Evaluation of Efficacy and Safety of Nicotine-Qbeta (NicQb) Vaccine Versus Placebo in Healthy Smokers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 341
- 试验地点
- 6
- 主要终点
- Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm
时间窗: 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
时间窗: 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)
时间窗: Baseline, and at various times up to month 12
次要结局
- Craving and withdrawal symptoms by Questionnaire on Smoking Urges and Wisconsin Withdrawal Scale(Baseline, monthly up to month 6)