Immunization Program Department, Daqing Center for Disease Control and Prevention, Daqing, 163000, Heilongjiang, China.
Pathology Department, Daqing People's Hospital, Daqing, 163000, Heilongjiang, China.
Inflammopharmacology. 2024 Apr;32(2):1025-1038. doi: 10.1007/s10787-023-01395-7. Epub 2024 Feb 3.
This study aimed to evaluate the immunogenicity and safety of different types of poliovirus vaccines.
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.
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).
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.
本研究旨在评估不同类型脊灰病毒疫苗的免疫原性和安全性。
采用随机、双盲、单中心、平行对照设计，选取≥2 月龄的 360 名婴儿作为研究对象，随机分为 bOPV 组（口服萨宾疫苗）和 sIPV 组（Sabin 株脊灰灭活疫苗），每组 180 名。记录接种对象的不良反应事件。采用细胞培养微量中和试验测定不同组别脊灰病毒 I、II、III 型中和抗体的几何平均滴度（GMT），并计算血清转化率。
两组加强免疫后均达到 100%的血清阳性率。三种类型的中和抗体滴度主要分布在 1:128 至 1:512 之间。两组间 I 型抗体的倍数增加差异有统计学意义（P<0.05）。此外，两组间 II 型和 III 型脊灰病毒抗体的倍数增加差异较小（P>0.05）。sIPV 组的四倍增长率明显优于 bOPV 组（P<0.05）。比较全程脊髓灰质炎疫苗接种者 I 型抗体的免疫后 GMT 水平，bOPV 组明显低于 sIPV 组（P<0.05）。对于 II 型和 III 型抗体，bOPV 组的免疫后 GMT 水平明显优于 sIPV 组（P<0.05）。bOPV 组和 sIPV 组不良反应发生率差异较小（P>0.05）。
本研究表明，≥2 月龄婴儿口服疫苗和灭活疫苗均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，尤其是 II 型和 III 型的免疫后 GMT 水平更为明显。
