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-

Action

stimulants

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-

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (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

[+1]

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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54

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

31 Dec 2025·Human Vaccines & Immunotherapeutics

Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in China

Article

Author: Cui, Shiheng ; Sun, Li ; Zhu, Yiqing ; Wang, Yihan ; Guo, Yu ; Wang, Jinghui ; Li, Jing ; Wang, Yafei

To comprehensively assess the safety and difference of two types of EV71 vaccines: EV71-Vero, produced using Vero cells and EV71-H2, using human diploid cells. Our research included children of the recommended age who voluntarily received the EV71 vaccine in Hebei Province from 2019 to 2023. Detailed data on adverse events following immunization (AEFI) were collected, analyzed and compared for EV71-Vero and EV71-H2 vaccines. With 477 AEFI reported, the reported rate was 14.21 per 100,000 doses. Most cases occurred in infants under one year of age (45.91%). No significant differences in the AEFI reported rate were found between two types of EV71 vaccines across various demographic. However, a higher number of AEFI was reported in children under 1-year old following EV71-Vero compared to EV71-H2 with a reversal in 4-5 years- group (χ² = 13.90, p = .01). The prognosis of cured took higher proportion for EV71-Vero than for EV71-H2 while inversely with improved outcome. The EV71 vaccine is advisable recommend to the appropriate age children to prevent EV7l infection. Both the EV71-Vero and EV71-H2 vaccines have good safety profiles. The reported AEFI, primarily high fever and allergic reactions, showed no significant differences in reported rates or case characteristics between the two types.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Safety of an inactivated enterovirus 71 vaccine administered concurrently with other vaccines among infants aged 6–11 months: An observational study using active surveillance

Article

Author: Shao, Huiyong ; Ma, Xiaoying ; Wu, Linlin ; Huang, Zhuoying ; Sun, Xiaodong ; Liu, Jiechen ; Zhang, Yu

Vaccine co-administration can efficiently increase vaccination uptake and timely immunization. This study aimed to evaluate the safety of the enterovirus 71 (EV71) vaccine administered alone or concurrently with other vaccines in infants 6-11 months. A total of 3,769 EV71 vaccine doses were administered to children in the active surveillance area, of which 1,909 were administered concurrently with other vaccines and 1,860 doses were administered alone. Active surveillance was conducted to observe adverse events (AEs) within 0-7 and ≥8 days after vaccination and to determine the incidence of reported AEs. The overall AE incidence was 2.12% (95% CI: 1.66%-2.58%), with 1.56% (95% CI:1.00%-2.12%) for the EV71 vaccine alone and 2.67% (95% CI: 1.95%-3.40%) for simultaneous administration of the EV71 vaccine and other vaccines (__-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__x2 = 5.612, p = .018). The solicited local AE incidence was 1.00% (95% CI: 0.55%-1.44%) in the EV71 vaccine co-administration group and 0.59% (95% CI: 0.24%-0.94%) in the EV71 vaccine alone group (__-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__x2 = 1.946, p = .018). The solicited systemic AE incidence was 1.68% (95% CI: 1.10%-2.25%) and 0.86% (95% CI: 0.44%-1.28%) in the EV71 vaccine co-administered and EV71 vaccine alone groups, respectively (__-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__x2 = 4.990, p = .025). No serious vaccine-related AEs were reported. Fever was the most common AE; no difference was observed in the incidence rate of fever between the two groups (__-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__x2 = 3.467, p = .063). Overall, AE incidence following EV71 vaccination alone or concurrently with other vaccines was acceptable; concurrent vaccination did not increase AE risk or severity.

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

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

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