Immunogenicity and safety of inactivated enterovirus A71 vaccines in children aged 6-35 months in China: a non-inferiority, randomised controlled trial

Summary: Background: China's three inactivated enterovirus A71 (EV-A71) vaccines are the first and currently world's only EV-A71 vaccines approved by a national regulatory authority and used to prevent EV-A71 associated diseases. The three vaccines vary by vaccine strain, manufacturing ce...

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Autores principales:	Yan Li, Fan Gao, Yamin Wang, Jing Li, Yuxi Zhang, Huakun Lv, Shenyu Wang, Haitao Yang, Xiaoqiang Liu, Keli Li, Huaqing Wang, Zundong Yin, Zhenglun Liang, Zhijie An, Qunying Mao, Zijian Feng
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Immunogenicity safety inactivated enterovirus-A71 vaccines children aged 6-35 months Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/5eaa001bdc604baf8958d3a9766eae82
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spelling	oai:doaj.org-article:5eaa001bdc604baf8958d3a9766eae822021-12-02T05:04:06ZImmunogenicity and safety of inactivated enterovirus A71 vaccines in children aged 6-35 months in China: a non-inferiority, randomised controlled trial2666-606510.1016/j.lanwpc.2021.100284https://doaj.org/article/5eaa001bdc604baf8958d3a9766eae822021-11-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2666606521001930https://doaj.org/toc/2666-6065Summary: Background: China's three inactivated enterovirus A71 (EV-A71) vaccines are the first and currently world's only EV-A71 vaccines approved by a national regulatory authority and used to prevent EV-A71 associated diseases. The three vaccines vary by vaccine strain, manufacturing cell substrate, and antigen dose, but no head-to-head comparisons of these vaccines have been done. We compared immunogenicity of the vaccines in children 6-35 months old. Methods: We recruited healthy children aged 6-35 months who lived in a study site county into a multicentre, open-label, non-inferiority, three-group, randomised controlled trial that was conducted in five counties in China. Enrolled children were randomly assigned (1:1:1) to receive two doses of one of the three EV-A71 vaccines. The primary outcome was the proportion of children with EV-A71 neutralizing antibody seroconversion 4 weeks after the second dose; a secondary outcome was adverse events in the 4 weeks after each dose. Analyses of immunogenicity included all children who completed the study (per-protocol analysis). Safety analysis included all children completed safety follow-up after at least one. We used a 10% margin to establish non-inferiority. This trial was registered on a World Health Organization platform: Chinese Clinical Trial Registry (ChiCTR1900026663). Findings: 1631 children were assessed for eligibility between Nov 4 and Nov 20, 2019. Of 1500 (92%) enrolled children, 500 were assigned to vaccine group A, B, or C; 483 in group A,484 in group B, and 487 in group C completed the study. Before dose one, the seropositive rates in groups A, B, and C were 9.7%, 7.2%, and 7.0%. Four weeks after the second dose, seroconversion rates of groups A, B, and C were 98.8%, 99.4% and 99.8% - mutually non-inferior in all two-group comparisons. There were no serious adverse events in any group and no evidence of a difference among the three groups in the incidence of local adverse event or systemic adverse event. Fever was the most common adverse event. All children with reported adverse events recovered. Interpretation: Non-inferior and high seroconversion rates and equivalent safety of three EV-A71 vaccines supports use any of these vaccines to prevent EV-A71-associated diseases. These results may be useful for regulators, vaccine policy makers, and immunization programmes in China and in countries where EV-A71 is endemic.Yan LiFan GaoYamin WangJing LiYuxi ZhangHuakun LvShenyu WangHaitao YangXiaoqiang LiuKeli LiHuaqing WangZundong YinZhenglun LiangZhijie AnQunying MaoZijian FengElsevierarticleImmunogenicitysafetyinactivated enterovirus-A71 vaccineschildren aged 6-35 monthsPublic aspects of medicineRA1-1270ENThe Lancet Regional Health. Western Pacific, Vol 16, Iss , Pp 100284- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Immunogenicity safety inactivated enterovirus-A71 vaccines children aged 6-35 months Public aspects of medicine RA1-1270
spellingShingle	Immunogenicity safety inactivated enterovirus-A71 vaccines children aged 6-35 months Public aspects of medicine RA1-1270 Yan Li Fan Gao Yamin Wang Jing Li Yuxi Zhang Huakun Lv Shenyu Wang Haitao Yang Xiaoqiang Liu Keli Li Huaqing Wang Zundong Yin Zhenglun Liang Zhijie An Qunying Mao Zijian Feng Immunogenicity and safety of inactivated enterovirus A71 vaccines in children aged 6-35 months in China: a non-inferiority, randomised controlled trial
description	Summary: Background: China's three inactivated enterovirus A71 (EV-A71) vaccines are the first and currently world's only EV-A71 vaccines approved by a national regulatory authority and used to prevent EV-A71 associated diseases. The three vaccines vary by vaccine strain, manufacturing cell substrate, and antigen dose, but no head-to-head comparisons of these vaccines have been done. We compared immunogenicity of the vaccines in children 6-35 months old. Methods: We recruited healthy children aged 6-35 months who lived in a study site county into a multicentre, open-label, non-inferiority, three-group, randomised controlled trial that was conducted in five counties in China. Enrolled children were randomly assigned (1:1:1) to receive two doses of one of the three EV-A71 vaccines. The primary outcome was the proportion of children with EV-A71 neutralizing antibody seroconversion 4 weeks after the second dose; a secondary outcome was adverse events in the 4 weeks after each dose. Analyses of immunogenicity included all children who completed the study (per-protocol analysis). Safety analysis included all children completed safety follow-up after at least one. We used a 10% margin to establish non-inferiority. This trial was registered on a World Health Organization platform: Chinese Clinical Trial Registry (ChiCTR1900026663). Findings: 1631 children were assessed for eligibility between Nov 4 and Nov 20, 2019. Of 1500 (92%) enrolled children, 500 were assigned to vaccine group A, B, or C; 483 in group A,484 in group B, and 487 in group C completed the study. Before dose one, the seropositive rates in groups A, B, and C were 9.7%, 7.2%, and 7.0%. Four weeks after the second dose, seroconversion rates of groups A, B, and C were 98.8%, 99.4% and 99.8% - mutually non-inferior in all two-group comparisons. There were no serious adverse events in any group and no evidence of a difference among the three groups in the incidence of local adverse event or systemic adverse event. Fever was the most common adverse event. All children with reported adverse events recovered. Interpretation: Non-inferior and high seroconversion rates and equivalent safety of three EV-A71 vaccines supports use any of these vaccines to prevent EV-A71-associated diseases. These results may be useful for regulators, vaccine policy makers, and immunization programmes in China and in countries where EV-A71 is endemic.
format	article
author	Yan Li Fan Gao Yamin Wang Jing Li Yuxi Zhang Huakun Lv Shenyu Wang Haitao Yang Xiaoqiang Liu Keli Li Huaqing Wang Zundong Yin Zhenglun Liang Zhijie An Qunying Mao Zijian Feng
author_facet	Yan Li Fan Gao Yamin Wang Jing Li Yuxi Zhang Huakun Lv Shenyu Wang Haitao Yang Xiaoqiang Liu Keli Li Huaqing Wang Zundong Yin Zhenglun Liang Zhijie An Qunying Mao Zijian Feng
author_sort	Yan Li
title	Immunogenicity and safety of inactivated enterovirus A71 vaccines in children aged 6-35 months in China: a non-inferiority, randomised controlled trial
title_short	Immunogenicity and safety of inactivated enterovirus A71 vaccines in children aged 6-35 months in China: a non-inferiority, randomised controlled trial
title_full	Immunogenicity and safety of inactivated enterovirus A71 vaccines in children aged 6-35 months in China: a non-inferiority, randomised controlled trial
title_fullStr	Immunogenicity and safety of inactivated enterovirus A71 vaccines in children aged 6-35 months in China: a non-inferiority, randomised controlled trial
title_full_unstemmed	Immunogenicity and safety of inactivated enterovirus A71 vaccines in children aged 6-35 months in China: a non-inferiority, randomised controlled trial
title_sort	immunogenicity and safety of inactivated enterovirus a71 vaccines in children aged 6-35 months in china: a non-inferiority, randomised controlled trial
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/5eaa001bdc604baf8958d3a9766eae82
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Immunogenicity and safety of inactivated enterovirus A71 vaccines in children aged 6-35 months in China: a non-inferiority, randomised controlled trial

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