Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers

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