CAPHRI School for Public Health and Primary Care, Department of Family Medicine, Maastricht University, Maastricht, the Netherlands.
Addiction. 2014 Aug;109(8):1252-9. doi: 10.1111/add.12573. Epub 2014 Jun 3.
Nicotine vaccination has been proposed as a possible treatment to aid smoking cessation. First efficacy results of the nicotine vaccine 3'-AmNic-rEPA (NicVAX) showed that only a subgroup of the top 30% antibody responders achieved higher abstinence rates than placebo. The present study examined the efficacy of adding NicVAX versus placebo to varenicline and behavioural support as an aid in smoking cessation and relapse prevention.
Randomized placebo-controlled trial.
Two research centres (Maastricht University Medical Centre and Slotervaart Hospital) in the Netherlands.
A total of 558 smokers were assigned randomly to six injections with NicVAX (n = 278) or placebo (n = 280) both co-administered with open label varenicline and behavioural support.
Outcomes were prolonged carbon monoxide-validated abstinence from weeks 9 to 52 (primary) and weeks 37 to 52 (secondary). We also performed a pre-planned subgroup analysis in the top 30% antibody responders.
There was no difference in abstinence rates between NicVAX and placebo from weeks 9 to 52 [27.7 versus 30.0%, odds ratio (OR) = 0.89, 95% confidence interval (CI) = 0.62-1.29] or weeks 37 to 52 (33.8 versus 33.2%, OR = 1.03, 95% CI = 0.73-1.46). The top 30% antibody responders, compared to the placebo group, showed a non-significant tendency towards higher abstinence rates from weeks 37 to 52 (42.2 versus 33.2%, OR = 1.47, 95% CI = 0.89-2.42).
The nicotine vaccine, NicVAX, does not appear to improve the chances of stopping smoking when given in addition to varenicline and behavioural support.
尼古丁疫苗被提议作为一种可能的治疗方法来帮助戒烟。尼古丁疫苗 3'-AmNic-rEPA（NicVAX）的初步疗效结果表明，只有前 30%抗体应答者中的一个亚组比安慰剂组实现了更高的戒烟率。本研究探讨了在伐伦克林和行为支持的基础上添加 NicVAX 与安慰剂相比，对戒烟和预防复发的疗效。
随机安慰剂对照试验。
荷兰马斯特里赫特大学医学中心和斯劳特瓦尔特医院的两个研究中心。
共有 558 名吸烟者被随机分配接受六次 NicVAX（n=278）或安慰剂（n=280）注射，同时给予开放标签的伐伦克林和行为支持。
主要终点是从第 9 周到第 52 周（第 1 次）和从第 37 周到第 52 周（第 2 次）延长的经一氧化碳验证的戒烟率。我们还对前 30%抗体应答者进行了预先计划的亚组分析。
从第 9 周到第 52 周（27.7%对 30.0%，比值比[OR] 0.89，95%置信区间[CI] 0.62-1.29）或第 37 周到第 52 周（33.8%对 33.2%，OR 1.03，95% CI 0.73-1.46），NicVAX 和安慰剂组的戒烟率没有差异。与安慰剂组相比，前 30%抗体应答者在第 37 周到第 52 周的戒烟率有显著的提高趋势（42.2%对 33.2%，OR 1.47，95% CI 0.89-2.42）。
当尼古丁疫苗 NicVAX 与伐伦克林和行为支持联合使用时，似乎并不能提高戒烟的机会。
