Abstract：
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.
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.
摘要：
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。
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。
