A Phase 2 Study to Assess Safety and Immunogenicity of Five Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) Administered to Smokers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Anti-nicotine Antibody concentrations
研究概览
简要总结
Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.
详细描述
Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current smoker
- •Good general health, including mental health
- •Alveolar carbon monoxide level greater than or equal to 10 ppm
排除标准
- •Prior exposure to NicVAX
- •Known allergy to any of the components of NicVAX
- •Use of any smoking cessation aide
- •Pregnant or breastfeeding
结局指标
主要结局
Anti-nicotine Antibody concentrations
时间窗: 19 time points from Day 0 to 365
次要结局
- Safety: vaccine reactogenicity(7 days after each dose)
- Safety: adverse events(Day 0-365)
- Smoking cessation(periods of 2 weeks, 4 weeks, or 12 weeks duration)
- Fagerstrom Test for Nicotine Dependence(7 time points from Day 0 to 365)