Inactivated poliovirus vaccines

  • 文章类型: Clinical Trial
    近年来,全球根除小儿麻痹症倡议已逐步实施了小儿麻痹症免疫计划的全球转变。很少有研究涵盖脊髓灰质炎免疫计划对其他疫苗效力的影响。这项研究调查了脊髓灰质炎免疫计划是否影响甲型肝炎(HepA)和乙型肝炎(HepB)疫苗接种效果。在第一次接种脊髓灰质炎疫苗之前,从968名婴儿收集血清样本,完成脊髓灰质炎初级免疫接种后28天,在24个月大的时候。将婴儿分为六个脊髓灰质炎免疫计划组:1sIPV+2bOPV,2sIPV+1bOPV,2sIPV+1tOPV,1cIPV+2bOPV,2cIPV+1bOPV,和2cIPV+1tOPV(sIPV:萨宾脊髓灰质炎病毒灭活疫苗;cIPV:索尔克脊髓灰质炎病毒灭活疫苗;b,二价;t,三价;OPV,口服脊髓灰质炎疫苗)。在三个时间点的任何一个时间点,脊髓灰质炎免疫计划组的抗HepA病毒(抗HAV)抗体滴度均无显著差异(首次给药前[p=0.412],初次免疫后28天[p=0.676],24个月大[p=0.556])。在第一次给药之前(p=0.178)和24个月大(p=0.987),六个脊髓灰质炎免疫计划组之间的HepB表面抗体(HBsAb)滴度没有显着差异)。初次免疫接种后28天,Bonferroni校正后,两组之间的HBsAb滴度没有显着差异。HepA和HepB免疫后,抗HAV和HBsAb阳性在所有组中达到>98%,反映有效免疫。我们的数据表明,不同的脊髓灰质炎免疫计划不会影响HepA和HepB疫苗的效力;无论脊髓灰质炎免疫计划如何,HepA和HepB疫苗均保持较高的有效性。该试验在ClinicalTrials.gov:NCT03614702上注册。
    In recent years, the Global Polio Eradication Initiative has gradually implemented a global shift in polio immunization programs. Few studies cover polio immunization program impacts on the efficacy of other vaccines. This study investigated whether polio immunization programs affected hepatitis A (HepA) and hepatitis B (HepB) vaccination efficacy. Serum samples were collected from 968 infants before the first dose of polio vaccine, 28 days after completing primary polio immunization, and at 24 months old. Infants were classified into six polio immunization program groups: 1sIPV+2bOPV, 2sIPV+1bOPV, 2sIPV+1tOPV, 1cIPV+2bOPV, 2cIPV+1bOPV, and 2cIPV+1tOPV (sIPV: Sabin inactivated poliovirus vaccine; cIPV: Salk inactivated poliovirus vaccine; b, bivalent; t, trivalent; OPV, oral polio vaccine). No significant differences existed in antibody titers against HepA virus (anti-HAV) among the polio immunization program groups at any of the three time points (pre-first dose [p = 0.412], 28 days after primary immunization [p = 0.676], 24 months old [p = 0.556]). Before the first dose (p = 0.178) and at age 24 months (p = 0.987), no significant differences existed in HepB surface antibody (HBsAb) titers between the six polio immunization program groups). Twenty-eight days after primary immunization, no significant difference existed in HBsAb titers between groups after Bonferroni correction. Following HepA and HepB immunization, anti-HAV and HBsAb positivity reached > 98% in all groups, reflecting effective immunization. Our data suggest that different polio immunization programs did not affect HepA and HepB vaccine efficacy; HepA and HepB vaccines maintained high effectiveness irrespective of polio immunization program. This trial was registered on Clinical Trials.gov: NCT03614702.
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  • 文章类型: Journal Article
    一剂灭活脊髓灰质炎病毒疫苗(IPV)于2016年被引入中国扩大免疫计划(EPI)。由Sabin菌株制成的IPV(sIPV)在中国是新许可的,其安全性一直受到关注。本研究旨在评估sIPV的安全性,并与野生菌株(wIPV)制成的常规IPV进行比较。我们从2016-2019年中国国家免疫后不良事件信息系统(CNAEFIS)收集了江苏所有与IPV相关的AEFI报告。我们从江苏省电子免疫登记系统(JSEIRS)获得了IPV的给药剂量。比较了sIPV和wIPV的每100,000剂量疫苗的AEFI报告率。2016-2019年江苏CNAEFIS共收集sIPV和wIPVAEFI病例699例。sIPV和wIPV的总体AEFI报告率为每100,000剂量53.02,每100,000剂量41.25,分别(P<.001)。对于sIPV和wIPV,AEFI主要归类为常见不良反应.sIPV的常见不良反应报告率高于wIPV(P<.001)。最常报告的症状/体征是发烧,持续的哭泣,注射部位红斑/肿胀,皮疹,和注射部位硬化。只有1.14%的sIPV相关和2.31%的wIPV相关的AEFI病例被诊断为严重。严重AEFI的报告率没有差异(P=0.272)。sIPV具有良好的安全性,尽管其常见不良反应的报告率略高于wIPV。
    One dose of inactivated poliovirus vaccine (IPV) was introduced into the Chinese Expanded Program on Immunization (EPI) in 2016. IPV made from Sabin strains (sIPV) was newly licensed in China and its safety has been concerned. This study aimed to evaluate the safety of sIPV and provide a comparison with conventional IPV made from wild strains (wIPV). We collected all IPV-related AEFI reports in Jiangsu from the Chinese National Adverse Events Following Immunization Information System (CNAEFIS) for 2016-2019. We obtained the administered doses of IPV from the Jiangsu provincial Electronic Immunization Registries System (JSEIRS). The AEFI reporting rates per 100,000 doses of vaccine administered were compared for sIPV and wIPV. A total of 699 sIPV and 908 wIPV AEFI cases were collected by CNAEFIS in Jiangsu during 2016-2019. The overall AEFI reporting rates were 53.02 per 100,000 doses and 41.25 per 100,000 doses for sIPV and wIPV, respectively (P < .001). For both sIPV and wIPV, the AEFIs were mainly classified as common adverse reactions. The reporting rate of common adverse reactions was higher for sIPV than for wIPV (P < .001). The most frequently reported symptoms/signs were fever, persistent crying, injection site erythema/swelling, rash, and injection site induration. Only 1.14% of sIPV-associated and 2.31% of wIPV-associated AEFI cases were diagnosed as serious. No difference in reporting rate was observed for serious AEFIs (P = .272). sIPV has a favorable safety profile, although it exhibits a slightly higher reporting rate of common adverse reactions than wIPV.
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  • 文章类型: Comparative Study
    The emergence of vaccine-associated paralytic poliomyelitis has become an ongoing burden of poliomyelitis. During this special period from OPV to IPV-only immunization schedule, we did a meta-analysis to compare the immunogenicity of sequential IPV and OPV versus IPV alone in healthy infants.
    This systematic review and meta-analysis was registered at international prospective register of systematic reviews (PROSPERO), and the number was CRD42017054889. We performed it as described.
    Finally, 6 articles were qualified for our review. The results showed that seroconversion rates against all 3 serotype polioviruses were non-inferior and Geometric mean antibody titers (GMTs) were superior in sequential schedules compared with IPV-only schedule. Thus, the sequential vaccination schedules could induce a stronger immunogenicity.
    To decrease vaccine-associated and vaccine-derived poliomyelitis, it is a reasonable option to select sequential schedules during this special transition from OPV to IPV-only immunization schedule, which coincides with the current WHO recommendations.
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