Delving into the Latest Updates on Enterovirus 71 vaccine(Wuhan Institute of Biological Products) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Enterovirus 71 Vaccine(Vero Cell), Inactivated, Enterovirus 71 Vaccine（Vero Cell），Inactivated, 肠道病毒71型灭活疫苗(Vero细胞) (武汉生物制品研究所)

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Hand, Foot and Mouth Disease

Inactive Indication-

Originator Organization

Wuhan Institute of Biological Products Co., Ltd.

Active Organization

Wuhan Institute of Biological Products Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (13 Dec 2016),

Hand, Foot and Mouth Disease

Regulation-

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The primary objective of this study is to evaluate the immunogenicity and safety of 2 doses of EV71 vaccine in children aged 36-71 months. The secondary objectives are to evaluate the long-term safety of 2 doses of EV71 vaccine in children aged 36-71 months and to evaluate the immune persistence of EV71 vaccine in children aged 36-71 months.

Start Date03 Jun 2020

Sponsor / Collaborator

Sinopharm Zhongsheng Biotechnology Research Institute Co., Ltd

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NCT04091880 / CompletedPhase 4

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine (Split Virion),Inactivated

Subjects will be recruited and divided into 3 groups:
Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine;
Control Group A (378 subjects): EV71 vaccine only;
Control Group B (378 subjects): influenza vaccine only;
All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.

Start Date26 Sep 2019

Sponsor / Collaborator

China National Biotec Group Co., Ltd.

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CTR20191913 / RecruitingPhase 4

评价EV71疫苗与Ⅲ价流感裂解疫苗联合接种安全性及免疫原性的多中心、随机、对照临床研究

[Translation] A multicenter, randomized, controlled clinical study to evaluate the safety and immunogenicity of combined EV71 vaccine and III-valent influenza split vaccine

主要目的为评价EV71灭活疫苗与3价流感裂解疫苗同时接种对抗体阳转率的影响；次要目的为评价EV71灭活疫苗与3价流感裂解疫苗同时接种对抗体水平的影响；评价EV71灭活疫苗与3价流感裂解疫苗同时接种的安全性。

[Translation]

The primary objective is to evaluate the effect of simultaneous administration of EV71 inactivated vaccine and trivalent influenza split vaccine on antibody seroconversion rate; the secondary objective is to evaluate the effect of simultaneous administration of EV71 inactivated vaccine and trivalent influenza split vaccine on antibody level; and to evaluate the safety of simultaneous administration of EV71 inactivated vaccine and trivalent influenza split vaccine.

Start Date19 Sep 2019

Sponsor / Collaborator

Sinopharm Zhongsheng Biotechnology Research Institute Co., Ltd

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100 Clinical Results associated with Enterovirus 71 vaccine(Wuhan Institute of Biological Products)

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100 Translational Medicine associated with Enterovirus 71 vaccine(Wuhan Institute of Biological Products)

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100 Patents (Medical) associated with Enterovirus 71 vaccine(Wuhan Institute of Biological Products)

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68

Literatures (Medical) associated with Enterovirus 71 vaccine(Wuhan Institute of Biological Products)

01 Oct 2024·Journal of Infection

The effectiveness and impact of the enterovirus 71 vaccine on the onset of hand, foot, and mouth disease in children aged ≤5 years: A 7-year study

Letter

Author: Zhan, Siyi ; Fan, Chenlu ; Sun, Xiu ; Fu, Chuanxi ; Yang, Yingying

06 Oct 2023·Vaccine

Effect of enterovirus 71 vaccine on epidemiological characteristics of hand, foot and mouth disease: An 8-year retrospective intermittent time series analysis.

Article

Author: Wang, Dao-Bin ; Song, Chun-Lan ; Li, Peng ; Li, Chang-Qing ; Zhang, Xue ; Jia, Wan-Yu ; Li, Zheng

18 Apr 2023·Vaccines

Safety and Immunogenicity of Enterovirus 71 Vaccine (Vero Cell) Administered Simultaneously with Trivalent Split-Virion Influenza Vaccine in Infants Aged 6-7 Months: A Phase 4, Randomized, Controlled Trial.

Article

Author: Ruan, Jiewei ; Yang, Xiaoming ; Zhang, Min ; Wu, Lixia ; Long, Lin ; Chen, Yaping ; Liu, Haibo ; Yu, Xiaoqing ; Luo, Linyun ; Xiao, Yanhui ; Chen, Haiping ; Chen, Wei ; Xu, Weichai ; Guo, Xue ; Hou, Renwu ; Ma, Yong ; Zhang, Yanyang

Objective: To assess the immunogenicity and safety of the enterovirus 71 vaccine (Vero cell) (EV71 vaccine) and trivalent split-virion influenza vaccine (IIV3). Methods: Healthy infants aged 6-7 months were recruited from Zhejiang Province, Henan Province, and Guizhou Province and randomly assigned to the simultaneous vaccination group, EV71 group, and IIV3 group at a ratio of 1:1:1. Then, 3 mL blood samples were collected before vaccination and 28 days after the second dose of vaccine. Cytopathic effect inhibition assay was used to detect EV71 neutralization antibody, and cytopathic effect inhibition assay was used to detect influenza virus antibody. Results: A total of 378 infants were enrolled and received the first dose of vaccine and were included in the safety analysis, and 350 infants were involved in the immunogenicity analysis. The adverse events rates were 31.75%, 28.57%, and 34.13% in the simultaneous vaccination group, EV71 group, and IIV3 group (p > 0.05), respectively. No vaccine-related serious adverse events were reported. After two doses of EV71 vaccine, the seroconversion rates of EV71 neutralizing antibody were 98.26% and 97.37% in the simultaneous vaccination group and the EV71 group, respectively. After two doses of IIV3, the simultaneous vaccination group and the IIV3 group, respectively, had seroconversion rates of 80.00% and 86.78% for H1N1 antibody, 99.13% and 98.35% for H3N2 antibody, and 76.52% and 80.99% for B antibody. There was no statistically significant difference in the seroconversion rates of influenza virus antibodies between groups (p > 0.05). Conclusions: The coadministration of EV71 vaccine and IIV3 has good safety and immunogenicity in infants aged 6-7 months.

100 Deals associated with Enterovirus 71 vaccine(Wuhan Institute of Biological Products)

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