2009年甲型H1N1流感对中国医疗卫生系统造成极其严重的负担,迫切需要使用疫苗作为减轻公共卫生危害的主要干预措施。估计全球甲型H1N1疫苗的总产能是30亿剂,我国约为2亿多剂。继世界卫生组织发布2009年甲型H1N1流感疫苗推荐之后,包括中国在内的多个国家和地区均发布了疫苗使用指南,其核心是在疫苗剂量有限的情况下,优先在重点人群中接种疫苗,以确保医疗卫生系统和国家关键设施的健全,降低发病率和死亡率,降低大流感病毒在社区的传播。

2009年4月墨西哥出现一种新的甲型H1N1流行性感冒(简称流感)暴发,并在短短的2个月内传播到全球.6月11日世界卫生组织(WHO)把流感大流行警戒级别提升为最高的6级,表明世界正处在2009年流感大流行的开端[1].

Objective To evaluate the safety and immunogenicity of a trivalent split influenza virus vaccine produced by Sinovac Biotech Co.,Ltd.Methods The clinical trial was carmed out by Guangxi Zhuang Nationality Municipality Center for Disease Control and Prevention in Nanning City and Liucheng County of Guangxi from June,2003 to September 10,2003.1332 subjects were screened from the over-6-month variedly-aged healthy persons.After vaccination,adverse events of the subjects were observed and the different types antibodies of the subjects were tested by the micro-hemagglutination inhibition(HI) test.Results One case of Redness and swelling occurred in both test group and control group,respectively.The phenomenas disappeared within 72 hours.The rate of the fever was 3.21% and 6.25% in the test group and the control group,respectively.The results showed significant statistical difference.Other adverse events were not detected.734 subjects in the test group and 163 subjects in the control group were tested by HI test.The anti-HI seroconversion rate were 50.0～84.2% and 57.7～84.0%,respectively.The Anti-HI GMT of three influenza virus(sub-)types increase from 4.2 to 11.4 folds and 5.7 to 11.6 folds for the test group and the control group,respectively,and statistical difference was not significant.Conclusion These results indicated that the trial vaccine-Anflu~(TM) has excellent safety and immunogenicty and may be suited for wide use.

RNA病毒在复制时有易出错的倾向,因此SARS病毒在传染或传代过程中易发生突变而产生不同的毒株,这种机制也利于病毒逃脱宿主的免疫系统而生存下来.许多研究也表明,不同的SARS病毒分离株的全基因组序列存在不同程度的差异,这些差异的研究无疑对SARS病毒疫苗的研制具有重要的指导意义.同时,对SARS病毒在传代过程中的遗传稳定性及核酸特性的分析,是SARS疫苗研制不可或缺的环节.采用PCR产物直接测序的方法,对2株用Vero细胞培养经过多次传代的SARS病毒进行了全基因组序列的测定,通过比较分析发现该病毒在传代过程中具有高遗传稳定性,其中检定参比株(Sino1株)2和11代全基因组序列比较有4个碱基的变化,而候选疫苗株(Sino3株)3与10代的基因组全序列仅有1个碱基的差异.SARS病毒在Vero细胞上传代的遗传稳定性表明,以此制备的灭活病毒疫苗是稳定的.