Delving into the Latest Updates on Enterovirus type 71 vaccine, inactivated(Chinese Academy of Medical Sciences) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Enterovirus Type 71 Vaccine, Inactivated(Human Diploid cell), 肠道病毒71型灭活疫苗（人二倍体细胞）, 宜维福

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Hand, Foot and Mouth Disease

Inactive Indication-

Originator Organization

Chinese Academy of Medical Sciences

Active Organization

Zhong Guo Yi Xue Ke Xue Yuan Yi Xue Sheng Wu Xue Yan Jiu Suo

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (01 Dec 2015),

Hand, Foot and Mouth Disease

RegulationSpecial Review Project (CN)

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This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged 18-49 years), adolescent (aged 6-17 years) and infant subjects (aged 2-71 months). Primary objectives of the clinical trial include assessing the safety and tolerability of IRV given at two and three dose levels and comparing the safety and tolerability of IRV after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status. Secondary objective of the clinical trial is immunogenicity evaluation after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status.

Start Date03 Dec 2020

Sponsor / Collaborator

Chinese Academy of Medical Sciences

NCT06209398 / Active, not recruitingPhase 4IIT

Study on the Immunogenicity and Safety of Inactivated Enterovirus Type 71 Vaccine Combined Administration With Recombinant Hepatitis B and Group A Meningococcal Vaccine

The main purpose of this study is to evaluate the immunogenicity and safety of inactivated enterovirus type 71 vaccine combined with recombinant hepatitis B vaccine or Group a meningococcal polysaccharide vaccine.

Start Date24 May 2018

Sponsor / Collaborator

Jiangsu Province Centers for Disease Control and Prevention

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100 Clinical Results associated with Enterovirus type 71 vaccine, inactivated(Chinese Academy of Medical Sciences)

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100 Translational Medicine associated with Enterovirus type 71 vaccine, inactivated(Chinese Academy of Medical Sciences)

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100 Patents (Medical) associated with Enterovirus type 71 vaccine, inactivated(Chinese Academy of Medical Sciences)

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3

Literatures (Medical) associated with Enterovirus type 71 vaccine, inactivated(Chinese Academy of Medical Sciences)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Immunogenicity and safety of an inactivated COVID-19 vaccine (CoronaVac®) co-administered with an inactivated enterovirus type 71 vaccine (Inlive®): A phase 4, randomized, controlled trial

Article

Author: Shu, Qun ; Wang, Lianhao ; Huang, Zhuhang ; Ying, Zhifang ; Meng, Xing ; Zhang, Hengming ; Sun, Zhuoqun ; Gao, Fan ; Chen, Shaomin ; Zhang, Jikai ; Shu, Yajun

TRIAL REGISTRATION NUMBERNCT04993365 (ClinicalTrials.gov).

01 Jan 2007·VaccineQ3 · MEDICINE

High immunogenic enterovirus 71 strain and its production using serum-free microcarrier Vero cell culture

Q3 · MEDICINE

Article

Author: Chia-Chyi Liu ; Michael Butler ; Wei-Cheng Lian ; Suh-Chin Wu

Developing an effective vaccine against enterovirus 71 (EV71) infection provides the best means to control the disease. We have previously reported that large-scale preparation of a low immunogenic EV71 strain can be achieved using serum free microcarrier Vero cell culture in a 2-l bioreactor [Wu SC, Liu CC, Lian WC. Optimization of microcarrier cell culture process for the inactivated enterovirus type 71 vaccine development. Vaccine 2004;22:3858-64]. This present work further investigated the virus growth and the immunogenicity of two high immunogenic strains (EV71-075 and EV71-117) prepared in serum-free microcarrier cell cultures. Our results showed that serum free culture increased cell death rate after infection, reduced the virus specific productivity, but resulted in elicitation of higher neutralizing titers in immunized mice as compared to that parallel obtained in serum-containing cultures. Therefore, serum-free microcarrier culture is a valuable process for developing inactivated EV71 vaccines.

28 Sep 2004·VaccineQ3 · MEDICINE

Optimization of microcarrier cell culture process for the inactivated enterovirus type 71 vaccine development

Q3 · MEDICINE

Article

Author: Wei-Cheng Lian ; Chia-Chyi Liu ; Suh-Chin Wu

Enterovirus 71 (EV71) is an enterovirus that could lead to severe neurological disorders and fatalities. The inactivated vaccine is an appropriate EV71 vaccine format for meeting current needs. Large-scale preparation of the inactivated EV71vaccine depends on a scalable cell culture system for industrial mass production. In this paper, Vero cells were found to produce higher titers of EV71 than did MRC-5 and WI-38 cells. High-density microcarrier Vero cell cultures were established using 5g/L Cytodex 1 microcarriers and found to promote the release of EV71s from infected Vero cells. For the large-scale production of the inactivated vaccine antigen, the extracellular virus titers produced in the 2L bioreactor were found to be 10 times lower than the spinner flask culture but improved by 30-folds using glucose/glutamine feedings during infection. A serum-free Vero cell microcarrier culture was also established in the bioreactor, yielding a high-titer of 5.8 x 10(7) TCID50/mL for EV71 production. The immunogenicity of the inactivated virions produced in serum-free culture elicited a slightly higher level of neutralizing antibody response in immunized mice. These results constitute valuable information on the development of a large-scale microcarrier cell culture process for producing inactivated EV71 vaccine.

100 Deals associated with Enterovirus type 71 vaccine, inactivated(Chinese Academy of Medical Sciences)

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