Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Efficacy and Safety of Nicotine-Qbeta (NicQb) Vaccine Versus Placebo in Healthy Smokers

Conditions
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Smokers

Intervention / Treatment
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* Biological: CYT002-NicQb


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NicQb vaccine<br> | Biological: CYT002-NicQb<br> <br> |
| Placebo Comparator: Placebo vaccine<br> | Biological: CYT002-NicQb<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm |  | Monthly up to month 6, and during follow-up at months 9 and 12 | 
| Immunogenicity of the vaccine, by measuring specific anti-nicotine IgG antibodies by ELISA |  | Baseline, monthly up to month 6, and months 9 and 12 | 
| Safety and tolerability by recording adverse events, injection site examinations, vital signs, standard clinical laboratory (serum chemistry, hematology) |  | Baseline, and at various times up to month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving and withdrawal symptoms by Questionnaire on Smoking Urges and Wisconsin Withdrawal Scale |  | Baseline, monthly up to month 6 |