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