尼古丁结合疫苗在当前吸烟者中的安全性和免疫原性。

Safety and immunogenicity of a nicotine conjugate vaccine in current smokers.

作者信息

Hatsukami Dorothy K, Rennard Stephen, Jorenby Douglas, Fiore Michael, Koopmeiners Joseph, de Vos Arjen, Horwith Gary, Pentel Paul R

机构信息

Cancer Center, Tobacco Use Research Center, University of Minnesota Medical School, 2701 University Avenue SE, Minneapolis, MN 55414, USA.

出版信息

Clin Pharmacol Ther. 2005 Nov;78(5):456-67. doi: 10.1016/j.clpt.2005.08.007.

DOI:10.1016/j.clpt.2005.08.007

PMID:16321612

Abstract

Immunotherapy is a novel potential treatment for nicotine addiction. The aim of this study was to assess the safety and immunogenicity of a nicotine conjugate vaccine, NicVAX, and its effects on smoking behavior. Smokers (N = 68) were recruited for a noncessation treatment study and assigned to 1 of 3 doses of the nicotine vaccine (50, 100, or 200 microg) or placebo. They were injected on days 0, 28, 56, and 182 and monitored for a period of 38 weeks. Results showed that the nicotine vaccine was safe and well tolerated. Vaccine immunogenicity was dose-related (P < .001), with the highest dose eliciting antibody concentrations within the anticipated range of efficacy. There was no evidence of compensatory smoking or precipitation of nicotine withdrawal with the nicotine vaccine. The 30-day abstinence rate was significantly different across the 4 doses (P = .02), with the highest rate of abstinence occurring with 200 microg. The nicotine vaccine appears to be a promising medication for tobacco dependence.

摘要

免疫疗法是一种治疗尼古丁成瘾的新型潜在疗法。本研究的目的是评估尼古丁结合疫苗NicVAX的安全性、免疫原性及其对吸烟行为的影响。招募吸烟者（N = 68）进行一项非戒烟治疗研究，并将其分配到3种剂量的尼古丁疫苗（50、100或200微克）或安慰剂中的一种。他们在第0、28、56和182天接受注射，并监测38周。结果表明，尼古丁疫苗安全且耐受性良好。疫苗免疫原性与剂量相关（P <.001），最高剂量引发的抗体浓度在预期的疗效范围内。没有证据表明使用尼古丁疫苗会出现代偿性吸烟或尼古丁戒断反应。4种剂量的30天戒烟率有显著差异（P =.02），200微克剂量的戒烟率最高。尼古丁疫苗似乎是一种有前景的治疗烟草依赖的药物。