Poliovirus Vaccine, Oral

脊髓灰质炎病毒疫苗 ,Oral
  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Journal Article
    自1988年全球根除脊髓灰质炎倡议启动以来,在阻断野生脊髓灰质炎病毒(WPV)在全球范围内的传播方面取得了实质性进展:全球根除WPV2型和3型分别于2015年和2019年获得认证。WPV1型的地方性传播仅在阿富汗和巴基斯坦继续。在2016年全球同步退出所有2型血清口服脊髓灰质炎病毒疫苗(OPVs)后,流行疫苗衍生的2型脊髓灰质炎病毒(cVDPV2)已经广泛爆发,这与人群对脊髓灰质炎病毒免疫力低的地区有关。自2017年以来,索马里官员发现了正在进行的cVDPV2传播。审查了索马里的脊髓灰质炎疫苗接种覆盖率和监测数据,以评估这种持续传播。在2017年1月至2024年3月期间,索马里官员在20个地区中的14个地区发现了39例cVDPV2病例。并传播到邻国埃塞俄比亚和肯尼亚。自2021年1月以来,在索马里开展了28项针对cVDPV2的补充免疫活动。该国某些地区的安全受到威胁,无法进行疫苗接种运动。在1,921名非脊髓灰质炎急性弛缓性麻痹儿童中,231(12%)没有通过常规免疫接种或SIA接受OPV剂量,其中95%来自中南部地区,60%的人生活在交通不便的地区。加强索马里的人道主义谈判措施,使安全受损地区的儿童能够接种疫苗,并加强无障碍地区的运动质量,将有助于阻断cVDPV2传播。
    Since the launch of the Global Polio Eradication Initiative in 1988, substantial progress has been made in the interruption of wild poliovirus (WPV) transmission worldwide: global eradication of WPV types 2 and 3 were certified in 2015 and 2019, respectively, and endemic transmission of WPV type 1 continues only in Afghanistan and Pakistan. After the synchronized global withdrawal of all serotype 2 oral poliovirus vaccines (OPVs) in 2016, widespread outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2) have occurred, which are linked to areas with low population immunity to poliovirus. Officials in Somalia have detected ongoing cVDPV2 transmission since 2017. Polio vaccination coverage and surveillance data for Somalia were reviewed to assess this persistent transmission. During January 2017-March 2024, officials in Somalia detected 39 cVDPV2 cases in 14 of 20 regions, and transmission has spread to neighboring Ethiopia and Kenya. Since January 2021, 28 supplementary immunization activities (SIAs) targeting cVDPV2 were conducted in Somalia. Some parts of the country are security-compromised and inaccessible for vaccination campaigns. Among 1,921 children with nonpolio acute flaccid paralysis, 231 (12%) had not received OPV doses through routine immunization or SIAs, 95% of whom were from the South-Central region, and 60% of whom lived in inaccessible districts. Enhancing humanitarian negotiation measures in Somalia to enable vaccination of children in security-compromised areas and strengthening campaign quality in accessible areas will help interrupt cVDPV2 transmission.
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  • 文章类型: Journal Article
    最近,开发了一种基于多重PCR的滴定(MPBT)测定法,用于同时测定口服脊髓灰质炎病毒疫苗(OPV)的所有三种萨宾菌株的感染滴度,以取代常规的CCID50测定法,这既费时费力。MPBT分析被证明是可重复的,健壮和敏感。常规和MPBT测定显示相似的结果和灵敏度。MPBT检测可以在两到三天内完成,而不是常规检测的十天。为了防止脊髓灰质炎病毒减毒疫苗株逆转为毒力,一本小说,遗传稳定的OPV(nOPV)是通过修饰OPV中使用的常规Sabin菌株的基因组而开发的。在这项工作中,我们评估了MPBT测定作为一种快速筛选工具,通过同时滴定三种nOPV菌株来支持三价nOPV(tnOPV)制剂开发,以确认所需的稳定性,用于选择主要的tnOPV配方候选。我们首先通过在同一板上滴定两个tnOPV样品(未稀释和三倍稀释)来评估MPBT测定区分0.5log10滴度差异的能力。一旦分析被证明是有区别的,然后,我们测试了在37°C下经历不同暴露时间的tnOPV药物产品(DP)的不同配方(未处理组和处理组:在37°C下2天和7天),和三个冻融(FT)循环。通过进行常规CCID50测定,最终确认了向下选择的候选制剂。比较未治疗组和治疗组的稳定性,并对前三名候选人进行FT稳定性测试。结果显示MPBT测定产生与常规测定相似的滴度。通过在同一板上测试两个三价样品,该测定可以区分测试的nOPV样品的滴度之间的0.5log10差异。此外,该测定能够检测具有不同制剂组成和在不同时间/温度条件和冷冻/解冻循环下的nOPV病毒的逐渐降解。我们发现,有三种tnOPV制剂在暴露于37℃2天后和三个FT循环后,满足小于0.5log10损失的稳定性标准,维持这些制剂中所有三种血清型的效力。MPBT测定在同一平板中滴定两个tnOPV批次(六个病毒)的能力使其更便宜,并为快速筛选提供了更高的通量。该测定检测到tnOPV的逐渐降解,并且成功地选择了tnOPV的最佳制剂。结果表明,MPBT方法可用作稳定性指示测定法,以评估nOPV的热稳定性。可用于疫苗生产过程中病毒滴度的快速测定,在临床试验中。MPBT测定可以自动化并应用于其他病毒,包括那些没有细胞病变效应的。
    Recently, a multiplex PCR-based titration (MPBT) assay was developed for simultaneous determination of infectious titers of all three Sabin strains of the oral poliovirus vaccine (OPV) to replace the conventional CCID50 assay, which is both time-consuming and laborious. The MPBT assay was shown to be reproducible, robust and sensitive. The conventional and MPBT assays showed similar results and sensitivity. The MPBT assay can be completed in two to three days, instead of ten days for the conventional assay. To prevent attenuated vaccine strains of poliovirus from reversion to virulence, a novel, genetically stable OPV (nOPV) was developed by modifying the genomes of conventional Sabin strains used in OPV. In this work, we evaluated the MPBT assay as a rapid screening tool to support trivalent nOPV (tnOPV) formulation development by simultaneous titration of the three nOPV strains to confirm stability as needed, for the selection of the lead tnOPV formulation candidate. We first assessed the ability of the MPBT assay to discriminate a 0.5 log10 titer difference by titrating the two tnOPV samples (undiluted and threefold-diluted) on the same plate. Once the assay was shown to be discriminating, we then tested different formulations of tnOPV drug products (DPs) that were subjected to different exposure times at 37 °C (untreated group and treated groups: 2 and 7 days at 37 °C), and to three freeze and thaw (FT) cycles. Final confirmation of the down selected formulation candidates was achieved by performing the conventional CCID50 assay, comparing the stability of untreated and treated groups and FT stability testing on the top three candidates. The results showed that the MPBT assay generates similar titers as the conventional assay. By testing two trivalent samples in the same plate, the assay can differentiate a 0.5 log10 difference between the titers of the tested nOPV samples. Also, the assay was able to detect the gradual degradation of nOPV viruses with different formulation compositions and under different time/temperature conditions and freeze/thaw cycles. We found that there were three tnOPV formulations which met the stability criteria of less than 0.5 log10 loss after 2 days\' exposure to 37 ℃ and after three FT cycles, maintaining the potency of all three serotypes in these formulations. The ability of the MPBT assay to titrate two tnOPV lots (six viruses) in the same plate makes it cheaper and gives it a higher throughput for rapid screening. The assay detected the gradual degradation of the tnOPV and was successful in the selection of optimal formulations for the tnOPV. The results demonstrated that the MPBT method can be used as a stability indicating assay to assess the thermal stability of the nOPV. It can be used for rapid virus titer determination during the vaccine manufacturing process, and in clinical trials. The MPBT assay can be automated and applied for other viruses, including those with no cytopathic effect.
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  • 文章类型: News
    2024年结束所有传输的目标可能会错过。
    2024 target of ending all transmission will likely be missed.
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  • 文章类型: Systematic Review
    疫苗相关的麻痹性脊髓灰质炎(VAPP)是口服脊髓灰质炎病毒疫苗(OPV)的罕见不良事件,特别影响免疫缺陷个体。
    本研究旨在(1)使用疫苗不良事件报告系统(VAERS)数据库评估OPV和VAPP之间的关联(2)通过对病例报告和病例系列的系统回顾,概述OPV接受者中与VAPP发生相关的患者特征和风险因素。使用VAERS的数据进行了不成比例的分析,包括1990年至2023年2月报告的不良事件。此外,我们使用PubMed对病例报告和病例系列进行了系统审查,Scopus,和Embase数据库。
    VAERS数据显示,在1,739,903个OPV相关不良事件中,有130个VAPP报告,与2010年报告的最强协会。对37项研究的系统评价强调了疫苗接种后2个月至4年内VAPP的发生。通常伴有急性弛缓性麻痹。免疫缺陷和肛周脓肿是主要的危险因素。在37项纳入的研究中,27使用WHO-AEFI因果关系评估工具显示VAPP与OPV的因果关系一致。
    该研究强调了VAPP的严重性,并强调了其与OPV的关联,确定免疫缺陷是VAPP表现的重要因素。
    UNASSIGNED: Vaccine-associated paralytic poliomyelitis (VAPP) is a rare adverse event of oral poliovirus vaccines (OPV), particularly affecting immunodeficient individuals.
    UNASSIGNED: This study aimed to (1) Assess the association between OPV and VAPP using Vaccine Adverse Event Reporting System (VAERS) database (2) Outline patient characteristics and risk factors associated with the occurrence of VAPP in OPV recipients through a systematic review of case reports and case series. A disproportionality analysis was conducted using the data from VAERS, encompassing adverse events reported from 1990 till February 2023. Additionally, we conducted a systematic review of case reports and case series using PubMed, Scopus, and Embase databases.
    UNASSIGNED: The VAERS data revealed 130 VAPP reports among 1,739,903 OPV linked adverse events, with year 2010 reporting the strongest association. The systematic review of 37 studies highlighted VAPP occurrence within 2 months to 4 years post-vaccination, typically with acute flaccid paralysis. Immunodeficiency and perianal abscess emerged as major risk factors. Out of the 37 included studies, 27 showed consistent causal association of VAPP with OPV using WHO-AEFI causality assessment tool.
    UNASSIGNED: The study emphasized the seriousness of VAPP and highlights its association with OPV, identifying immunodeficiency as a prominent contributor to VAPP manifestation.
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  • 文章类型: Journal Article
    背景:为了评估中国目前的主要脊髓灰质炎疫苗接种时间表的免疫原性,并将其与使用Sabin或Salk株IPV的替代时间表进行比较(sIPV,wIPV)。
    方法:在重庆的四个地点进行了横断面调查,中国,60-89天的健康婴儿被方便地招募,并根据他们接受的初级脊髓灰质炎疫苗接种时间表分为四组(2sIPV+bOPV,2wIPV+bOPV,3sIPV,和3wIPV)。末次给药后比较针对脊髓灰质炎病毒血清型(1、2和3型)的血清保护和中和抗体滴度。
    结果:有408名婴儿完成了方案。在所有组中,观察到的针对脊髓灰质炎病毒1、2和3型的血清阳性均超过96%。与“2IPVbOPV”组相比,仅IPV组对2型脊髓灰质炎病毒的抗体滴度(GMT)更高(中位数:192,QR:96-384,P<0.05)。而“2IPV+bOPV”组诱导的抗脊髓灰质炎病毒1型(中位数:2048,QR:768-2048,P<0.05)和3型(中位数:2048,QR:512-2048,P<0.05)的抗体滴度明显高于仅IPV组。
    结论:我们的研究结果证明,两剂IPV和一剂bOPV是目前中国最好的脊髓灰质炎常规免疫方案。
    BACKGROUND: To assess the immunogenicity of the current primary polio vaccination schedule in China and compare it with alternative schedules using Sabin or Salk-strain IPV (sIPV, wIPV).
    METHODS: A cross-sectional investigation was conducted at four sites in Chongqing, China, healthy infants aged 60-89 days were conveniently recruited and divided into four groups according to their received primary polio vaccination schedules (2sIPV + bOPV, 2wIPV + bOPV, 3sIPV, and 3wIPV). The sero-protection and neutralizing antibody titers against poliovirus serotypes (type 1, 2, and 3) were compared after the last dose.
    RESULTS: There were 408 infants completed the protocol. The observed seropositivity was more than 96% against poliovirus types 1, 2, and 3 in all groups. IPV-only groups induced higher antibody titers(GMT) against poliovirus type 2 (Median:192, QR: 96-384, P<0.05) than the \"2IPV + bOPV\" group. While the \"2IPV + bOPV\" group induced significantly higher antibody titers against poliovirus type 1 (Median:2048, QR: 768-2048, P<0.05)and type 3 (Median:2048, QR: 512-2048, P<0.05) than the IPV-only group.
    CONCLUSIONS: Our findings have proved that the two doses of IPV with one dose of bOPV is currently the best polio routine immunization schedule in China.
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  • 文章类型: Journal Article
    1988年,脊髓灰质炎(脊髓灰质炎)成为根除的目标。全球努力已经根除了三种野生脊髓灰质炎病毒(WPV)血清型中的两种(2型和3型),只有WPV类型1(WPV1)仍然是地方性的,只有在阿富汗和巴基斯坦。这份报告描述了全球脊髓灰质炎免疫接种,监视活动,2022年1月至2023年12月期间的脊髓灰质炎病毒流行病学,使用截至2024年4月10日的最新数据。2023年,阿富汗和巴基斯坦确定了12例WPV1脊髓灰质炎病例,2022年为22。通过对阿富汗和巴基斯坦13个省的污水样本中的脊髓灰质炎病毒进行系统检测(环境监测),发现了WPV1传播,与2022年的七个省份相比。由循环疫苗衍生的脊髓灰质炎病毒(cVDPV;已恢复神经毒力的循环疫苗病毒株)引起的脊髓灰质炎病例数量从2022年的881例减少到2023年的524例;2023年,在32个国家/地区发生了cVDPV暴发(定义为有传播证据的cVDPV病例或至少两个阳性环境监测分离株),其中8个在2022年没有发生cVDPV尽管从2022年开始麻痹性脊髓灰质炎病例有所减少,但在2023年,cVDPV病例和WPV1病例(在有地方性传播的国家)在地理上更加普遍。在WPV1传播流行的国家和地区,继续努力为持续失踪的儿童接种疫苗,加强脊髓灰质炎病毒传播高危国家的常规免疫计划,并提供更有效的cVDPV疫情应对措施对于进一步在全球根除脊髓灰质炎方面取得进展是必要的。
    In 1988, poliomyelitis (polio) was targeted for eradication. Global efforts have led to the eradication of two of the three wild poliovirus (WPV) serotypes (types 2 and 3), with only WPV type 1 (WPV1) remaining endemic, and only in Afghanistan and Pakistan. This report describes global polio immunization, surveillance activities, and poliovirus epidemiology during January 2022-December 2023, using data current as of April 10, 2024. In 2023, Afghanistan and Pakistan identified 12 total WPV1 polio cases, compared with 22 in 2022. WPV1 transmission was detected through systematic testing for poliovirus in sewage samples (environmental surveillance) in 13 provinces in Afghanistan and Pakistan, compared with seven provinces in 2022. The number of polio cases caused by circulating vaccine-derived polioviruses (cVDPVs; circulating vaccine virus strains that have reverted to neurovirulence) decreased from 881 in 2022 to 524 in 2023; cVDPV outbreaks (defined as either a cVDPV case with evidence of circulation or at least two positive environmental surveillance isolates) occurred in 32 countries in 2023, including eight that did not experience a cVDPV outbreak in 2022. Despite reductions in paralytic polio cases from 2022, cVDPV cases and WPV1 cases (in countries with endemic transmission) were more geographically widespread in 2023. Renewed efforts to vaccinate persistently missed children in countries and territories where WPV1 transmission is endemic, strengthen routine immunization programs in countries at high risk for poliovirus transmission, and provide more effective cVDPV outbreak responses are necessary to further progress toward global polio eradication.
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  • 文章类型: News
    评估草案将2016年改变口服疫苗的决定称为“失败”。
    Draft evaluation calls 2016 decision to change oral vaccines a \"failure\".
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  • 文章类型: Journal Article
    1964年春季,由AlbertSabin开发的口服疫苗在意大利开始接种脊髓灰质炎疫苗。脊髓灰质炎在世界和意大利都很受欢迎。因此,1957年至1958年初,意大利儿童开始接受“索尔克疫苗”,尽管结果并不特别令人信服。1960年7月,国际科学界能够验证萨宾疫苗大规模测试的数据。很明显,OPV,可以防止病毒繁殖,从而提供更大的保护并确定疾病的根除。1960年,仅苏联就有超过7000万人接受了口服疫苗,美国的大规模疫苗接种将于1961年3月开始。然而,在意大利,没有类似的倡议;只是后来新疫苗被接受,但一开始就没有强制性。作为委员会报告的结果,“政治”疫苗的注册,该疫苗于1962年9月获得授权,但直到1963年11月才获得授权。1964年初,“Polioral”的生产开始,该产品开始销售,并于1964年3月1日在意大利开始使用“Sabin抗脊髓灰质炎疫苗”进行抗脊髓灰质炎疫苗接种。这份手稿重点关注了一个关于公共卫生历史延误的关键问题,它指出,萨宾脊髓灰质炎疫苗的制备和推广表明,关于健康治疗的决定,特别是疫苗接种运动,必须完全基于临床研究的结果和科学界的独立评估。这一过程确保了人们对疫苗的信任,充分保护公众健康和公民福祉。
    In the spring of 1964, polio vaccination with the oral vaccine developed by Albert Sabin began in Italy. Polio was feared in the world and in Italy. Thus, between 1957 and the beginning of 1958, Italian children began receiving the \"Salk vaccine\", though the results were not particularly convincing. In July 1960, the international scientific community was able to verify the data from the mass testing of the Sabin vaccine. It became clear that the OPV, could prevent the virus from multiplying, thereby providing greater protection and determining the eradication of the disease. In 1960 over 70 million people in the USSR alone had already received the oral vaccine and mass vaccination in the USA would start in March 1961. However, in Italy there was no similar initiative; only later the new vaccine was accepted but was not made compulsory at the beginning. As a result of the commission\'s report, registration of the \"Polioral\" vaccine, was authorized in September 1962 but the sale of the vaccine was not authorized until November 1963. At the beginning of 1964, the production of \"Polioral\" started and the product was marketed and on the 1 st of March 1964, anti-polio vaccination with the \"Sabin anti-polio vaccine\" also began in Italy. This manuscript focuses on a crucial issue about a historical delay for public health and it points out as the preparation and diffusion of the Sabin polio vaccine demonstrates that decisions regarding health treatments, and specifically vaccination campaigns, must be based exclusively on the results of clinical studies and on independent evaluation by the scientific community. This process ensures trust in vaccines, adequate protection of public health andcitizens\' well-being.
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  • 文章类型: Journal Article
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