYT002-NicQb Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Nicotine-Qbeta (NicQb) Vaccine Versus Placebo in Healthy Smokers
Study Start Date : December 2003
Actual Primary Completion Date : March 2005
Actual Study Completion Date : October 2005

Arm Intervention/treatment
Experimental: NicQb vaccine Biological: CYT002-NicQb
Placebo Comparator: Placebo vaccine Biological: CYT002-NicQb

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. Craving and withdrawal symptoms by Questionnaire on Smoking Urges and Wisconsin Withdrawal Scale [ Time Frame: Baseline, monthly up to month 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00369616

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University Hospital Lausanne (CHUV)
Lausanne, Vaud, Switzerland, 1011
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Lungenzentrum Hirslandenklinik Zuerich
Zuerich, Switzerland, 8029
Sponsors and Collaborators
Cytos Biotechnology AG
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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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00369616    
Other Study ID Numbers: CYT002-NicQb 02
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: November 15, 2010
Last Verified: March 2008