NCT00598325已完成1 期
Phase 2 Single Center, Open-label Study to Assess Immunogenicity and Safety of 6 Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®)in Smokers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Anti-nicotine antibody concentration
研究概览
简要总结
Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy smoker, ≥10 cigarettes per day for 6 months, exhaled carbon monoxide ≥10 ppm
- •Written informed consent
- •Negative urine pregnancy test, and willing to use birth control during the study, if applicable
排除标准
- •Prior exposure to nicotine vaccine
- •Clinically significant allergic reactions, especially to components of the vaccine
- •Serious or unstable clinical disease within the past 6 months
- •Use of any smoking cessation therapy within 30 days preceding 1st dose
- •Immunosuppression, due to: steroids or other immunosuppressants in the last 30 days, history of cancer or cancer treatment in the last 60 months, known HIV infection, or congenital or acquired immunodeficiency
- •Use of any vaccine other than influenza vaccine within 30 days prior to each study dose
- •Use of another IND drug or device within 30 days preceding 1st dose
- •Inability to follow the protocol, or illicit drug use in the past 12 months, or psychiatric disorder in the past 3 months
结局指标
主要结局
Anti-nicotine antibody concentration
时间窗: 12 time points between screening and week 20
次要结局
- Vaccine reactogenicity(for 7 days after each dose)
- Adverse events(for 30 weeks after 1st dose (4 wk after last dose))
研究者
研究点 (2)
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