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Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial

Safe and effective vaccines against SARS-CoV-2 for children are urgently needed. Here we aimed to assess the safety and immunogenicity of an inactivated COVID-19 vaccine candidate, WIBP-CorV, in participants aged 3-17 years. A randomized, double-blind, placebo-controlled, phase 1/2 clinical trial wa...

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Autores principales: Xia, Shengli, Duan, Kai, Zhang, Yuntao, Zeng, Xiaoqing, Zhao, Dongyang, Zhang, Huajun, Xie, Zhiqiang, Li, Xinguo, Peng, Cheng, Zhang, Wei, Yang, Yunkai, Chen, Wei, Gao, Xiaoxiao, You, Wangyang, Wang, Xuewei, Wang, Zejun, Shi, Zhengli, Wang, Yanxia, Yang, Xuqin, Li, Qingliang, Huang, Lili, Wang, Qian, Lu, Jia, Yang, Yongli, Guo, Jing, Zhou, Wei, Wan, Xin, Wu, Cong, Wang, Wenhui, Huang, Shihe, Du, Jianhui, Nian, Xuanxuan, Deng, Tao, Yuan, Zhiming, Shen, Shuo, Guo, Wanshen, Liu, Jia, Yang, Xiaoming
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9265248/
https://www.ncbi.nlm.nih.gov/pubmed/35812412
http://dx.doi.org/10.3389/fimmu.2022.898151
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author Xia, Shengli
Duan, Kai
Zhang, Yuntao
Zeng, Xiaoqing
Zhao, Dongyang
Zhang, Huajun
Xie, Zhiqiang
Li, Xinguo
Peng, Cheng
Zhang, Wei
Yang, Yunkai
Chen, Wei
Gao, Xiaoxiao
You, Wangyang
Wang, Xuewei
Wang, Zejun
Shi, Zhengli
Wang, Yanxia
Yang, Xuqin
Li, Qingliang
Huang, Lili
Wang, Qian
Lu, Jia
Yang, Yongli
Guo, Jing
Zhou, Wei
Wan, Xin
Wu, Cong
Wang, Wenhui
Huang, Shihe
Du, Jianhui
Nian, Xuanxuan
Deng, Tao
Yuan, Zhiming
Shen, Shuo
Guo, Wanshen
Liu, Jia
Yang, Xiaoming
author_facet Xia, Shengli
Duan, Kai
Zhang, Yuntao
Zeng, Xiaoqing
Zhao, Dongyang
Zhang, Huajun
Xie, Zhiqiang
Li, Xinguo
Peng, Cheng
Zhang, Wei
Yang, Yunkai
Chen, Wei
Gao, Xiaoxiao
You, Wangyang
Wang, Xuewei
Wang, Zejun
Shi, Zhengli
Wang, Yanxia
Yang, Xuqin
Li, Qingliang
Huang, Lili
Wang, Qian
Lu, Jia
Yang, Yongli
Guo, Jing
Zhou, Wei
Wan, Xin
Wu, Cong
Wang, Wenhui
Huang, Shihe
Du, Jianhui
Nian, Xuanxuan
Deng, Tao
Yuan, Zhiming
Shen, Shuo
Guo, Wanshen
Liu, Jia
Yang, Xiaoming
author_sort Xia, Shengli
collection PubMed
description Safe and effective vaccines against SARS-CoV-2 for children are urgently needed. Here we aimed to assess the safety and immunogenicity of an inactivated COVID-19 vaccine candidate, WIBP-CorV, in participants aged 3-17 years. A randomized, double-blind, placebo-controlled, phase 1/2 clinical trial was conducted in Henan Province, China, in healthy children aged 3-17 years. 240 participants in phase 1 trial and 576 participants in phase 2 trial were randomly assigned to vaccine or control with an age de-escalation in three cohorts (3-5, 6-12 and 13-17 years) and dose-escalation in three groups (2.5, 5.0 and 10.0μg/dose), and received 3 intramuscular injections at day 0, 28, and 56. WIBP-CorV showed a promising safety profile with approximately 17% adverse reactions within 30 days after injection and no grade 3 or worse adverse events. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting. The geometric mean titers of neutralizing antibody ranged from 102.2 to 1065.5 in vaccinated participants at 28 days after the third vaccination, and maintained at a range of 14.3 to 218.2 at day 180 after the third vaccination. WIBP-CorV elicited significantly higher titers of neutralizing antibody in the cohort aged 3-5 years than the other two cohorts. There were no detectable antibody responses in all alum-only groups. Taken together, our data demonstrate that WIBP-CorV is safe and well tolerated at all tested doses in participants aged 3-17 years, and elicited robust humoral responses against SARS-CoV-2 lasted for at least 6 months after the third vaccination. This study is ongoing and is registered with www.chictr.org.cn, ChiCTR2000031809.
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spelling pubmed-92652482022-07-09 Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial Xia, Shengli Duan, Kai Zhang, Yuntao Zeng, Xiaoqing Zhao, Dongyang Zhang, Huajun Xie, Zhiqiang Li, Xinguo Peng, Cheng Zhang, Wei Yang, Yunkai Chen, Wei Gao, Xiaoxiao You, Wangyang Wang, Xuewei Wang, Zejun Shi, Zhengli Wang, Yanxia Yang, Xuqin Li, Qingliang Huang, Lili Wang, Qian Lu, Jia Yang, Yongli Guo, Jing Zhou, Wei Wan, Xin Wu, Cong Wang, Wenhui Huang, Shihe Du, Jianhui Nian, Xuanxuan Deng, Tao Yuan, Zhiming Shen, Shuo Guo, Wanshen Liu, Jia Yang, Xiaoming Front Immunol Immunology Safe and effective vaccines against SARS-CoV-2 for children are urgently needed. Here we aimed to assess the safety and immunogenicity of an inactivated COVID-19 vaccine candidate, WIBP-CorV, in participants aged 3-17 years. A randomized, double-blind, placebo-controlled, phase 1/2 clinical trial was conducted in Henan Province, China, in healthy children aged 3-17 years. 240 participants in phase 1 trial and 576 participants in phase 2 trial were randomly assigned to vaccine or control with an age de-escalation in three cohorts (3-5, 6-12 and 13-17 years) and dose-escalation in three groups (2.5, 5.0 and 10.0μg/dose), and received 3 intramuscular injections at day 0, 28, and 56. WIBP-CorV showed a promising safety profile with approximately 17% adverse reactions within 30 days after injection and no grade 3 or worse adverse events. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting. The geometric mean titers of neutralizing antibody ranged from 102.2 to 1065.5 in vaccinated participants at 28 days after the third vaccination, and maintained at a range of 14.3 to 218.2 at day 180 after the third vaccination. WIBP-CorV elicited significantly higher titers of neutralizing antibody in the cohort aged 3-5 years than the other two cohorts. There were no detectable antibody responses in all alum-only groups. Taken together, our data demonstrate that WIBP-CorV is safe and well tolerated at all tested doses in participants aged 3-17 years, and elicited robust humoral responses against SARS-CoV-2 lasted for at least 6 months after the third vaccination. This study is ongoing and is registered with www.chictr.org.cn, ChiCTR2000031809. Frontiers Media S.A. 2022-06-24 /pmc/articles/PMC9265248/ /pubmed/35812412 http://dx.doi.org/10.3389/fimmu.2022.898151 Text en Copyright © 2022 Xia, Duan, Zhang, Zeng, Zhao, Zhang, Xie, Li, Peng, Zhang, Yang, Chen, Gao, You, Wang, Wang, Shi, Wang, Yang, Li, Huang, Wang, Lu, Yang, Guo, Zhou, Wan, Wu, Wang, Huang, Du, Nian, Deng, Yuan, Shen, Guo, Liu and Yang https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Immunology
Xia, Shengli
Duan, Kai
Zhang, Yuntao
Zeng, Xiaoqing
Zhao, Dongyang
Zhang, Huajun
Xie, Zhiqiang
Li, Xinguo
Peng, Cheng
Zhang, Wei
Yang, Yunkai
Chen, Wei
Gao, Xiaoxiao
You, Wangyang
Wang, Xuewei
Wang, Zejun
Shi, Zhengli
Wang, Yanxia
Yang, Xuqin
Li, Qingliang
Huang, Lili
Wang, Qian
Lu, Jia
Yang, Yongli
Guo, Jing
Zhou, Wei
Wan, Xin
Wu, Cong
Wang, Wenhui
Huang, Shihe
Du, Jianhui
Nian, Xuanxuan
Deng, Tao
Yuan, Zhiming
Shen, Shuo
Guo, Wanshen
Liu, Jia
Yang, Xiaoming
Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial
title Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial
title_full Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial
title_fullStr Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial
title_full_unstemmed Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial
title_short Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial
title_sort safety and immunogenicity of an inactivated covid-19 vaccine, wibp-corv, in healthy children: interim analysis of a randomized, double-blind, controlled, phase 1/2 trial
topic Immunology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9265248/
https://www.ncbi.nlm.nih.gov/pubmed/35812412
http://dx.doi.org/10.3389/fimmu.2022.898151
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