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).

Conclusion

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.

中文翻译：

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各类脊髓性肌萎缩症疫苗免疫原性及安全性观察分析

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

采用随机、盲法、单中心、平行对照设计，选取360名≥2月龄婴儿作为研究对象。随机分为bOPV组（口服沙宾疫苗）和sIPV组（沙宾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。采用细胞培养物进行微量中和试验，测定不同组别脊髓灰质炎病毒I、II、III型中和抗体的几何平均滴度（GMT），并计算血清转化率。

结果

加强免疫后，两组均表现出 100% 的血清阳性率。三种类型的中和抗体效价主要分布在1:128至1:512范围内。两组I型抗体增加倍数差异显着（P  <0.05）。此外，两组间脊髓灰质炎病毒II型和III型抗体的增加倍数略有差异（P  >0.05）。 sIPV 组的 4 倍增加率明显优于 bOPV 组（P  < 0.05）。比较完成脊髓性肌萎缩症疫苗全程接种者的免疫后GMT水平，bOPV组明显低于sIPV组（P  < 0.05）。对于 II 型和 III 型抗体，bOPV 组个体的免疫后 GMT 水平明显优于 sIPV 组个体（P  < 0.05）。 bOPV 组和 sIPV 组不良反应发生率略有差异（P  > 0.05）。

结论

这些结果表明，口服疫苗和灭活疫苗对≥2月龄婴儿均具有良好的安全性和免疫原性。 sIPV 组在血清中产生更高水平的中和抗体，尤其是 II 型和 III 型免疫后 GMT 水平。