Safety, Immunogenicity and Lot-to-Lot Consistency of Sabin-Strain Inactivated Poliovirus Vaccine in 2-Month-Old Infants: A Double-Blind, Randomized Phase III Trial

被引:4
|
作者
Zheng, Yan [1 ]
Ying, Zhifang [2 ]
Zou, Yanxiang [1 ]
Zhu, Taotao [3 ]
Qian, Dinggu [4 ]
Han, Weixiao [3 ]
Jiang, Ya [5 ]
Jiang, Zhiwei [6 ]
Li, Xingyan [7 ]
Wang, Jianfeng [3 ]
Lei, Jin [8 ]
Xu, Li [9 ]
Jiang, Deyu [10 ]
Li, Changgui [2 ]
Liu, Xiaoqiang [1 ]
机构
[1] Vaccine Clin Res Ctr, Yunnan Prov Ctr Dis Control & Prevent, Kunming, Peoples R China
[2] Natl Inst Food & Drug Control, Biol Prod Inst, Resp Virus Vaccine Dept, Beijing 100050, Peoples R China
[3] Sinovac Biotech Co Ltd, Dept Clin Res, Beijing 100089, Peoples R China
[4] Qiubei Cty Ctr Dis Control & Prevent, Vaccine Clin Res Proj Off, Wenshan Zhuang & Miao Autonomous Prefecture, Beijing 663299, Peoples R China
[5] Mile Cty Ctr Dis Control & Prevent, Vaccine Clin Res Project Off, Honghe Hani & Yi Autonomous Prefecture, Beijing 652399, Peoples R China
[6] Beijing Key Tech Stat Consulting Co Ltd, Dept Stat, Beijing 100025, Peoples R China
[7] Yanshan Cty Ctr Dis Control & Prevent, Div Acute Infect Dis Control & Prevent, Wenshan Zhuang & Miao Autonomous Prefecture, Beijing 663299, Peoples R China
[8] Gejiu Cty Ctr Dis Control & Prevent, Immunizat Program Div, Honghe Hani & Yi Autonomous Prefecture, Beijing 661099, Peoples R China
[9] Sinovac Biotech Co Ltd, Qual Assurance Dept, Beijing 100089, Peoples R China
[10] Sinovac Life Sci Co Ltd, R&D Dept, Beijing 102629, Peoples R China
关键词
Sabin strain; inactivated poliovirus vaccine; lot-to-lot consistency; safety; immunogenicity; IPV;
D O I
10.3390/vaccines10020254
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background: 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. Method: 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. Results: 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. Conclusions: 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.
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页数:10
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