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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

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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8879689/
https://www.ncbi.nlm.nih.gov/pubmed/35214712
http://dx.doi.org/10.3390/vaccines10020254
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author 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
author_facet 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
author_sort Zheng, Yan
collection PubMed
description 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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spelling pubmed-88796892022-02-26 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 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 Vaccines (Basel) Article 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. MDPI 2022-02-08 /pmc/articles/PMC8879689/ /pubmed/35214712 http://dx.doi.org/10.3390/vaccines10020254 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
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
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8879689/
https://www.ncbi.nlm.nih.gov/pubmed/35214712
http://dx.doi.org/10.3390/vaccines10020254
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