北京市二价脊髓灰质炎减毒活疫苗引入前后不同基础免疫程序效果和疫苗效价分析

目的了解二价脊髓灰质炎(脊灰)减毒活疫苗(b OPV)引入前后北京市2014年和2016年不同基础免疫程序免疫效果和疫苗效价。方法 2014年和2016年脊灰疫苗基础免疫程序分别为3剂三价脊灰减毒活疫苗(t OPV)全程免疫和1剂脊灰灭活疫苗(IPV)与2剂二价脊灰减毒活疫苗(b OPV)序贯免疫,分别在北京市两个区选择完成基础免疫后4-8周的婴儿,采集血标本以检测脊灰病毒中和抗体,同时采集不同疫苗储运环节的疫苗标本以检测疫苗效价。结果 2014年和2016年分别调查儿童72人和68人。2014年基础免疫后Ⅰ、Ⅲ型脊灰病毒中和抗体阳性率分别为98.61%和100%,抗体滴度(1∶)[中位数(四分位数间距)]分别为1 536(1 024-1 536)、1 536(512-1 536);2016年基础免疫后Ⅰ型、Ⅲ型脊灰病毒中和抗体阳性率均为100%,抗体滴度(1∶)分别为1 024(512-1 536)、1 536(1 024-1 536)。2014年和2016年Ⅰ、Ⅲ型脊灰病毒中和抗体分布均有显著性差异(Ⅰ型:χ2=8.77,P=0.038;Ⅲ型:χ2=16.76,P=0.001)。2014年t OPV的平均效价为6.1±0.1Lg CCID50/剂,2016年b OPV的平均效价为6.9±0.2Lg CCID50/剂(t=-7.76,P0.001)。结论新疫苗b OPV引入后,IPV-b OPV序贯免疫程序的基础免疫效果与引入前的t OPV全程和IPV-t OPV序贯免疫程序效果一样好;疫苗储运各环节疫苗效价均合格,冷链运转良好。     

我国实施脊灰疫苗免疫新策

正日前,国家卫生计生委公布,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,停用三价脊灰减毒活疫苗(t OPV),由二价脊灰减毒活疫苗(b OPV)替代,并将脊灰灭活疫苗(IPV)纳入国家免疫规划。这次脊灰疫苗免疫策略的调整,是全球消灭脊灰的统一行动,也是我国脊灰防控工作的实际需要。     

脊髓灰质炎流行现状及控制对策

脊髓灰质炎（脊灰）是由脊灰病毒引起的急性肠道传染病,人是脊灰病毒的唯一宿主。1988年世界卫生组织提出2000年在全球范围内消灭脊灰,目前仅有阿富汗、印度、尼日利亚、巴基斯坦4个国家有脊灰野毒株本土病例报告。随着无脊灰目标的逐渐实现,口服脊髓灰质炎减毒活疫苗（OPV）的缺点逐渐凸现,如OPV在热带地区效力低,可引起疫苗相关麻痹脊灰（VAPP）及免疫抑制者长期排毒等,因此,继续使用OPV不能最终消灭脊灰。1996年,美国免疫实践咨询委员会推荐通过先使用脊灰灭活疫苗（IPV）再使用OPV的连续接种程序来增加IPV的使用,IPV的大量使用消除了活疫苗病毒的散播,也消除了VAPP。2008年,我国提出脊灰疫苗的免疫策略可借鉴国外成功的经验,逐步采用IPV替代OPV。目前已有学者进行了前瞻性研究,证实在中国以IPV替代OPV是可行的。     

三价口服脊髓灰质炎减毒活疫苗效价监测分析

基础免疫工作是维护儿童健康成长,提高全民身体素质的重要途径之一。口服脊灰减毒活疫苗(OPV),是脊灰免疫的首选疫苗。为了解疫苗在储存、运输过程中各环节的效价变化,减少无效接种,提高免疫成功率,对疫苗效价进行监测是很有必要的。现将吉林省1996～1999年监测结果报告如下:     

预防疫苗衍生脊髓灰质炎病毒的传播

自1988年世界卫生组织（WHO）提出在全球范围内消灭脊髓灰质炎（脊灰）的目标后,世界各国大力开展口服脊灰减毒活疫苗（OPV）的计划免疫,脊灰发病率明显下降。目前美洲、欧洲和西太平洋地区已消灭了本土脊灰野病毒的传播。本病的流行国家已由1988年的125个降至2004年的6个。     

中国脊髓灰质炎疫苗使用历史回顾及免疫策略调整建议

在消灭脊髓灰质炎（脊灰）过程中,脊灰疫苗发挥了重要作用。口服脊灰减毒活疫苗（Oral Poliomyelitis Attenuated Live Vaccine,OPV）是一种安全有效的疫苗,中国于20世纪60年代推广使用OPV,常规免疫接种率逐步提高到〉90％。从1990年开始,部分省（自治区、直辖市）开展了OPV补充免疫活动（Supplementary Immunization Activity,SIA）;1993～2000年,开展消灭脊灰的国家免疫日活动,中国所在的世界卫生组织（World Health Organization,WHO）西太平洋区于2000年实现无脊灰的目标,继续在适龄儿童中加强OPV常规免疫和开展SIA。根据WHO制定的（（2013—2018年消灭脊灰终结战略计划》,2015年所有国家要引进至少1剂灭活脊灰病毒疫苗（Inactivated Poliovirus Vaccine,IPV）,2016年中期使用二价OPV（I＋Ⅲ型）,2018年停用OPV。为确保OPV成功转换IPV,中国应建立部门间协作机制,加快国产IPV研发生产进程,组织开展OPV和IPV转换的相关研究。     

北海市辖区17年口服脊髓灰质炎疫苗强化免疫效果评价

目的对北海市辖区连续17年34轮进行脊髓灰质炎（脊灰）减毒活疫苗（OPV）强化免疫活动实施效果评价。方法利用该市1991—2008年1月的3岁以下儿童OPV强化免疫以及人群脊灰中和抗体水平、脊灰发病监测等资料进行描述性分析。结果该市17年OPV的强化免疫合计接种率97．9％；零剂次儿童占3岁以下总儿童的3．9％；1-59岁健康人群脊灰Ⅰ、Ⅱ、Ⅲ型中和抗体阳性率分别为99.0％、99．5％、97．5％，抗体几何平均滴度（GMT）分别为1：115．7、1：97．2、1：32．6。病毒学监测已连续15年无脊灰野病毒病例发生。结论该市辖区17年OPV的强化免疫效果显著，人群对脊灰已形成免疫屏障，维持了无脊灰状态。     

全球发现的疫苗衍生脊髓灰质炎病毒（2012年7月～2013年12月）

1988年,世界卫生大会确立了全球消灭脊髓灰质炎（脊灰）的目标。在消灭脊灰所做的努力中,一个主要工具是口服脊灰减毒活疫苗（Oral Poliomyelitis Attenuated Live Vaccine,OPV）,这种疫苗价格不高,可以由受过培训的志愿者进行喂服。可能需要几剂OPV才能为受种者提供完全免疫,这样能通过持久的体液免疫提供长期的保护作用以预防麻痹型脊灰。     

使用脊髓灰质炎灭活疫苗的必要性及存在的问题

口服脊髓灰质炎（脊灰）减毒活疫苗（Oral Poliomyelitis Attenuated Live Vaccine,OPV）作为全球消灭脊灰的主要手段,在以发展中国家为中心的脊灰流行地区广泛使用。OPV有很多优点,其有效性、安全性、经济性都很显著,但同时也存在由于OPV本身的病毒学特性所引起的各种问题。因此,使用脊灰灭活疫苗（Inactivated Poliovirus Vaccine,IPV）替代OPV的必要性逐渐增加。现就替代OPV的疫苗,尤其是来自减毒的脊灰病毒的IPV,在日本及发展中国家使用的可能性和存在的问题加以论述。     

全球使用脊髓灰质炎病毒灭活疫苗的经验

口服脊髓灰质炎（脊灰）减毒活疫苗（Oral Poliomylitis AttenuateLive Vaccine,OPV）是全球消灭脊灰的战略,OPV已大幅度降低全球脊灰的发病率。然而,由于疫苗相关麻痹型脊灰（Vaccine Associated Paralytic Poliomyelitis,VAPP）和疫苗衍生脊灰病毒（Vac—cine-derived Poliovirus,VDPV）风险,今后必须停止0PV的使用,以彻底根除脊灰。     

Polio eradication in India: some observations

In 1988, the World Health Assembly passed resolution WHA 41.28, which committed the World Health Organization (WHO) to the global eradication of poliomyelitis by the year 2000. In spite of the combined efforts by UNICEF, National Polio Surveillance Project (NPSP), Indian Academy of Pediatrics (IAP) and Rotary International, Polio Free India is still a distant dream.Though oral polio vaccine has succeeded in polio eradication from many countries but there is high incidence of vaccine failure in India.Oral polio vaccine (OPV) has failed to provide full protection to many children who have developed paralytic polio even after taking 10 or more doses of OPV. In some children, OPV has caused paralysis-vaccine associated paralytic polio (VAPP). Number of children developing polio due to vaccine is high and on increase. Reasons for this could be that even immunocompromised children are being administered OPVbecause IPV is not available. Vaccine failure has exaggerated the problem of VAPP. No efforts have been made to find the causes for high incidence of vaccine failure and VAPP.     

山东省部分地区跛行调查报告

对山东省4个县进行了一次跛行调查,这4县在1986~1988年持续有脊髓灰质炎(脊灰)流行。调查结果表明,从1974年到1989年共发生了251例脊灰病人,其中上报了138例。人群中15岁以下年龄组脊灰现患率为0.486‰。调查结果还表明,在农村,脊灰仍为儿童致残的主要原因,脊灰病例占所有麻痹病例的48%。麻痹的主要肢体为下肢,占90%。分析脊灰病例与非脊灰病例的服苗史发现,两组差别有高度显著性,90%的脊灰病例无服苗史或无完全服苗史。未服苗的主要原因为缺乏认识。另外,我们也分析了多胎因素,但未发现有显著性。     

Polio: The Disease that Reemerged after Six Years in Ethiopia

BackgroundPolio is a disabling and potentially deadly disease caused by a wild poliovirus and vaccine-derived poliovirus. The purpose of this review is to discuss the current situation of polio in Ethiopia.MethodRelevant scientific articles on Polio were searched from different data bases and websites.ResultsThe first wild poliovirus in Ethiopia was detected in 1999, followed by detection of few cases in 2000 and 2001. No wild poliovirus was detected in Ethiopia for the next 3 years (2001–2003). However, the disease resurged again in the country between 2004 and 2008 due to challenge to provide sufficient oral poliovirus vaccine coverage, migration and cross border economic activities and lack of good acute flaccid paralysis surveillance. After almost 5 years with no wild polio virus, Ethiopia again affected by polio outbreak importation in 2013. However, due to multiple supplementary immunization activities campaigns of improved quality and enhanced surveillance, the outbreak was eventually successfully interrupted within 6 months of confirmation. The most recent emergence of polio in Ethiopia has seen in this year (2020) six years after the country documented zero polio cases since 2014. The cause of the resurgence of the disease is circulating vaccine derived polio virus-2. Currently, Ethiopia has been conducting outbreak response by declaring Mop-up campaigns since September 2020.ConclusionsTherefore, it can be recommended that: - 1. The country has to completely shift from oral polio virus vaccine to inactivated polio vaccine so that the risk of vaccine derived polio will be diminished; 2. Ethiopia has to strengthen the mop up campaign that it has started in September 2020 following the reemergence of the disease in the country; 3. Ethiopia has to strengthen surveillance for acute flaccid paralysis in order to rapidly detect any new virus importation and to facilitate a rapid response.     

新型Ⅱ型口服脊髓灰质炎减毒活疫苗研究进展

全球消灭脊髓灰质炎行动(GPEI)于2016年4月调整脊髓灰质炎疫苗免疫接种战略,将三价口服脊髓灰质炎疫苗(tOPV)转换为二价口服脊髓灰质炎疫苗(bOPV),并在全球全面撤出Ⅱ型口服脊髓灰质炎减毒活疫苗(OPVⅡ)。然而在OPVⅡ撤出以后,亚洲和非洲多地暴发Ⅱ型循环疫苗衍生脊髓灰质炎病毒(cVDPVⅡ)。为了彻底消灭脊髓灰质炎病毒,GPEI于2010年启动研发新型Ⅱ型口服脊髓灰质炎减毒活疫苗(nOPVⅡ),并于近年开始考虑是否有必要重启OPV。本文概述了OPVⅡ撤出前后cVDPVⅡ的流行病学情况,影响OPV重启的相关因素以及nOPVⅡ相关研究进展。     

Reducing resistance to polio immunisation with free health camps and Bluetooth messaging: An update from Kaduna,Northern, Nigeria

Since 1997, the Global Polio Eradication Initiative has sponsored regular door-to-door polio immunisation campaigns in northern Nigeria. On 30 July 2015, the country was finally declared poliofree, a hard won success. At various times, polio eradication has been threatened by rumours and community tensions. For example, in 2003, local Imams, traditional leaders and politicians declared a polio campaign boycott, due to the concerns about the safety of the polio vaccine. Although the campaigns resumed in 2004, many parents continued to refuse vaccination because of the persistence of rumours of vaccine contamination, and anger about the poor state of health services for conditions other than polio. To address this, UNICEF and Nigerian Government partners piloted two interventions: (1) mobile ‘health camps’ to provide ambulatory care for conditions other than polio and (2) an audiovisual clip about vaccine safety and other health issues, shareable on multimedia mobile phones via Bluetooth pairing. The mobile phone survey found that Bluetooth compatible messages could rapidly spread behavioural health messages in low-literacy communities. The health camps roughly doubled polio vaccine uptake in the urban ward where it was piloted. This suggests that polio eradication would have been accelerated by improving primary health care services.     

Imported vaccine-associated paralytic poliomyelitis--United States, 2005

Paralytic poliomyelitis is rare in the United States because of the success of universal childhood immunization and the Global Polio Eradication Initiative. Poliovirus vaccine was introduced in the 1950s. Since then, the United States has eliminated indigenous wild poliovirus transmission, controlled imported wild poliovirus cases, and, through a vaccine policy change (i.e., from live, attenuated oral polio vaccine [OPV] to inactivated polio vaccine [IPV]), eliminated vaccine-associated paralytic polio (VAPP) cases. The most recent VAPP case occurred in 1999. The primary risk for paralytic polio for U.S. residents is through travel to countries where polio remains endemic or where polio outbreaks are occurring. This report describes the first known occurrence of imported VAPP in an unvaccinated U.S. adult who traveled abroad, where she likely was exposed through contact with an infant recently vaccinated with OPV. This case highlights the previously unrecognized risk for paralytic polio among unvaccinated persons exposed to OPV during travel abroad.     

江苏省急性弛缓性麻痹病例病原学监测

目的掌握江苏省脊灰和非脊灰肠道病毒血清型别以及脊灰病毒的基因型别,确认其是否野毒株,为维持无脊灰状态提供病毒学依据。方法对2005-2013年江苏省急性弛缓性麻痹病例(AFP)监测数据进行分析,由国家脊灰实验室对脊灰病毒株进行型内鉴定。结果 2005-2013年江苏省脊灰实验室共收到AFP病例粪便标本2 413份,AFP病例接触者粪便标本252份。AFP病例中分离到脊灰病毒86株,年均分离率3.56%,分离到非脊灰肠道病毒163例,年均分离率6.76%;AFP病例接触者中分离出脊灰病毒12例,年均分离率4.76%,分离出非脊灰肠道病毒22例,年均分离率8.73%。未发现脊灰野病毒和疫苗衍生脊灰病毒。结论江苏省脊灰实验室为WHO和国家脊灰实验室盲样标本能力验证和现场认证评估合格实验室,细胞系敏感性均达到WHO要求,本监测数据可为继续保持无脊灰状态提供病毒学依据。     

Report of the Australian National Polio Reference Laboratory. 1 July to 31 December 1999

Since 1994, as part of the global eradication of poliomyelitis, the Australian National Polio Reference Laboratory (NPRL) at the Victorian Infectious Diseases Reference Laboratory (VIDRL) has been responsible for virological testing to confirm the absence of poliomyelitis in Australia. Samples from patients with acute flaccid paralysis are transported to VIDRL for viral culture. Polio and enteroviruses are referred for intratypic differentiation as wild or Sabin (vaccine) strains. A total of 23 faecal specimens from 17 patients were processed for enterovirus culture in the period 1 July to 31 December 1999. Since 1995, 1,078 enterovirus isolates from six states have been tested for the presence of wild poliovirus. To date, 562 strains were confirmed as Sabin vaccine-like, one non Sabin-like strain was identical with a laboratory control virus and the other strains were non-polio enteroviruses or other viruses. A World Health Organization (WHO) workshop in diagnostic polio polymerase chain reaction techniques was held at VIDRL in November 1999. The laboratory was reaccredited as a regional polio reference laboratory for the WHO Western Pacific region and a national laboratory for Australia, the Pacific Island countries and Brunei Darussalam. Planning is proceeding for the polio-free certification and containment of laboratory stocks of wild poliovirus infectious materials in Australia.     

sIPV process development for costs reduction

Polio is expected to be eradicated within only a few years from now. Upon polio eradication, the use of oral polio vaccines, which can cause circulating and virulent vaccine derived polio viruses, will be stopped. From this moment onwards, inactivated polio vaccines (IPV) will be used for worldwide vaccination against polio. An increased demand for IPV is thus anticipated. As a result, process development studies regarding the IPV production process, developed in the 1960s, have intensified. Studies on yield optimization aiming at costs reduction as well as the use of alternative polio viruses, which are more biosafe for manufacturing, are actual. Here our strategy to setup a new IPV production process using attenuated Sabin polio virus strains is presented. Moreover, aspects on reduction of the costs of goods and the impact of process optimization on sIPV costs are reviewed.