关键词： Decontamination   Sodium hypochlorite   Polio vaccine production   Poliovirus   Disinfectant efficacy   Biosafety   Virucidal activity   Surface  

摘要： Effective decontamination procedures are critical to the successful manufacture and control of poliovirus vaccines to minimize the risk to personnel and the environment. Polio viruses have been reported to be more resistant to disinfectants than many other viruses. We assessed the efficacy of sodium hypochlorite-containing disinfectants for decontamination for three poliovirus serotypes to implement decontamination procedures that are fully compliant with the WHO GAP III and Health authorities' requirements. A 10.4 log reduction was observed with a 0.63% sodium hypochlorite solution in a suspension with high protein and high poliovirus concentrations diluted 10-fold compared with a 6 log reduction in an undiluted sample. Treatment efficacy increased with sodium hypochlorite content and decreased with sample protein content. The surface tests showed that two 1-min treatments, 5-min apart, with a 0.63% Chl sodium hypochlorite solution effectively reduced the concentration of all poliovirus serotypes by 10 log(10), irrespective of the protein and virus concentration in the sample. Sodium hypochlorite solutions lower than 0.52% were less effective for complete inactivation of poliovirus. In conclusion, we demonstrated that a high level of virus reduction (>10 log(10)) can be achieved with sodium hypochlorite solutions with poliovirus in suspension and dried on surfaces.

摘要： Background The globally synchronised introduction of inactivated poliovirus vaccine (IPV) and replacement of trivalent oral poliovirus vaccine (OPV) with bivalent OPV (bOPV) were successfully implemented in China's routine immunisation programme in May, 2016. In response to the global shortage of Salk-strain IPV, Sabin-strain IPV production was encouraged to develop and use in low-income and middle-income countries. We assessed the immunogenicity of the current routine poliovirus vaccination schedule in China and compared it with alternative schedules that use Sabin-strain IPV (sIPV) and bOPV. Methods This open-label, randomised, controlled trial recruited healthy infants aged 60-75 days from two centres in Zhejiang, China. Eligible infants were full-term, due for their first polio vaccination, weighed more than 2.5 kg at birth, were healthy on physical examination with no obvious medical conditions, and had no contraindications to vaccination. Infants were randomly assigned (1:1:1) using permuted block randomisation (block size of 12) to one of three polio vaccination schedules, with the first, second, and third doses given at ages 2 months, 3 months, and 4 months, respectively: sIPV-bOPV-bOPV (1sIPV+2bOPV group;current regimen), sIPV-sIPV-bOPV (2sIPV+1bOPV group), or sIPV-sIPV-sIPV (3sIPV group). The primary endpoint was the proportion of infants with seroconversion to each of the three poliovirus serotypes 1 month after the third dose. Serious and medically important adverse events were monitored for up to 30 days after each vaccination. We assessed immunity in the per-protocol population (all children who completed all three vaccinations and had pre-vaccination and post-vaccination laboratory data) and safety in all children who received at least one dose of study vaccine. This trial is registered with ***, NCT03147560. Results Between May 1, 2016, and Dec 1, 2017, we enrolled and randomly assigned 528 eligible infants to one of the three treatmen

摘要： The detection of the MEF-1 strain highlights the importance of using safer strains for IPV production, ideally those that are non-infectious to humans and stable enough to not acquire paralytic potential. In 2012, Japan licensed IPV manufactured with Sabin strains, the live-attenuated strains of poliovirus used to manufacture oral poliovirus vaccine (OPV).4 China licensed Sabin IPV in 2015, which helped to mitigate the effect in the country of a global shortfall in Salk IPV supply.4 Although Sabin strains are infectious, they do not generally cause paralysis unless they can mutate and acquire neurovirulence. [...]manufacturing IPV using Sabin strains presents a lower risk if there is a containment breach than using wild poliovirus strains. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the US Centers for Disease Control and Prevention.

关键词： 脊髓灰质炎病毒   轮状病毒   疫苗   免疫原性  

摘要： 分析和研究脊髓灰质炎减毒活疫苗是否会对轮状病毒减毒活疫苗的免疫原性产生影响。方法:研究对象为口服轮状病毒疫苗Rotarix,将全部接种人群分为间隔接种组(在不同天接种)和同时接种组(同一天接种),对比两组血清RV-IgA水平分布及血清阳转率。结果:间隔接种组第12个月血清RV-IgA阳转率及几何平均浓度高于同时接种组,统计学意义明显(P<0.05)。结论:同时接种脊髓灰质炎减毒活疫苗对轮状病毒减毒活疫苗的免疫原性有一定影响,主要表现在RV-IgA抗体水平方面。

关键词： 型Ⅲ型脊髓灰质炎减毒活疫苗   糖丸剂型   液体剂型   稳定性  

摘要： 目的考察口服Ⅰ型Ⅲ型脊髓灰质炎减毒活疫苗(bOPV液体疫苗)和Ⅰ型Ⅲ型脊髓灰质炎减毒活疫苗糖丸(bOPV糖丸)的运输、冻融及不同温度下的稳定性。方法将3批bOPV液体疫苗分别按陆路运输(途中模拟10次开门卸货入库)和航空运输要求进行运输稳定性试验和反复冻融5次稳定性试验,3批bOPV糖丸按陆路运输要求(途中模拟10次开门卸货入库)进行运输稳定性试验后,均于-20℃入库储存,分别于入库后第6、12、18个月取样检测病毒滴度,第24个月进行全检。同时将6批bOPV液体疫苗和6批bOPV糖丸分别于-20℃保存36个月、2~8℃保存12个月、25℃放置4周、37℃放置8 d,于不同时间点取样检测病毒滴度。采用细胞培养半数感染量(cell culture infective does 50%,CCID50)法检测上述样品病毒综合滴度及Ⅰ型、Ⅲ型分型滴度,按企业注册制造及检定规程评价疫苗效价稳定性。结果bOPV液体疫苗及bOPV糖丸2~8℃运输及bOPV液体疫苗反复冻融5次后,于-20℃保存24个月,疫苗各项质量指标检测结果均符合质量标准要求;-20℃保存36个月、2~8℃保存9个月、25℃放置1周、37℃放置2 d后,病毒滴度均符合企业注册制造及检定规程。结论bOPV在常规储运条件下具有良好的稳定性,反复冻融对bOPV液体疫苗稳定性影响有限,但储存温度和时间会对bOPV的稳定性产生不同程度的影响,在实际储运过程中应避免将其长期暴露于温度偏移情况下。

关键词： 健康儿童   肠道病毒   脊髓灰质炎病毒   非脊髓灰质炎肠道病毒   VP1基因   测序定型   流行病学特征  

摘要： 目的分析2007-2016年云南省健康儿童(≤15岁)肠道病毒的带毒状况和流行特征。方法对2007-2016年云南省采集的4417份健康儿童(≤15岁)的粪便标本进行病毒分离和VP1区基因测序定型并对病毒型别和流行特征进行分析。结果2007-2016年云南省分离到脊髓灰质炎病毒(poliovirus,PV)40株,总体分离率为0.91%(40/4417),均为疫苗株;分离到非脊髓灰质炎肠道病毒(non-polio enterovirus,NPEV)308株,总体分离率为6.97%(308/4417)。地方性流行血清型是埃可病毒11型(echovirus 11,E11)、E6、E14和E3,间断性出现血清型是E24、E29和柯萨奇病毒A组8型(coxsackievirus A8,CV-A8)等,偶然出现血清型是E19、柯萨奇病毒B组1型(coxsackievirus B1,CV-B1)和肠道病毒B组75型(enterovirus B75,EV-B75)等。结论2007-2016年云南省健康儿童中的NPEV总体分离率为6.97%,未分离到脊髓灰质炎野病毒和疫苗衍生脊髓灰质炎病毒,云南省维持无脊髓灰质炎工作良好。

关键词： 脊髓灰质炎疫苗   接种   儿童父母   知晓程度  

摘要： 目的探究郑州市1周岁儿童父母脊髓灰质炎疫苗(脊灰疫苗)接种知识调查及影响因素。方法利用社区计划免疫接种日随机抽取郑州市16个社区1 546名1周岁儿童监护人进行脊灰疫苗接种知识问卷调查,统计儿童父母知晓程度,并采用Logistic回归模型对影响儿童父母接种知识知晓程度的相关因素进行分析。结果 1 546名儿童父母中,知晓者865名,知晓率为55.95%,33.76%的父母通过医生个别宣教获得相关知识,11.19%的父母通过社区宣传栏获得相关知识,1.94%父母通过网络及其他渠道获得相关知识。单因素分析显示,父母与儿童关系的不同及不同年龄、文化程度、职业、家庭子女个数、本地居住时间、去接种门诊便利性的儿童父母脊灰疫苗接种知识知晓程度相比差异有统计学意义(P<0.05);二分类非条件Logistic回归模型分析显示,儿童父母脊灰疫苗知晓程度与儿童关系、父母年龄、文化程度、去接种门诊有关,差异有统计学意义(P<0.05),与职业、家庭子女个数、本地居住时间无明显关系,差异无统计学意义(P>0.05)。结论郑州市1周岁儿童父母脊髓疫苗接种知识知晓率较低,应加强疫苗相关知识宣教,改善儿童父母对脊灰疫苗知识、态度及行为情况。

关键词： 脊髓灰质炎病毒   颜真卿   艺术天赋   字帖   欧阳询   临摹   兄弟姐妹   补助金  

摘要： 1957年,温建荣出生于广州一户工人家庭,家有七个兄弟姐妹,他排行第五.1岁时,感染上脊髓灰质炎病毒,落下了腿部残疾.“记得小时候家里是靠拿政府补助金过日子的.但无论生活多么艰难,父母也不让我们七个兄弟姐妹辍学.”在很小的时候,温建荣就表现出了艺术天赋,小小年纪已经写得一手好字,他的舅舅是一位民间书法家,多年来积攒下不少名人字帖,如颜真卿、欧阳询,这些字帖被温建荣临摹了一遍又一遍,直到烂熟于心.

关键词： 脊髓灰质炎   病毒检测   方法比较  

摘要： 目的比较不同的脊髓灰质炎病毒(Poliovirus,PV,以下简称脊灰病毒)检测方法,为选择合理的优化检测方案提供参考。方法选取广西壮族自治区柳州市1200名2~3月龄健康婴儿,分为IPV和OPV不同序贯免疫共12组,每组100人,按照0、28、56d免疫程序接种疫苗,随机抽取各组入组时前10%的受试对象在第二剂疫苗接种前和第二、三剂疫苗接种后第7、14、28d采集粪便标本,利用实时荧光定量PCR和细胞培养法对粪便中可能存在的PV进行初筛对比,对细胞培养法分离出的阳性标本,分别用中和试验、单克隆抗体间接ELISA法和逆转录-PCR鉴定其型别,并比较3种方法分型结果的一致性。结果实时荧光定量PCR检测PV阳性率为76.4%,细胞培养法为59.7%,差异有统计学意义(χ^2=32.998,P<0.01)。中和试验、ELISA、RT-PCR 3种方法对细胞培养物中PV的检出率具有高度的一致性(Kappa>0.8)且具有较高的鉴别诊断准确性(ROC曲线面积A接近1),分型结果差异无统计学意义(P>0.05)。结论实时荧光定量PCR法对粪便中PV的检出率较细胞培养法高,但不能判断PV是否具有感染性。中和试验、ELISA、RT-PCR 3种方法对PV的分型一致性较高,可根据实验室和临床需求合理选择使用。

关键词： 脊髓灰质炎   免疫   疫苗   抗体  

摘要： 【目的】了解2016年上海市实施新的脊髓灰质炎疫苗免疫策略前后婴儿脊髓灰质炎抗体水平的变化情况,为免疫策略的优化提供参考。【方法】应用微量细胞中和实验检测上海市新的脊髓灰质炎疫苗免疫策略实施前后婴儿的抗体水平,并比较抗体水平的变化。【结果】新的脊髓灰质炎疫苗免疫策略实施前后分别检测67名和41名完成基础免疫的健康婴儿血清,其抗体阳性率Ⅰ型、Ⅲ型均达100%。几何平均滴度(GMT)在实施前后分别为Ⅰ型1∶1047.46和1∶254.70,Ⅲ型1∶513.52和1∶185.49。【结论】上海市实施新脊髓灰质炎疫苗免疫策略后婴儿脊灰抗体水平均维持在较高水平。