Comparative analysis of the immunogenicity and protective effects of inactivated EV71 vaccines in mice.

Enterovirus 71 (EV71) is the major causative agent of hand, foot, and mouth disease (HFMD). Three inactivated EV71 whole-virus vaccines of different strains developed by different manufacturers in mainland China have recently entered clinical trials. Although several studies on these vaccines have b...

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Main Authors: Qunying Mao, Chenghong Dong, Xiuling Li, Qiang Gao, Zengbing Guo, Xin Yao, Yiping Wang, Fan Gao, Fengxiang Li, Miao Xu, Weidong Yin, Qihan Li, Xinliang Shen, Zhenglun Liang, Junzhi Wang
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2012-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC3460965?pdf=render
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author Qunying Mao
Chenghong Dong
Xiuling Li
Qiang Gao
Zengbing Guo
Xin Yao
Yiping Wang
Fan Gao
Fengxiang Li
Miao Xu
Weidong Yin
Qihan Li
Xinliang Shen
Zhenglun Liang
Junzhi Wang
author_facet Qunying Mao
Chenghong Dong
Xiuling Li
Qiang Gao
Zengbing Guo
Xin Yao
Yiping Wang
Fan Gao
Fengxiang Li
Miao Xu
Weidong Yin
Qihan Li
Xinliang Shen
Zhenglun Liang
Junzhi Wang
author_sort Qunying Mao
collection DOAJ
description Enterovirus 71 (EV71) is the major causative agent of hand, foot, and mouth disease (HFMD). Three inactivated EV71 whole-virus vaccines of different strains developed by different manufacturers in mainland China have recently entered clinical trials. Although several studies on these vaccines have been published, a study directly comparing the immunogenicity and protective effects among them has not been carried out, which makes evaluating their relative effectiveness difficult. Thus, properly comparing newly developed vaccines has become a priority, especially in China.This comparative immunogenicity study was carried out on vaccine strains (both live and inactivated), final container products (FCPs) without adjuvant, and corresponding FCPs containing adjuvant (FCP-As) produced by three manufacturers. These vaccines were evaluated by neutralizing antibody (NAb) responses induced by the same or different dosages at one or multiple time points post-immunization. The protective efficacy of the three vaccines was also determined in one-day-old ICR mice born to immunized female mice. Survival rates were observed in these suckling mice after challenge with 20 LD(50) of EV71/048M3C2. Three FCP-As, in a dose of 200 U, generated nearly 100% NAb positivity rates and similar geometric mean titers (GMTs), especially at 14-21 days post-inoculation. However, the dynamic NAb responses were different among three vaccine strains or three FCPs. The FCP-As at the lowest dose used in clinical trials (162 U) showed good protective effects in suckling mice against lethal challenge (90-100% survival), while the ED(50) of NAb responses and protective effects varied among three FCP-As.These studies establish a standard method for measuring the immunogenicity of EV71 vaccines in mice. The data generated from our mouse model study indicated 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.
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spelling doaj.art-6e9c09d3b39b4d1e8275f99823ba9f182022-12-21T20:11:43ZengPublic Library of Science (PLoS)PLoS ONE1932-62032012-01-0179e4604310.1371/journal.pone.0046043Comparative analysis of the immunogenicity and protective effects of inactivated EV71 vaccines in mice.Qunying MaoChenghong DongXiuling LiQiang GaoZengbing GuoXin YaoYiping WangFan GaoFengxiang LiMiao XuWeidong YinQihan LiXinliang ShenZhenglun LiangJunzhi WangEnterovirus 71 (EV71) is the major causative agent of hand, foot, and mouth disease (HFMD). Three inactivated EV71 whole-virus vaccines of different strains developed by different manufacturers in mainland China have recently entered clinical trials. Although several studies on these vaccines have been published, a study directly comparing the immunogenicity and protective effects among them has not been carried out, which makes evaluating their relative effectiveness difficult. Thus, properly comparing newly developed vaccines has become a priority, especially in China.This comparative immunogenicity study was carried out on vaccine strains (both live and inactivated), final container products (FCPs) without adjuvant, and corresponding FCPs containing adjuvant (FCP-As) produced by three manufacturers. These vaccines were evaluated by neutralizing antibody (NAb) responses induced by the same or different dosages at one or multiple time points post-immunization. The protective efficacy of the three vaccines was also determined in one-day-old ICR mice born to immunized female mice. Survival rates were observed in these suckling mice after challenge with 20 LD(50) of EV71/048M3C2. Three FCP-As, in a dose of 200 U, generated nearly 100% NAb positivity rates and similar geometric mean titers (GMTs), especially at 14-21 days post-inoculation. However, the dynamic NAb responses were different among three vaccine strains or three FCPs. The FCP-As at the lowest dose used in clinical trials (162 U) showed good protective effects in suckling mice against lethal challenge (90-100% survival), while the ED(50) of NAb responses and protective effects varied among three FCP-As.These studies establish a standard method for measuring the immunogenicity of EV71 vaccines in mice. The data generated from our mouse model study indicated 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.http://europepmc.org/articles/PMC3460965?pdf=render
spellingShingle Qunying Mao
Chenghong Dong
Xiuling Li
Qiang Gao
Zengbing Guo
Xin Yao
Yiping Wang
Fan Gao
Fengxiang Li
Miao Xu
Weidong Yin
Qihan Li
Xinliang Shen
Zhenglun Liang
Junzhi Wang
Comparative analysis of the immunogenicity and protective effects of inactivated EV71 vaccines in mice.
PLoS ONE
title Comparative analysis of the immunogenicity and protective effects of inactivated EV71 vaccines in mice.
title_full Comparative analysis of the immunogenicity and protective effects of inactivated EV71 vaccines in mice.
title_fullStr Comparative analysis of the immunogenicity and protective effects of inactivated EV71 vaccines in mice.
title_full_unstemmed Comparative analysis of the immunogenicity and protective effects of inactivated EV71 vaccines in mice.
title_short Comparative analysis of the immunogenicity and protective effects of inactivated EV71 vaccines in mice.
title_sort comparative analysis of the immunogenicity and protective effects of inactivated ev71 vaccines in mice
url http://europepmc.org/articles/PMC3460965?pdf=render
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