EV71 vaccine, a new tool to control outbreaks of hand, foot and mouth disease (HFMD)

@article{Mao2016EV71VA,
  title={EV71 vaccine, a new tool to control outbreaks of hand, foot and mouth disease (HFMD)},
  author={Qunying Mao and Yi-ping Wang and Lian-lian Bian and Miao Xu and Zhenglun Liang},
  journal={Expert Review of Vaccines},
  year={2016},
  volume={15},
  pages={599 - 606}
}
ABSTRACT On December 3rd 2015, the China Food and Drug Administration (CFDA) approved the first inactivated Enterovirus 71 (EV71) whole virus vaccine for preventing severe hand, foot and mouth disease (HFMD). As one of the few preventive vaccines for children’s infectious diseases generated by the developing countries in recent years, EV71 vaccine is a blessing to children’s health in China and worldwide. However, there are still a few challenges facing the worldwide use of EV71 vaccine… 
Epidemiological and genetic characteristics of EV71 in hand, foot, and mouth disease in Guangxi, southern China, from 2010 to 2015
TLDR
Data showed that a two-year epidemic cycle, with a predominance of EV71 infections, contributed to HFMD outbreaks in Guangxi, and this virus is a major causative agent of severe and fatal HFMD.
Early evidence of inactivated enterovirus 71 vaccine impact against hand, foot, and mouth disease in a major center of ongoing transmission in China, 2011-2018: a longitudinal surveillance study.
  • J. Head, P. Collender, +12 authors J. Remais
  • Medicine
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
  • 2019
TLDR
The first real-world evidence that programmatic vaccination against EV71 is effective against childhood HFMD is provided and an approach to detect early vaccine impact or intended consequences from surveillance data is presented.
Enterovirus 71: a whole virion inactivated enterovirus 71 vaccine
TLDR
Among various vaccine candidates, the alum-adjuvant inactivated EV71 vaccines are most promising and international clinical trials are needed to further assess the efficacy and cross-immunogenicity.
Inactivated enterovirus A71 vaccines and moving forward
  • H. Shimizu
  • Medicine
    The Lancet regional health. Western Pacific
  • 2021
TLDR
A multicenter, open-label, non-inferiority, hree-group, randomized controlled clinical trial in children aged –35 months to compare the immunogenicity and safety of three nactivated EV-A71 vaccines currently available in China found no evidence of a difference mong the three groups in the incidence of local and systemic aderse events.
Impact of genetic changes, pathogenicity and antigenicity on Enterovirus- A71 vaccine development.
TLDR
The monovalent EV-A71 IV elicits humoral immunity but lacks long-term immunogenicity and chances of reversion is reduced by presence of multiple mutations which could reduce pathogenicity.
A comparative study of multiple clinical enterovirus 71 isolates and evaluation of cross protection of inactivated vaccine strain FY-23 K-B in vitro
TLDR
It is suggested that FY-23 K-B used as an antigen could elicit broad spectrum neutralizing antibodies with cross protective efficacy among C4 genotype strains.
Assessing the vaccine effectiveness for hand, foot, and mouth disease in Guangzhou, China: a time-series analysis
TLDR
Findings, based on real-world data, provide evidence of EV71 vaccine effectiveness for preventing EV71 and “other” viruses associated with HFMD.
Serotyping and Genetic Characterization of Hand, Foot, and Mouth Disease (HFMD)-Associated Enteroviruses of No-EV71 and Non-CVA16 Circulating in Fujian, China, 2011–2015
TLDR
VP1-based phylogenetic analysis for the 4 predominant serotypes indicated various clades or sub-clades, which suggests the complex transmissions of other enteroviruses in Fujian.
Preclinical evaluation of recombinant HFMD vaccine based on enterovirus 71 (EV71) virus-like particles (VLP): Immunogenicity, efficacy and toxicology.
TLDR
Nonclinical safety assessment of EV71 VLP vaccine showed no signs of systemic toxicity in animals, and the excellent immunogenicity, efficacy and toxicology data supported further evaluation of the VLP-based EV71 vaccine in humans.
The burden of hand, foot, and mouth disease among children under different vaccination scenarios in China: a dynamic modelling study
TLDR
The results point to the benefit of bivalent vaccine and using a pulse vaccination in specific months over routine vaccination, and other ways to control HFMD include isolation of patients in the early stage of dissemination, more frequent hand-washing and ventilation, and better treatment options for patients.
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References

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EV71 vaccine, an invaluable gift for children
TLDR
The results from three EV 71 vaccine Phase III clinical trials are summarized, the challenges of incorporating EV71 vaccine into Expanded Program on Immunization (EPI) in countries with EV71 epidemics are discussed and high safety and immunogenicity of EV71 vaccines are indicated.
Review of enterovirus 71 vaccines.
TLDR
The critical factors affecting EV71 vaccine product registration are discussed, including clinical epidemiology, antigenic shift issues in cross-protection and vaccine strain selection, standardized animal models for potency testing, and cost-effective manufacturing processes for potential incorporation of FI-EV71 vaccine into Expanded Programme on Immunization vaccines.
Prospect and challenges for the development of multivalent vaccines against hand, foot and mouth diseases.
TLDR
The critical bottlenecks in the development of multivalent HFMD vaccines are discussed, including the selection of vaccine strains, animal models to assess vaccine potency, the definition of end-points for efficacy trials, and the need for improved manufacturing processes to produce affordable vaccines.
Establishing China's national standards of antigen content and neutralizing antibody responses for evaluation of enterovirus 71 (EV71) vaccines.
TLDR
A antigen reference standard based on the C4 subtype of the EV71 vaccine strain was developed and national NTAb reference panels were found to effectively reduce assay discrepancy between different labs, which are highly valuable for the standardization and evaluation of EV71 vaccines.
Comparative Analysis of the Immunogenicity and Protective Effects of Inactivated EV71 Vaccines in Mice
TLDR
These studies establish a standard method for measuring the immunogenicity of EV71 vaccines in mice and establish a clear dose-response relationship, which is important for vaccine quality control and assessment, especially for predicting protective efficacy in humans when combined with future clinical trial results.
The Cross-Neutralizing Activity of Enterovirus 71 Subgenotype C4 Vaccines in Healthy Chinese Infants and Children
TLDR
The results demonstrated broad cross-neutralizing activity induced by two C4 EV71 vaccines in healthy Chinese infants and children, however, the degree of induced cross-protective immunity, and the potential escape evolution for EV71 still need to be monitored and researched in future.
An inactivated enterovirus 71 vaccine in healthy children.
TLDR
The inactivated EV71 vaccine elicited EV 71-specific immune responses and protection against EV71-associated hand, foot, and mouth disease, in healthy children 6 to 71 months of age in China.
Is a multivalent hand, foot, and mouth disease vaccine feasible?
TLDR
The current development of a bivalent inactivated EV-A71/CV-A16 vaccine is the next step toward that of multivalent HFMD vaccines, which should ultimately include other prevalent pathogenic coxsackieviruses A and CV-A10, and the prospect and challenges for the development of such multivalent vaccines are discussed.
Preclinical Evaluation of the Immunogenicity and Safety of an Inactivated Enterovirus 71 Candidate Vaccine
TLDR
The immunogenic and safety profile of inactivated, purified EV71 preparations formulated with aluminum hydroxide adjuvant in preclinical studies in mice and rabbits are reported, and Phase 1 clinical testing of the EV71 inactivated vaccine was initiated.
Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China.
TLDR
The EV71 vaccine provided protection against EV71-associated hand, foot, and mouth disease or herpangina in infants and young children.
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