Poliovirus

脊髓灰质炎病毒
  • 文章类型: Journal Article
    由于温度的特殊性和污染菌群的多样性,有效的消毒方法在食品的冷链运输过程中至关重要。这项研究的目的是研究不同消毒剂在-20°C下对各种真菌的消毒效果,以实现对各种细菌种群的准确消毒。过氧乙酸,过氧化氢,选择硫酸氢钾作为低温消毒剂,并与防冻剂结合使用。这些低温消毒剂对病原体的消毒效果,如枯草芽孢杆菌黑色变种孢子(ATCC9372),金黄色葡萄球菌(ATCC6538),白色念珠菌(ATCC10231),大肠杆菌(8099),和脊髓灰质炎病毒(PV-1)依次通过杀菌和病毒灭活实验进行验证。经过规定时间的消毒,使用中和剂停止消毒过程。研究表明,不同消毒剂在低温消毒过程中表现出选择性效果。过氧乙酸,过氧化氢,和过硫酸钾适用于细菌繁殖体的低温环境消毒,病毒,和真菌污染物。然而,对于对孢子有很强抵抗力的微生物,应选择基于过氧乙酸的低温消毒剂进行有效的消毒处理。我们的结果为将来选择合适的消毒剂对各种潜在病原体进行消毒提供了有价值的参考。
    Effective disinfection methods are crucial in the cold chain transportation process of food due to the specificity of temperature and the diversity of contaminated flora. The objective of this study was to investigate the sanitizing effect of different disinfectants on various fungi at - 20 °C to achieve accurate disinfection of diverse bacterial populations. Peracetic acid, hydrogen peroxide, and potassium bisulfate were selected as low-temperature disinfectants and were combined with antifreeze. The sanitizing effect of these cryogenic disinfectants on pathogens such as Bacillus subtilis black variant spores (ATCC9372), Staphylococcus aureus (ATCC 6538), Candida albicans (ATCC 10231), Escherichia coli (8099), and poliovirus (PV-1) was sequentially verified by bactericidal and virus inactivation experiments. After a specified time of disinfection, a neutralizing agent was used to halt the sanitizing process. The study demonstrates that different disinfectants exhibit selective effects during the low-temperature disinfection process. Peracetic acid, hydrogen peroxide, and potassium monopersulfate are suitable for the low-temperature environmental disinfection of bacterial propagules, viruses, and fungal contaminants. However, for microorganisms with strong resistance to spores, a low-temperature disinfectant based on peracetic acid should be chosen for effective disinfection treatment. Our results provide a valuable reference for selecting appropriate disinfectants to sanitize various potential pathogens in the future.
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  • 文章类型: Letter
    暂无摘要。
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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: Clinical Trial, Phase III
    这个开放标签,随机化,中国的3期研究(V260-074;NCT04481191)评估了同时和交错给药三种剂量口服的免疫原性和安全性,活,五价轮状病毒疫苗(RV5)和三个剂量的肌肉,400名健康婴儿的脊髓灰质炎灭活疫苗(IPV)。主要目标是伴随与交错使用组中的中和抗体(nAb)反应的非劣效性。在基线和剂量3(PD3)后1个月测量抗体应答。在伴随使用或交错使用组的研究疫苗接种后,父母/法定监护人记录了30或15天的不良事件。分别。在PD3时,>98%的参与者血清转化为所有三种脊髓灰质炎病毒类型,并且主要目标得到满足,因为nAb血清转换百分比组间差异的双侧95%CI的下限范围为-4.3%至-1.6%,对于所有类型的脊髓灰质炎病毒,p<.001。在PD3时,伴随使用组和交错使用组中对1、2和3型脊髓灰质炎病毒的nAb反应的几何平均滴度(GMT)具有可比性;对于所有脊髓灰质炎病毒类型,100%的参与者的nAb滴度≥1:8和≥1:64。抗轮状病毒血清型特异性IgAGMT和疫苗接种后滴度比基线升高≥3倍的参与者在组间具有可比性。两组患者对RV5和IPV的给药耐受性良好,安全性相当。伴随使用组IPV的免疫原性不劣于交错使用组,两组RV5均具有免疫原性。没有发现安全问题。这些数据支持在健康的中国婴儿中同时使用RV5和IPV。
    This open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three doses of an intramuscular, inactivated poliomyelitis vaccine (IPV) in 400 healthy infants. The primary objective was the non-inferiority of neutralizing antibody (nAb) responses in the concomitant- versus the staggered-use groups. Antibody responses were measured at baseline and 1-month post-dose 3 (PD3). Parents/legal guardians recorded adverse events for 30 or 15 d after study vaccinations in the concomitant-use or staggered-use groups, respectively. At PD3, >98% of participants seroconverted to all three poliovirus types, and the primary objective was met as lower bounds of the two-sided 95% CI for between-group difference in nAb seroconversion percentages ranged from - 4.3% to - 1.6%, for all poliovirus types, p < .001. At PD3, geometric mean titers (GMTs) of nAb responses to poliovirus types 1, 2, and 3 in the concomitant-use group and the staggered-use group were comparable; 100% of participants had nAb titers ≥1:8 and ≥1:64 for all poliovirus types. Anti-rotavirus serotype-specific IgA GMTs and participants with ≥3-fold rise in postvaccination titers from baseline were comparable between groups. Administration of RV5 and IPV was well tolerated with comparable safety profiles in both groups. The immunogenicity of IPV in the concomitant-use group was non-inferior to the staggered-use group and RV5 was immunogenic in both groups. No safety concerns were identified. These data support the concomitant use of RV5 and IPV in healthy Chinese infants.
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  • 文章类型: Randomized Controlled Trial
    背景:在大型队列的上市后研究中,没有关于第4次加强剂量的sIPV免疫在18-24个月大的儿童中的免疫原性和安全性的数据,这些研究提供了可靠的结果。
    方法:在Ⅳ期随机分组中,双盲临床试验,1200名2个月大的参与者在2、3和4个月大的时候用三个连续剂量的sIPV免疫以完成初次免疫。在1200名参与者中,1129接受第4剂sIPV作为加强免疫。在1100名参与者中评估了免疫原性。
    结果:抗脊髓灰质炎病毒1型、2型和3型中和抗体的血清阳性率为99.9%,98.0%,98.2%,分别,初次疫苗接种后一年的GMTs为557.0、146.1、362.0。在18至24个月大的加强疫苗接种后,3种类型的血清阳性率均达到100.0%,GMT分别为8343.6、5039.6、5492.0。特别是抗脊髓灰质炎病毒2型抗体,初次免疫后的GMT为230.4,在初次免疫接种后一年维持到146.1,并在加强疫苗接种后增加到高达5039.6。加强免疫后各批次组之间的GMT比率在0.67和1.50之间,满足免疫学等效性标准。不良反应发生率为23.0%,与Ⅲ期试验相当,但发生率较低。此外,本研究未报道SUSAR。
    结论:结论:随着抗脊髓灰质炎病毒抗体在sIPV初次疫苗接种后一年逐渐减弱,特别是2型抗体下降到非常低的水平,提示加强免疫对18-24个月大的儿童的重要性。加强注射可以大大提高抗体水平,并通过补充当前现实世界中的抗脊髓灰质炎病毒2型免疫缺口来保护儿童免受WPV和VDPV感染的潜在风险。诊所试验登记。NCT04224519。
    BACKGROUND: There has been no data on the immunogenicity and safety of the 4th booster dose of the sIPV immunization in 18-24 months old children in post-marketing studies of large cohort providing with robust results.
    METHODS: In a phase Ⅳ randomized, double-blinded clinical trial, 1200 participants aged 2 months were immunized with three consecutive doses of sIPV at 2, 3, and 4 months old to complete primary immunization. Out of the 1200 participants, 1129 received the 4th dose of sIPV as booster immunization. Immunogenicity was evaluated in 1100 participants.
    RESULTS: Seropositive rates of the anti-poliovirus type 1, 2, and 3 neutralizing antibodies were 99.9 %, 98.0 %, 98.2 %, respectively, with GMTs of 557.0, 146.1, 362.0 one year after primary vaccination. After booster vaccination between 18 and 24 months old, the seropositive rates for 3 types all reached 100.0 %, with GMTs of 8343.6, 5039.6, 5492.0, respectively. Particularly for the anti-poliovirus type 2 antibody, the GMT was 230.4 after primary immunization, maintained to 146.1 one year after primary immunization, and increased to as high as 5039.6 after booster vaccination. The GMT ratios between each batch groups after booster immunization were between 0.67 and 1.50, meeting the immunological equivalence criteria. The incidence rate of adverse reaction was 23.0 %, which was comparable to those in the phase Ⅲ trial but had a lower incidence. Furthermore, no SUSAR was reported in this study.
    CONCLUSIONS: In conclusion, as the anti-poliovirus antibodies gradually waned one year post sIPV primary vaccination, especially the type 2 antibody waned to a very low level, suggesting the importance of the booster immunization for children at the age of 18-24 months old. The booster shot can greatly enhance the antibody level and protect children from the potential risk of infection with WPV and VDPV by supplementing the anti-poliovirus type 2 immunity gap in the current real world. Clinic Trial Registration. NCT04224519.
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  • 文章类型: Randomized Controlled Trial
    背景:本研究旨在评估不同类型脊髓灰质炎病毒疫苗的免疫原性和安全性。
    方法:随机,失明,单中心,采用并行控制设计,选择360名≥2个月的婴儿作为研究对象.他们被随机分配到bOPV组(口服Sabin疫苗)和sIPV组(Sabin株灭活脊髓灰质炎疫苗),每组180名婴儿。记录接种疫苗的受试者的不良反应事件。使用细胞培养进行微量中和试验,以确定抗脊髓灰质炎病毒I型中和抗体的几何平均滴度(GMT),II,和III在不同的组中,并计算血清转化率。
    结果:两组在加强免疫后表现出100%的血清阳性率。三种类型的中和抗体的滴度主要分布在1:128至1:512的范围内。I型抗体的倍数增加在两组之间有显著差异(P<0.05)。此外,脊髓灰质炎病毒II型和III型抗体的倍数增加在两组之间略有差异(P>0.05)。sIPV组的增加率为4倍,明显优于bOPV组(P<0.05)。在比较完成脊髓性肌萎缩症全程疫苗接种的个体免疫后GMT的I型抗体水平时,bOPV组明显低于sIPV组(P<0.05)。对于II型和III型抗体,bOPV组个体免疫后GMT水平明显优于sIPV组(P<0.05)。bOPV组和sIPV组的不良反应发生率差异不大(P>0.05)。
    结论:这些结果表明,口服疫苗和灭活疫苗在≥2个月婴儿中具有良好的安全性和免疫原性。sIPV组血清中产生的中和抗体水平较高,在II型和III型免疫后GMT水平中尤其明显。
    BACKGROUND: This study aimed to evaluate the immunogenicity and safety of different types of poliovirus vaccines.
    METHODS: A randomized, blinded, single-center, parallel-controlled design was employed, and 360 infants aged ≥ 2 months were selected as study subjects. They were randomly assigned to bOPV group (oral Sabin vaccine) and sIPV group (Sabin strain inactivated polio vaccine), with 180 infants in each group. Adverse reaction events in the vaccinated subjects were recorded. The micro-neutralization test using cell culture was conducted to determine the geometric mean titer (GMT) of neutralizing antibodies against poliovirus types I, II, and III in different groups, and the seroconversion rates were calculated.
    RESULTS: Both groups exhibited a 100% seropositivity rate after booster immunization. The titers of neutralizing antibodies for the three types were predominantly distributed within the range of 1:128 to 1:512. The fold increase of type I antibodies differed markedly between the two groups (P < 0.05). Moreover, the fold increase of type II and type III antibodies for poliovirus differed slightly between the two groups (P > 0.05). The fourfold increase rate in sIPV group was drastically superior to that in bOPV group (P < 0.05). When comparing the post-immunization GMT levels of type I antibodies in individuals who completed the full course of spinal muscular atrophy vaccination, bOPV group showed greatly inferior levels to sIPV group (P < 0.05). For type II and type III antibodies, individuals in bOPV group demonstrated drastically superior post-immunization GMT levels to those in sIPV group (P < 0.05). The incidence of adverse reactions between the bOPV and sIPV groups differed slightly (P > 0.05).
    CONCLUSIONS: These findings indicated that both the oral vaccine and inactivated vaccine had good safety and immunogenicity in infants aged ≥ 2 months. The sIPV group generated higher levels of neutralizing antibodies in serum, particularly evident in the post-immunization GMT levels for types II and III.
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  • 文章类型: Journal Article
    2019年,我们对广东省脊髓灰质炎病毒血清阳性率进行了横断面研究,中国。我们评估了不同人口群体血清中脊髓灰质炎NA和GMT的阳性率,并将当前发现与2014年的切换前数据进行了比较.采用多级随机抽样方法,每个城市随机选择四个县/区,在每一个之内,选择了一家综合医院和两家乡镇医院。邀请了健康的人来进行体检或接种疫苗。收集并测试了总共1318个个体样品。在非新生儿中,年龄依赖性阳性率PV1NA为77.8%~100%,PV3NA为70.3%~98.9%(p<.01).两种类型的最低GMT值(17.03和8.46)发生在20至<30岁年龄组,而PV1和PV3的峰值GMT在1至<2(340.14)和0至<1岁(168.90)年龄组中观察到,分别。粤东地区PV1(P=.002)和PV3(P=.007)的GMT低于其他三个地区。男性参与者的GMT高于女性(分别为P=.016和.033)。在新生人口中,与PV3相比,男性和女性均显示出更高的PV1NA阳性率和GMT(p<0.05)。切换后的PV3NA阳性率高于切换前的阳性率(p=0.016)。PV1和PV3的GMT在转换后显著较高(p<.001)。NAs和GMT的阳性率保持较高水平,在抵抗脊髓灰质炎感染中起着重要作用。转换后的免疫程序的效果比以前更明显。
    In 2019, we conducted a cross-sectional study for polio virus seroprevalence in Guangdong province, China. We assessed the positivity rates of poliomyelitis NA and GMT in serum across various demographic groups, and the current findings were compared with pre-switch data from 2014. Using multistage random sampling method, four counties/districts were randomly selected per city, and within each, one general hospital and two township hospitals were chosen. Healthy individuals coming for medical checkups or vaccination were invited. A total of 1318 individual samples were collected and tested. In non-newborn population, age-dependent positivity rates ranged from 77.8% to 100% for PV1 NA and 70.3% to 98.9% for PV3 NA (p < .01). The lowest GMT values for both types (17.03 and 8.46) occurred in the 20 to <30 years age group, while peak GMTs for PV1 and PV3 were observed in 1 to <2 (340.14) and 0 to <1-year (168.90) age groups, respectively. GMTs for PV1 (P = .002) and PV3 (P = .007) in Eastern Guangdong were lower than those in the other three regions. Male participants showed higher GMTs than females (P = .016 and .033, respectively). In newborn population, both males and females showed higher PV1 NA positivity rates and GMTs compared to PV3 (p < .05). Post-switch PV3 NA positivity rates were higher than pre-switch rates (p = .016). GMTs of both PV1 and PV3 were significantly higher post-switch (p < .001). The positivity rates of NAs and GMTs remain high level, which play an important role in resisting poliomyelitis infection. Effect of the converted immunization program was more pronounced than that before.
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  • 文章类型: Randomized Controlled Trial
    目标:在COVID-19大流行期间,疫苗覆盖率下降了,联合疫苗的实施和共同给药策略成为缓解这一困境的潜在解决方案。我们的目标是深入研究基于sabin株的灭活脊髓灰质炎病毒疫苗(sIPV)的同时给药,白喉-破伤风-无细胞百日咳疫苗(DTaP)和麻疹-腮腺炎-风疹疫苗(MMR),旨在弥合中国婴儿疫苗联合管理的证据差距,并确保安全和有效的疫苗接种策略,最终导致免疫覆盖率的增加。
    方法:这项研究是一项随访试验,涉及儿童同时使用sIPV和DTaP疫苗的免疫原性和安全性:多中心,随机化,非自卑,对照试验。在第0天和第30天收集血液样品,并检测血清抗体水平以测量对每种抗原的抗体应答。监测并比较各组间的局部和全身不良事件(AE)。这项研究首次填补了中国关于安全有效的sIPV联合疫苗接种的知识空白,DTaP,MMR疫苗。
    结果:脊髓灰质炎病毒1、2和3型中和抗体的GMT为1060.22(95%CI:865.73-1298.39),第1组第30天的1537.06(95%CI:1324.27-1784.05)和1539.10(95%CI:1296.37-1827.29);同时接种组的DTaP和MMR抗体的GMT不劣于单独的DTaP和单独的MMR组。两组之间的局部和全身不良反应的报告率相似,并且在整个临床研究期间均未报告严重不良事件(SAE)。
    结论:sIPV的共同管理,DTaP和MMR是安全的,对免疫原性没有影响,这将有助于降低管理成本并提高疫苗覆盖率。
    OBJECTIVE: During the COVID-19 pandemic, there was a decline in vaccine coverage, and the implementation of combined vaccines and co-administration strategies emerged as potential solutions to alleviate this predicament. Our objective is to delve into the concurrent administration of the sabin-strain-based inactivated poliovirus vaccine (sIPV), the diphtheria-tetanus-acellular pertussis vaccine (DTaP), and measles-mumps-rubella vaccine (MMR), with the intention of bridging the evidentiary gap pertaining to vaccine co-administration in Chinese infants, and to ensure a safe and effective vaccination strategy, ultimately leading to an augmentation in immunization coverage.
    METHODS: This study was a follow-up trial of the \"Immunogenicity and safety of concomitant administration of the sIPV with the DTaP vaccine in children: a multicenter, randomized, non-inferiority, controlled trial.\" Blood samples were collected on day 0 and day 30, and serum antibody levels were detected to measure antibody responses to each of the antigens. Local and systemic adverse events were monitored and compared among groups. This study is the first to fill the knowledge gap in China regarding the safe and effective combined vaccination of sIPV, DTaP, and MMR vaccines.
    RESULTS: The geometric mean titer of the poliovirus types I, II, and III neutralizing antibodies were 1060.22 (95% CI: 865.73-1298.39), 1537.06 (95% CI: 1324.27-1784.05), and 1539.10 (95% CI: 1296.37-1827.29) in group I on day 30; geometric mean titer of antibodies against DTaP and MMR in the simultaneous vaccination group was non-inferior to those in the DTaP alone and MMR alone group. Reporting rates of local and systemic adverse reactions were similar between groups and no serious adverse events were reported throughout the clinical study period.
    CONCLUSIONS: Co-administration of the sIPV, DTaP, and MMR was safe and did not impact immunogenicity, which would help to mitigate administrative costs and enhance vaccine coverage rates.
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  • 文章类型: Case Reports
    2013年江西省确诊1例免疫缺陷疫苗源性脊髓灰质炎病毒(iVDPV),中国。在这项研究中,我们从该病例中纯化了14株3型原始病毒分离株,并对这些iVDPV的分子进化进行了298天的表征.在大多数原始病毒分离物中发现了遗传变异,变异体之间复杂的遗传和进化关系。基于P1区域构建的系统发育树表明,这些iVDPV被分为谱系A和B。显性谱系B代表了病毒进化的主要趋势。BEAST程序估计的第三个密码子位置(3CP)的核苷酸取代率为1.76×10-2取代/位点/年(95%HPD:1.23-2.39×10-2)。最初的OPV剂量可以追溯到2013年3月,接近上次OPV疫苗接种的时间,这表明OPV感染可能起源于最后一剂疫苗。重组分析表明,这些iVDPV是具有两种重组模式的疫苗间重组体,S3/S2/S1和S3/S2/S3/S2/S1。全基因组序列分析显示,关键核苷酸位点(C472U,C2034U,与Sabin3的减毒表型相关的U2493C)已被替换。温度敏感性试验表明,所有受试菌株均对温度敏感,除了变体Day11-5。有趣的是,我们观察到变体Day11-5温度抗性特性可能与VP2-162位点处的Lys至Met取代相关。血清学检测和全基因组序列分析显示,抗原位点的突变并没有显着改变中和能力。
    In 2013, a case of immunodeficiency vaccine-derived poliovirus (iVDPV) was identified in Jiangxi Province, China. In this study, we purified 14 type 3 original viral isolates from this case and characterized the molecular evolution of these iVDPVs for 298 days. Genetic variants were found in most of the original viral isolates, with complex genetic and evolutionary relationships among the variants. A phylogenetic tree constructed based on the P1 region showed that these iVDPVs were classified into lineage A and B. The dominant lineage B represents a major trend in virus evolution. The nucleotide substitution rate at the third codon position (3CP) estimated by the BEAST program was 1.76 × 10-2 substitutions/site/year (95% HPD: 1.23-2.39 × 10-2). The initial OPV dose was given dating back to March 2013, which was close to the time of the last OPV vaccination, suggesting that OPV infection may have originated with the last dose of vaccine. Recombinant analysis showed that these iVDPVs were inter-vaccine recombinants with two recombination patterns, S3/S2/S1 and S3/S2/S3/S2/S1. Whole genome sequence analysis revealed that key nucleotide sites (C472U, C2034U, U2493C) associated with the attenuated phenotype of Sabin 3 have been replaced. Temperature sensitivity test showed that all tested strains were temperature-sensitive, except for the variant Day11-5. Interestingly, we observed that the variant Day11-5 temperature resistance properties may be associated with the Lys to Met substitution at the VP2-162 site. Serological test and whole genome sequence analysis showed that the seropositivity rate remained high, and mutations in the antigenic sites did not significantly alter neutralization ability.
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  • 文章类型: Journal Article
    萨宾灭活和二价口服脊髓灰质炎病毒疫苗(sIPV,bOPV)自2016年以来在中国普遍使用。我们进行了一个开放标签,随机化,对照4期试验,以评估sIPV或bOPV序贯免疫后的免疫持久性,4岁儿童加强剂量脊髓灰质炎病毒疫苗的免疫原性和安全性。
    先前临床试验的参与者在2、3和4个月时使用sIPV(I)或bOPV(B)进行了三种不同的序贯时间表(I-B-B组,I-I-B,I-I-I)在2017年被跟进。在I-B-B组给予sIPV后,将儿童进一步分为五个亚组,I-I-B组和I-I-I组随机给予sIPV或bOPV(I-B-B-I组中的128名儿童,I-I-B-B组60人,64在I-I-B-I组中,68在I-I-I-B组中,67在I-I-I-I组中)。通过测量脊髓灰质炎病毒类型特异性抗体来评估免疫持久性和免疫原性。对所有接受加强剂量的儿童进行安全性分析.
    在2020年12月5日至2021年6月30日之间,我们分别在免疫持久性分析中招募了381名参与者,和352名参与者参与了加强免疫的免疫原性分析。初次免疫四年后,抗脊髓灰质炎病毒1型和3型抗体的血清阳性率均>90%,而2型脊髓灰质炎病毒为46.83%,75.41%,I-B-B组为90.23%(χ2=60.948,P<0.001),I-I-B,而我-我-我,分别。加强剂量后,I-B-B-I组中所有三种血清型的血清阳性率均为100%,I-I-B-I和I-I-I-I;在I-I-B-B和I-I-I-B组中,1型和3型的血清阳性率均为100%,2型为92.59%和98.46%。对脊髓灰质炎病毒1和3的几何平均滴度(GMTs)在五组中都很高(>1860.73),在bOPV增强组中,针对2型的GMT显着降低:I-I-B-B组(50.60)和I-I-I-B组(247.84)。I-I-B-I组和I-I-I-I组三种血清型的血清阳性率或GMTs均无显着差异(P>0.05)。研究期间未发生严重不良事件。
    我们的研究结果表明,在目前的常规脊髓灰质炎病毒免疫接种计划中至少需要两次sIPV剂量,与中国目前的sIPV-sIPV-bOPV-bOPV时间表相比,包含3或4剂sIPV的时间表提供了更好的针对2型脊髓灰质炎病毒的保护。
    浙江省医药卫生科技(2021KY118)。该试验在ClinicalTrials.gov(NCT04576910)注册。
    UNASSIGNED: Sabin inactivated and bivalent oral poliovirus vaccine (sIPV, bOPV) were commonly used in China since 2016. We conducted an open-label, randomised, controlled phase 4 trial to assess immune persistence following sequential immunisation with sIPV or bOPV, and immunogenicity and safety of a booster dose of poliovirus vaccine in children aged 4 years.
    UNASSIGNED: Participants from a previous clinical trial with three different sequential schedules with sIPV (I) or bOPV (B) at ages 2, 3, and 4 months (Groups I-B-B, I-I-B, I-I-I) in 2017 were followed-up. The children were further divided into five subgroups after sIPV was given for Group I-B-B, and sIPV or bOPV randomly given for Group I-I-B and Group I-I-I (128 children in Groups I-B-B-I, 60 in Group I-I-B-B, 64 in Group I-I-B-I, 68 in Group I-I-I-B, 67 in Group I-I-I-I). Immune persistence and immunogenicity were assessed by measuring poliovirus type-specific antibodies, and safety were analysed in all children who received the booster dose.
    UNASSIGNED: Between Dec 5, 2020 and Jun 30, 2021, we respectively enrolled 381 participants in the immune persistence analysis, and 352 participants in per protocol (PP) analysis of the immunogenicity of the booster immunisation. Seropositivity rates of antibodies against poliovirus types 1 and 3 were all >90% four years after primary immunisation, while for poliovirus type 2 were 46.83%, 75.41%, and 90.23% (χ2 = 60.948, P < 0.001) for Groups I-B-B, I-I-B, and I-I-I, respectively. After the booster dose, seropositivity rates were 100% for all three serotypes in Group I-B-B-I, I-I-B-I and I-I-I-I; In Group I-I-B-B and I-I-I-B, the seropositivity rates for types 1 and 3 were all 100%, for type 2 were 92.59% and 98.46%. The geometric mean titres (GMTs) against poliovirus 1 and 3 were all high in five groups (>1860.73), and the GMTs against type 2 were significantly lower in groups booster with bOPV: Group I-I-B-B (50.60) and Group I-I-I-B (247.84). There was no significant difference in seropositivity rates or GMTs for all three serotypes (P > 0.05) between Group I-I-B-I and I-I-I-I. No serious adverse events occurred during the study.
    UNASSIGNED: Our findings suggest that at least two sIPV doses are needed in the current routine poliovirus immunisation schedule, and schedules containing 3 or 4 doses of sIPV provide better protection against poliovirus type 2 than the current sIPV-sIPV-bOPV-bOPV schedule in China.
    UNASSIGNED: Medical and Health Science and Technology of Zhejiang Province (2021KY118). This trial was registered with ClinicalTrials.gov (NCT04576910).
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