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EV71 vaccine, an invaluable gift for children.

ABSTRACT: Enterovirus 71 (EV71) is a major pathogen for severe hand, foot and mouth disease (HFMD). Development of vaccines against EV71 would be the most effective approach to prevent the EV71 outbreak. Research and development (R&D) of EV71 vaccine was carried out in several Asian countries. Currently three companies in mainland China have completed Phase III clinical trials of inactivated EV71 whole-virus vaccines, whereas the other two companies have completed Phase I clinical trials separately in Taiwan and in Singapore. Results from those clinical trials have indicated high safety and immunogenicity of EV71 vaccine. Protective efficacies were over 90% on EV71-associated HFMD and over 80% on other EV71-associated diseases. In this paper, we summarize the results from three EV71 vaccine Phase III clinical trials and discuss the challenges of incorporating EV71 vaccine into Expanded Program on Immunization (EPI) in countries with EV71 epidemics.

SUBMITTER: Liang Z

PROVIDER: S-EPMC4237031 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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EV71 vaccine, an invaluable gift for children.

Liang Zhenglun Z Wang Junzhi J

Clinical & translational immunology 20141031 10

Enterovirus 71 (EV71) is a major pathogen for severe hand, foot and mouth disease (HFMD). Development of vaccines against EV71 would be the most effective approach to prevent the EV71 outbreak. Research and development (R&D) of EV71 vaccine was carried out in several Asian countries. Currently three companies in mainland China have completed Phase III clinical trials of inactivated EV71 whole-virus vaccines, whereas the other two companies have completed Phase I clinical trials separately in Tai ...[more]

PMID: 25505956

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Project description:Enterovirus 71 (EV71) is now recognized as an emerging neurotropic virus in Asia and with Coxsackie virus (CV) it is the other major causative agent of hand-foot-mouth diseases (HFMD). Effective medications and/or prophylactic vaccines against HFMD are urgently needed. From a scientific (the feasibility of bioprocess, immunological responses and potency in animal challenge model) and business development (cost of goods) points of view, we in this review address and discuss the pros and cons of different EV71 vaccine candidates that have been produced and evaluated in animal models. Epitope-based synthetic peptide vaccine candidates containing residues 211-225 of VP1 formulated with Freund's adjuvant (CFA/IFA) elicited low EV71 virus neutralizing antibody responses, but were protective in the suckling mouse challenge model. Among recombinant EV71 subunits (rVP1, rVP2 and rVP3) expressed in E. coli, purified and formulated with CFA/IFA, only VP1 elicited mouse antibody responses with measurable EV71-specific virus neutralization titers. Immunization of mice with either a DNA plasmid containing VP1 gene or VP1 expressed in Salmonella typhimurium also generated neutralizing antibody responses and protected animals against a live EV71 challenge. Recombinant EV71 virus-like particles (rVLP) produced from baculovirus formulated either with CFA/IFA or alum elicited good virus neutralization titers in both mice and non-human primates, and were found to be protective in the suckling mouse EV71 challenge model. Synthetic peptides or recombinant EV71 subunit vaccines (rVP1 and rVLP) formulated in alum were found to be poorly immunogenic in rabbits. Only formalin-inactivated (FI) EV71 virions formulated in alum elicited cross-neutralizing antibodies against different EV71 genotypes in mice, rabbits and non-human primates but induced weak neutralizing responses against CAV16. From a regulatory, economic and market acceptability standpoint, FI-EV71 virion vaccines are the most promising candidates and are currently being evaluated in human clinical trials. We further describe and analyze some new bioprocesses technologies that have great potential applications in EV71 vaccine development. This review also demonstrates the opportunities and challenges that the Asian vaccine industry faces today.

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EV71 vaccine, an invaluable gift for children.

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EV71 vaccine, an invaluable gift for children.

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