Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers

This study has been completed.
Sponsor:
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00369616
First received: August 25, 2006
Last updated: November 11, 2010
Last verified: March 2008
  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 2

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

Resource links provided by NLM:


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)
Arms Assigned Interventions
Experimental: NicQb vaccine Biological: CYT002-NicQb
Placebo Comparator: Placebo vaccine Biological: CYT002-NicQb

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Switzerland
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
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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00369616     History of Changes
Other Study ID Numbers: CYT002-NicQb 02
Study First Received: August 25, 2006
Last Updated: November 11, 2010
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on September 18, 2014