关键词： 脊髓灰质炎病毒I型   抗体检测   胶体金试纸条  

摘要： 目的:为研制快速检测脊髓灰质炎病毒I型抗体的胶体金试纸条.方法:以辛酸-硫酸铵沉淀法纯化脊髓灰质炎病毒I型单克隆抗体,用柠檬酸三钠还原法制备胶体金溶液,胶体金标记单抗,再结合脊灰病毒抗原形成复合物,固定于金标垫上,将鼠抗人IgG和羊抗鼠IgG分别包被于试纸条的T(检测线)处和C(质控线)处,应用该试纸条进行性能检测.结果:以已知的脊灰病毒I型阳性血清作为检测样品,试纸条检测的灵敏度为180;特异性试验证明该试纸条与甲型肝炎病毒、乙型肝炎病毒、麻疹病毒抗体阳性血清没有交叉反应;检测结果与脊灰病毒I型疫苗抗体检测试剂盒(ELISA)试验的符合率为86.7%.结论:该试纸条检测脊灰病毒I型的抗体水平具有较好的特异性与灵敏性,适用于大规模临床血清抗体水平检测,具有良好的应用前景.

关键词： 脊髓灰质炎病毒   疫苗   减毒   神经毒力   序列分析   RNA   动物实验  

摘要： 目的研究PCR和限制性内切酶突变分析(mutant analysis by PCR and restriction enzyme cleavage,MAPREC)技术和猴体神经毒力试验(monkey neurovirulence test,MNVT)评价同一批Ⅰ型Sabin株脊髓灰质炎(脊灰)病毒神经毒力的结果差异.方法采用MAPREC技术,检测Ⅰ型Sabin株脊灰病毒神经毒力关键位点480和525位点突变率;采用MNVT病理切片分析,评价Ⅰ型Sabin株脊灰病毒神经毒力.结果 MAPREC检测待测样品核酸480和525位点突变率均值为0.460%,低于高突变参考品的1.288%.MNVT切片结果分析表明,有效猴病变分值差合格.结论对同一批样品,MAPREC与MNVT分析结果一致.

关键词： Sabin株   脊髓灰质炎   疫苗   渗透压  

摘要： 目的分析Sabin株脊髓灰质炎灭活疫苗(Vero细胞)渗透压的摩尔浓度。方法选取本所2016~2018年1季度生产的92批次Sabin株脊髓灰质炎灭活疫苗(Vero细胞)[inactivated poliomyelitis vaccine made from Sabin strains(Vero cells),sIPV],采用渗透压摩尔浓度测定仪检测其渗透压摩尔浓度,并对检测数据进行正态性检验。结果 2016~2018年生产的92批sIPV渗透压摩尔浓度数据符合正态分布(P> 0. 05),渗透压摩尔浓度均值为330. 38 mOsmol/kg,标准差为9. 38 mOsmol/kg。生产初期(2016年)与现阶段(2017~2018年)生产的sIPV渗透压摩尔浓度差异无统计学意义(P> 0. 05)。结论 sIPV渗透压摩尔浓度变化趋于稳定状态,本研究为该产品渗透压摩尔浓度限度标准的制定提供了实验依据。

关键词： Bivalent Oral Polio Vaccine   Safety   Immunogenicity lot-to-lot consistency   Children   Infants  

摘要： Background: Poliomyelitis infection continues to be endemic in few countries despite rigorous efforts for eradication. A new Bivalent Oral Polio Vaccine (BBio bOPV) was tested in a Phase Ill Clinical study. Methods: An observer blind, randomized, controlled clinical study was conducted comparing BBio bOPV with a licensed bOPV (511 bOPV). Initially in Part 1, 40 children 5-6 years of age were given a single dose of either vaccine in 1:1 ratio. In Part 2, 1080 infants of 6-8 weeks of age were received in 1:1:1:1 ratio one of the 3 lots of BBio bOPV or SII bOPV at 6, 10 and 14 weeks of age. Blood samples were collected to assess neutralizing antibody responses against Polio Type 1 and 3 viruses. Safety of the vaccines were recorded. Results: All children were seroprotected against both Type 1 and Type 3 polioviruses post-vaccination. More than 96% of the infants demonstrated seroconversion as well as seroprotection against both types of polioviruses. The geometric mean titres (GMT) for Type 1 and Type 3 antibodies were comparable between the groups. The 3 lots of BBio bOPV generated similar GMTs of Type 1 and Type 3 antibodies. In total 387 participants reported at least one adverse event and 18 serious adverse events. None of these events were vaccine related. Conclusions: The new bOPV vaccine demonstrated immunogenicity that was non-inferior to a licensed bOPV vaccine. Consistency in immune response by 3 consecutively manufactured lots was also demonstrated. The vaccine did not cause any adverse event. (C) 2019 Elsevier Ltd. All rights reserved.

摘要： Background Use of oral live-attenuated polio vaccines (OPV), and injected inactivated polio vaccines (IPV) has almost achieved global eradication of wild polio viruses. To address the goals of achieving and maintaining global eradication and minimising the risk of outbreaks of vaccine-derived polioviruses, we tested novel monovalent oral type-2 poliovirus (OPV2) vaccine candidates that are genetically more stable than existing OPVs, with a lower risk of reversion to neurovirulence. Our study represents the first in-human testing of these two novel OPV2 candidates. We aimed to evaluate the safety and immunogenicity of these vaccines, the presence and extent of faecal shedding, and the neurovirulence of shed virus. Methods In this double-blind, single-centre phase 1 trial, we isolated participants in a purpose-built containment facility at the University of Antwerp Hospital (Antwerp, Belgium), to minimise the risk of environmental release of the novel OPV2 candidates. Participants, who were recruited by local advertising, were adults (aged 18-50 years) in good health who had previously been vaccinated with IPV, and who would not have any contact with immunosuppressed or unvaccinated people for the duration of faecal shedding at the end of the study. The first participant randomly chose an envelope containing the name of a vaccine candidate, and this determined their allocation;the next 14 participants to be enrolled in the study were sequentially allocated to this group and received the same vaccine. The subsequent 15 participants enrolled after this group were allocated to receive the other vaccine. Participants and the study staff were masked to vaccine groups until the end of the study period. Participants each received a single dose of one vaccine candidate (candidate 1, S2/cre5/S15domV/rec1/hifi3;or candidate 2, S2/S15domV/CpG40), and they were monitored for adverse events, immune responses, and faecal shedding of the vaccine virus for 28 days. Shed virus isolate

摘要： Unfortunately, transmission of serotype-1 WPV in Pakistan and Afghanistan has led to a disturbing increase in reported paralytic cases: the GPEI reported 22 cases in 2017, 33 cases in 2018, and 24 cases in 2019, as of May 22.5 However, global cessation of OPV2 use did not proceed as intended everywhere.6 Outbreaks of serotype-2 circulating vaccine-derived polioviruses led to ten reported paralytic cases in 2019 (as of May 22), following the 71 reported cases in 2018, which exceeded the 33 cases caused by serotype-1 WPV in 2018.5 A response to serotype-2 circulating vaccine-derived poliovirus outbreaks requires the use of serotype-2 monovalent ***, even at high coverage, inactivated poliovirus vaccine cannot stop live poliovirus transmission in most places, as demonstrated by serotype-1 WPV transmission in Israel in 2013, which means that evidence of serotype-2 live poliovirus transmission could necessitate future OPV2 use.6 Arif Ali/AFP/Getty Images In the best-case scenario, the GPEI could aggressively stop all serotype-2 live poliovirus transmission quickly, and the world would never need to use any OPV2 in the future, which will make the new poliovirus vaccine strains unexercised insurance *** decisions to make more OPV2 must occur before completion of the clinical trials for the new OPV2 strains, fewer options will be available, which should motivate accelerated efforts to develop at least one new OPV2 strain as quickly as possible.8 The question remains: can the GPEI stop serotype-2 transmission soon, or will the world need more OPV2, and will we have the best possible vaccines available when needed? I declare no competing interests.

关键词： 免疫策略   脊髓灰质炎减毒活疫苗   Sabin株脊髓灰质炎灭活疫苗   序贯免疫  

摘要： 目的比较脊髓灰质炎(简称脊灰)免疫策略调整过程中不同免疫程序的接种效果。方法在广西壮族自治区开展三价脊灰减毒活疫苗(trivalent oral poliovirus vaccine,tOPV)、Sabin株脊灰灭活疫苗(inactivated poliovirus vaccine,IPV)和脊灰减毒活疫苗(oral poliovirus vaccine,OPV)不同序贯免疫接种,分8个免疫程序组:3剂tOPV糖丸组及液体组、2sIPV+1tOPV糖丸组及液体组、1sIPV+2bOPV糖丸组及液体组、2sIPV+1bOPV糖丸组及液体组;比较各程序组全程基础免疫后28 d血清中脊灰中和抗体阳转率及几何平均滴度(geometric mean titer,GMT)。结果全程基础免疫后sIPV+2bOPV组及2sIPV+bOPV组两种剂型Ⅰ、Ⅲ抗体GMT均高于3剂tOPV组,Ⅱ型抗体阳转率及GMT均低于3剂tOPV组(P<0.001);2sIPV+bOPV组两种剂型免疫后Ⅰ、Ⅲ型抗体阳转率及GMT均高于2sIPV+tOPV组;IPV/bOPV序贯免疫中,接种2剂IPV后的Ⅰ、Ⅱ、Ⅲ型抗体阳转率及GMT均高于接种1剂IPV,且Ⅱ型抗体阳转率和Ⅱ、Ⅲ抗体GMT差异均有统计学意义(P<0.001)。结论脊灰免疫策略转换前后不同的免疫程序疫苗接种效果存在差异,建议在IPV供应充足的情况下逐步增加IPV剂次,减少bOPV剂次,实现最终全程接种IPV。

关键词： 脊髓灰质炎疫苗   序贯接种   免疫效果   安全性  

摘要： 口服脊髓灰质炎减毒活疫苗(oral poliomyelitis attenuated live vaccine,OPV)和脊髓灰质炎灭活疫苗(inactivated poliomyelitis vaccine,IPV)的实施在消灭脊髓灰质炎(poliomyelitis)中发挥了重要作用,但仍存在疫苗相关麻痹型脊髓灰质炎(vaccine-associated paralytic poliomyelitis,VAPP)和疫苗衍生脊髓灰质炎病毒(vaccine-derived poliovirus,VDPV)病例的发生。为避免该风险,中国自2016年5月1日起停用三价OPV(trivalent oral poliomyelitis attenuated live vaccine,t OPV),改用二价脊髓灰质炎减毒活疫苗(bivalent oral poliomyelitis attenuated live vaccine,bOPV),并将IPV纳入国家免疫规划(national immunization program,NIP),即采用IPV-OPV-OPV-OPV序贯免疫程序进行接种,不仅能降低VAPP的发生,还能维持较高的肠道黏膜免疫力。本文就国内不同IPV-OPV序贯免疫程序的应用、免疫效果及安全性作一综述。

关键词： 脊髓灰质炎灭活疫苗   脊髓灰质炎减毒活疫苗   脊髓灰质炎疫苗   山西省   无脊髓灰质炎目标   补种   世界卫生组织   免疫策略  

摘要： 我国于2000年成功实现了无脊髓灰质炎目标,我省于1993年再无脊髓灰质炎病例.为做好脊髓灰质炎防控工作,维持我国无脊髓灰质炎状态,按照《2003—2010年全国保持无脊髓灰质炎状态行动计划》,维持高水平的脊髓灰质炎疫苗(IPV)接种率是重要技术策略和措施之一.按照世界卫生组织(WHO)的建议,我国自2016年5月1日起实施新的脊髓灰质炎疫苗免疫策略,停用三价脊髓灰质炎减毒活疫苗(tOPV),由二价脊髓灰质炎减毒活疫苗(bOPV)替代,并将IPV纳入国家免疫规划.脊髓灰质炎疫苗免疫策略调整,是全球消灭脊髓灰质炎的统一行动,也是我国脊髓灰质炎防控工作的实际需要.疫苗转换初期,IPV供应不足致部分儿童缺漏IPV免疫.

关键词： 脊髓灰质炎病毒   细胞敏感性   细胞支原体  

摘要： 目的评价辽宁省脊灰实验室2015-2018年所用细胞系的质量控制情况,为急性驰缓性麻痹(acute flaccid paralysis)病例监测提供可靠的质量保证。方法以辽宁省脊灰实验室2013年制备的脊灰病毒Ⅰ、Ⅱ、Ⅲ型质量控制(Laboratory quality control standard,LQC)株为标准毒株,转脊灰病毒受体的小鼠肺细胞(L20B细胞)和横纹肌肉瘤细胞细胞(RD细胞)由中国疾病预防控制中心脊灰实验室提供。支原体的检测用PCR方法,细胞敏感性检测用标准毒株滴定法。结果辽宁省脊灰实验室2015-2018年使用的L20B和RD细胞系支原体检测均为阴性,两种细胞系的病毒滴度与LQC参考值比较波动幅度均在±0.5 log CCID50/0.1 ml以内。结论 2015-2018年辽宁省脊灰实验室使用的细胞系状态稳定,无支原体污染,对脊灰病毒敏感性良好,为脊灰实验室网络运转和辽宁省AFP病例监测提供了准确、可靠的病毒学依据。