关键词： 脊髓灰质炎病毒疫苗   灭活   DNA污染   Vero细胞   方法  

摘要： 目的 建立Sabin株脊髓灰质炎灭活疫苗Vero细胞DNA残留量的检测方法。方法 提取Vero细胞基因组DNA，制备地高辛标记探针。比较样品不同处理方式的检测差异。对建立的残留DNA检测方法进行特异性、灵敏度和稳定性验证。结果 Vero 细胞基因组DNA的质量浓度为295 μg/ml，260 nm与280 nm波长处的吸光度比值为1.88。探针灵敏度达到0.01 pg/μl。采用苯酚抽提方式处理DNA参考品，检测灵敏度为1 ng；而用碘化钠处理DNA参考品，灵敏度达到10 pg。特异性检测表明，探针与非同源DNA无杂交。灵敏度和稳定性检测结果显示，探针于–70 ℃保存9个月，灵敏度仍为10 pg。 结论 建立了Sabin株脊髓灰质炎灭活疫苗Vero细胞DNA残留量的检测方法。采用碘化钠提取DNA，回收率高，操作简单，适用于Vero细胞的残留DNA检测。

关键词： 脊髓灰质炎病毒   细胞系敏感性实验   质量控制标准株  

摘要： 目的评价江西省疾病预防控制中心脊髓灰质炎(脊灰)实验室2013年至2015年所用细胞系对脊灰病毒的敏感性,为维持无脊灰工作提供可靠的质量保证。方法选择江西省脊灰实验室2015年制备的Sabin株Ⅰ﹑Ⅱ﹑Ⅲ型质量控制株,以及国家脊灰实验室提供的合格的无支原体污染的RD和L20B细胞系,采用96孔微量培养板滴定法测定2013年至2015年江西省江西省疾病预防控制中心脊髓灰质炎(脊灰)实验室所用细胞系对脊灰病毒的敏感性。结果江西省脊灰实验室2013~2015年细胞敏感性试验结果 :人横纹肌肉瘤细胞(RD)细胞均值及标准差为:Ⅰ型7.32±0.23,Ⅱ型6.97±0.20,Ⅲ型6.88±0.23;转人脊灰病毒受体的小鼠肺细胞系(L20B)细胞均值及标准差为:Ⅰ型7.03±0.19,Ⅱ型6.93±0.14,Ⅲ型6.62±0.18,与江西省脊灰实验室质量控制标准株(Laboratory quality control standard,LQC)的参考值相比其滴度均波动在±0.5log10CCID50/0.1ml以内。结论 2013年至2015年江西省江西省疾病预防控制中心脊髓灰质炎(脊灰)实验室所用细胞系对脊灰病毒的敏感性良好。

关键词： Inactivated polio vaccine   Intradermal injections   fractional dose IPV   Immune response  

摘要： Administration of 1/5th dose of Inactivated poliovirus vaccine intradermally (flPV) provides similar immune response as full-dose intramuscular IPV, however, flPV administration with BCG needle and syringe (BCG NS) is technically difficult. We compared immune response after one flPV dose administered with BCG NS to administration with intradermal devices, referred to as Device A and B;and assessed feasibility of conducting a door-to-door vaccination campaign with fIPV. In Phase I, 452 children 6-12 months old from Karachi were randomized to receive one fIPV dose either with BCG NS, Device A or Device B in a health facility. Immune response was defined as seroconversion or fourfold rise in polio neutralizing antibody titer 28 days after fIPV among children whose baseline titer <= 362. In Phase II, fIPV was administered during one-day door-to-door campaign to assess programmatic feasibility by evaluating vaccinators' experience. For all three poliovirus (PV) serotypes, the immune response after BCG NS and Device A was similar, however it was lower with Device B (34/44 (77%), 31/45 (69%), 16/30 (53%) respectively for PV1;53/78 (68%), 61/83 (74%), 42/80 (53%) for PV2;and;58/76 (76%), 56/80 (70%), 43/77 (56%) for PV3;p < 0.05 for all three serotypes). Vaccinators reported problems filling Device B in both Phases;no other operational challenges were reported during Phase II. Use of flPV offers a dose saving alternative to full-dose IPV. (C) 2017 The Authors. Published by Elsevier Ltd.

关键词： POLIOVIRUS   ORAL vaccines   VIRAL vaccines   VIROLOGY   VACCINATION  

摘要： The Global Polio Eradication Initiative (GPEI) has made substantial progress since its launch in 1988; only 37 wild poliovirus type 1 (WPV1) cases were detected in 2016, the lowest annual count ever. Wild poliovirus type 3 has not been detected since November 2012, and wild poliovirus type 2 was officially declared eradicated in September 2015. This success is attributable to the wide use of live oral poliovirus vaccines (OPVs). Since 2001, numerous outbreaks were caused by the emergence of genetically divergent vaccine-derived polioviruses (VDPVs) whose genetic drift from the parental OPV strains indicates prolonged replication or circulation (1). In 2015, circulating VDPV type 2 (cVDPV2) outbreaks were detected in five countries worldwide (Nigeria, Pakistan, Guinea, Burma, and South Sudan), and VDPV2 single events were reported in 22 countries. These events prompted the GPEI to withdraw the type 2 component (Sabin2) of trivalent OPV (tOPV) in a globally coordinated, synchronized manner in April 2016 (2,3), at which time all OPV-using countries switched to using bivalent OPV (bOPV), containing Sabin types 1 and 3. This report details for the first time the virologic tracking of elimination of a live vaccine that has been withdrawn from routine and mass immunization systems worldwide (3). To secure elimination, further monitoring is warranted to detect any use of tOPV or monovalent OPV type 2 (mOPV2).

关键词： Fractional inactivated polio vaccine   Inactivated polio vaccine   Priming   Polio immunogenicity  

摘要： Introduction: The polio eradication endgame strategic plan calls for the sequential removal of Sabin polio virus serotypes from the trivalent oral poliovirus vaccine (tOPV), starting with type 2, and the introduction of >= I dose of inactivated poliovirus vaccine (IPV), to maintain an immunity base against poliovirus type 2. The global removal of oral poliovirus type 2 was successfully implemented in May 2016. However, IPV supply constraints has prevented introduction in 21 countries and led to complete stock-out in >20 countries. Methods: We conducted a literature review and contacted corresponding authors of recent studies with fractional-dose IPV (flPV), one-fifth of intramuscular dose administered intradermally, to conduct additional type 2 immunogenicity analyses of two flPV doses compared with one full-dose IPV. Results: Four studies were identified that assessed immunogenicity of two flPV doses compared to one full-dose IPV. Two fractional doses are more immunogenic than 1 full-dose, with type 2 seroconversion rates improving between absolute 19-42% (median: 37%, p < 0.001) and relative increase of 53-125% (median: 82%), and antibody titer to type 2 increasing by 2-32-fold (median: 10-fold). Early age of administration and shorter intervals between doses were associated with lower immunogenicity. Discussion: Overall, two flPV doses are more immunogenic than a single full-dose, associated with significantly increased seroconversion rates and antibody titers. Two flPV doses together use two-fifth of the vaccine compared to one full-dose IPV. In response to the current IPV shortage, a schedule of two flPV doses at ages 6 and 14 weeks has been endorsed by technical oversight committees and has been introduced in some affected countries. (C) 2017 Published by Elsevier Ltd.

关键词： poliovirus   vaccine   Sabin strain   production  

摘要： The article discusses the promising prospect of next generation inactivated poliovirus vaccine and its impact to public health. Topics discussed include the current poliovirus vaccines available in the market such as the salk-inactivated poliovirus vaccine (IPV) designed to address polio infection in European countries, and offers brief background information on the development of sabin-IPV. The issue of IPV vaccine manufacturing is also presented.

关键词： Sabin-IPV   immune serum   cross neutralization   polioviruses  

摘要： Background. A Sabin strain-based inactivated poliomyelitis vaccine (Sabin-IPV) is the rational option for completely eradicating poliovirus transmission. The neutralizing capacity of Sabin-IPV immune serum to different strains of poliovirus is a key indicator of the clinical protective efficacy of this vaccine. Methods. Sera collected from 500 infants enrolled in a randomized, blinded, positive control, phase 2 clinical trial were randomly divided into 5 groups: Groups A, B, and C received high, medium, and low doses, respectively, of Sabin-IPV, while groups D and E received trivalent oral polio vaccine and Salk strain-based IPV, respectively, all on the same schedule. Immune sera were collected after the third dose of primary immunization, and tested in cross-neutralization assays against 19 poliovirus strains of all 3 types. Results. All immune sera from all 5 groups interacted with the 19 poliovirus strains with various titers and in a dose-dependent manner. One type 2 immunodeficiency-associated vaccine-derived poliovirus strain was not recognized by these immune sera. Conclusions. Sabin-IPV vaccine can induce protective antibodies against currently circulating and reference wild poliovirus strains and most vaccine-derived poliovirus strains, with rare exceptions. Clinical Trials Registration. NCT01056705

关键词： Inactivated polio vaccine   Mucosal delivery   Sublingual   Intranasal   Vaccines   Adjuvant  

摘要： Polio is on the brink of eradication. Improved inactivated polio vaccines (IPV) are needed towards complete eradication and for the use in the period thereafter. Vaccination via mucosal surfaces has important potential advantages over intramuscular injection using conventional needle and syringe, the currently used delivery method for IPV. One of them is the ability to induce both serum and mucosal immune responses: the latter may provide protection at the port of virus entry. The current study evaluated the possibilities of polio vaccination via mucosal surfaces using IPV based on attenuated Sabin strains. Mice received three immunizations with trivalent sIPV via intramuscular injection, or via the intranasal or sublingual route. The need of an adjuvant for the mucosal routes was investigated as well, by testing sIPV in combination with the mucosal adjuvant cholera toxin. Both intranasal and sublingual sIPV immunization induced systemic polio-specific serum IgG in mice that were functional as measured by poliovirus neutralization. Intranasal administration of sIPV plus adjuvant induced significant higher systemic poliovirus type 3 neutralizing antibody titers than sIPV delivered via the intramuscular route. Moreover, mucosal sIPV delivery elicited polio-specific IgA titers at different mucosal sites (IgA in saliva, fecal extracts and intestinal tissue) and IgA-producing B-cells in the spleen, where conventional intramuscular vaccination was unable to do so. However, it is likely that a mucosal adjuvant is required for sublingual vaccination. Further research on polio vaccination via sublingual mucosal route should include the search for safe and effective adjuvants, and the development of novel oral dosage forms that improve antigen uptake by oral mucosa, thereby increasing vaccine immunogenicity. This study indicates that both the intranasal and sublingual routes might be valuable approaches for use in routine vaccination or outbreak control in the period after co

关键词： 脊髓灰质炎后综合征   病理生理   综述  

摘要： 脊髓灰质炎后综合征(PPS)是患者急性感染脊髓灰质炎病毒,经过后遗症期后新发生的综合征。PPS发病率高,老年患者越来越多。PPS患者有累及肌肉的慢性神经源性损害,导致疲劳、疼痛、呼吸和睡眠障碍以及跌倒风险等,严重时影响健康状况和生活质量。PPS的发病机制有运动神经元过度负荷学说、脊髓灰质炎病毒持续存在学说等。PPS是一种相对稳定、缓慢进展的神经肌肉疾病。