Zheng Yan, Ying Zhifang, Zou Yanxiang, Zhu Taotao, Qian Dinggu, Han Weixiao, Jiang Ya, Jiang Zhiwei, Li Xingyan, Wang Jianfeng, Lei Jin, Xu Li, Jiang Deyu, Li Changgui, Liu Xiaoqiang
Vaccine Clinical Research Center, Yunnan Provincial Center for Disease Control and Prevention, Kunming 650034, China.
Respiratory Virus Vaccine Department, Biological Product Institute, National Institutes for Food and Drug Control, Beijing 100050, China.
Vaccines (Basel). 2022 Feb 8;10(2):254. doi: 10.3390/vaccines10020254.
The Sabin-strain-based inactivated poliovirus vaccine (sIPV) plays an important role in poliomyelitis eradication in developing countries. As part of the phase III clinical development program, this study aimed to evaluate the safety, immunogenicity and lot-to-lot consistency of the sIPV in 2-month-old infants.
We conducted a phase III, randomized, double-blind, positive-controlled trial in which 1300 healthy infants were randomly assigned to four groups in a 1:1:1:1 ratio to receive one of the three lots of the sIPV or the control IPV at 2, 3 and 4 months of age. Serum samples were collected before the first dose and 30 days after the third dose of vaccination to assess the immunogenicity. Solicited local and systemic reactions were recorded within 7 days and unsolicited adverse events within 30 days after each vaccination.
Of the 1300 randomized infants, 1190 infants completed the study and were included in the per-protocol population. The seroconversion rates in the three lots of the sIPV were 95.67%, 97.03% and 95.59%, respectively, for type 1; 94.33%, 93.73% and 92.88%, respectively, for type 2; and 98.67%, 99.67% and 99.32%, respectively, for type 3. The ratios of GMTs for poliovirus types 1, 2 and 3 of each pair of lots were all between 0.67 and 1.50, therefore meeting the predefined immunological equivalence criteria. For the seroconversion rate of poliovirus types 1, 2 and 3, the pooled sIPV group was non-inferior to the IPV group. The incidence of solicited and unsolicited adverse reactions (ARs) was similar in the pooled sIPV lots and the IPV group, and most of them were mild to moderate in severity. Non-vaccine-related serious adverse events (SAEs) were reported.
Three consecutive lots of sIPV demonstrated robust and consistent immunogenicity. The safety and tolerability of the sIPV was acceptable and similar to that of the IPV.
基于萨宾株的灭活脊髓灰质炎病毒疫苗（sIPV）在发展中国家的脊髓灰质炎根除工作中发挥着重要作用。作为III期临床开发项目的一部分，本研究旨在评估sIPV在2月龄婴儿中的安全性、免疫原性和批次间一致性。
我们开展了一项III期随机双盲阳性对照试验，将1300名健康婴儿按1:1:1:1的比例随机分为四组，在2、3和4月龄时分别接种三批sIPV中的一批或对照IPV。在首剂接种前及第三剂接种后30天采集血清样本，以评估免疫原性。在每次接种后7天内记录主动报告的局部和全身反应，30天内记录被动报告的不良事件。
1300名随机分组的婴儿中，1190名婴儿完成了研究并纳入符合方案人群。三批sIPV中，1型脊髓灰质炎病毒的血清阳转率分别为95.67%、97.03%和95.59%；2型分别为94.33%、93.73%和92.88%；3型分别为98.67%、99.67%和99.32%。每两批脊髓灰质炎病毒1、2和3型的几何平均滴度（GMT）比值均在0.67至1.50之间，因此符合预先定义的免疫学等效标准。对于脊髓灰质炎病毒1、2和3型的血清阳转率，合并的sIPV组不劣于IPV组。合并的sIPV批次和IPV组中主动报告和被动报告的不良反应（AR）发生率相似，且大多数为轻至中度。报告了与疫苗无关的严重不良事件（SAE）。
连续三批sIPV表现出强大且一致的免疫原性。sIPV的安全性和耐受性是可接受的，且与IPV相似。
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