Clinical trial NCT00369616: Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers
Official title: Evaluation of Efficacy and Safety of Nicotine-Qbeta (NicQb) Vaccine Versus Placebo in Healthy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smokers
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm
timeFrame: Monthly up to month 6, and during follow-up at months 9 and 12
measure: Immunogenicity of the vaccine, by measuring specific anti-nicotine IgG antibodies by ELISA
timeFrame: Baseline, monthly up to month 6, and months 9 and 12
measure: Safety and tolerability by recording adverse events, injection site examinations, vital signs, standard clinical laboratory (serum chemistry, hematology)
timeFrame: Baseline, and at various times up to month 12
Secondary outcomes:
measure: Craving and withdrawal symptoms by Questionnaire on Smoking Urges and Wisconsin Withdrawal Scale
timeFrame: Baseline, monthly up to month 6
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne (CHUV)
state: Vaud
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zuerich
country: Switzerland
facility: Lungenzentrum Hirslandenklinik Zuerich
Study officials:
affiliation: Department of Medicine; University Hospital Lausanne, Switzeland
name: Jacques Cornuz, Prof.
role: STUDY_CHAIR
affiliation: Department of Medicine, Kantonsspital St. Gallen, Switzerland
name: Thomas Cerny, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine, Kantonsspital St. Gallen, Switzerland
name: Felix Jungi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lung Center Hirslanden, Zuerich, Switzerland
name: Karl Klingler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cornuz J, Zwahlen S, Jungi WF, Osterwalder J, Klingler K, van Melle G, Bangala Y, Guessous I, Muller 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. doi: 10.1371/journal.pone.0002547.