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BMC Medicine
Published in: BMC Medicine 1/2015

Open Access 01-12-2015 | Research article

Immunity and clinical efficacy of an inactivated enterovirus 71 vaccine in healthy Chinese children: a report of further observations

Authors: Longding Liu, Zhaojun Mo, Zhenglun Liang, Ying Zhang, Rongcheng Li, Kien Chai Ong, Kum Thong Wong, Erxia Yang, Yanchun Che, Jingjing Wang, Chenghong Dong, Min Feng, Jing Pu, Lichun Wang, Yun Liao, Li Jiang, Soon Hao Tan, Perera David, Teng Huang, Zhenxin Zhou, Xuanyi Wang, Jielai Xia, Lei Guo, Ling Wang, Zhongping Xie, Wei Cui, Qunying Mao, Yan Liang, Hongling Zhao, Ruixiong Na, Pingfang Cui, Haijing Shi, Junzhi Wang, Qihan Li

Published in: BMC Medicine | Issue 1/2015

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Abstract

Background

To investigate the long-term effects on immunity of an inactivated enterovirus 71 (EV71) vaccine and its protective efficacy.

Methods

A sub-cohort of 1,100 volunteers from Guangxi Province in China was eligible for enrolment and randomly administered either the EV71 vaccine or a placebo on days 0 and 28 in a phase III clinical trial and then observed for the following 2 years with approval by an independent ethics committee of Guangxi Zhuang Autonomous Region, China. Serum samples from the 350 participants who provided a full series of blood samples (at all the sampling points) within the 2-year period were collected. Vaccine-induced immune effects, including the neutralizing antibody titres and cross-protection against different genotypes of EV71, were examined. This study also evaluated the protective efficacy of this vaccine based upon clinical diagnosis.

Results

This sub-cohort showed a >60 % drop-out rate over 2 years. The seroconversion rates among the 161 immunized subjects remained >95 % at the end of study. The geometric mean titres of neutralizing antibodies (anti-genotype C4) 360 days after vaccination in 350 subjects were 81.0 (subjects aged 6–11 months), 98.4 (12–23 months), 95.0 (24–35 months), and 81.8 (36–71 months). These titres subsequently increased to 423.1, 659.0, 545.0, and 321.9, respectively, at 540 days post-immunization (d.p.i.), and similar levels were maintained at 720 d.p.i. Higher IFN-γ/IL-4-specific responses to the C4 genotype of EV71 and cross-neutralization reactivity against major EV71 genotype strains were observed in the vaccine group compared to those in the placebo group. Five EV71-infected subjects were observed in the placebo-treated control group and none in the vaccine-immunized group in per-protocol analysis.

Conclusion

These results are consistent with the induction of dynamic immune responses and protective efficacy of the vaccine against most circulating EV71 strains.

Trial registration number

Clinicaltrials.gov, NCT01569581, Trial registration date: March 2012
Appendix
Available only for authorised users
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Metadata
Title
Immunity and clinical efficacy of an inactivated enterovirus 71 vaccine in healthy Chinese children: a report of further observations
Authors
Longding Liu
Zhaojun Mo
Zhenglun Liang
Ying Zhang
Rongcheng Li
Kien Chai Ong
Kum Thong Wong
Erxia Yang
Yanchun Che
Jingjing Wang
Chenghong Dong
Min Feng
Jing Pu
Lichun Wang
Yun Liao
Li Jiang
Soon Hao Tan
Perera David
Teng Huang
Zhenxin Zhou
Xuanyi Wang
Jielai Xia
Lei Guo
Ling Wang
Zhongping Xie
Wei Cui
Qunying Mao
Yan Liang
Hongling Zhao
Ruixiong Na
Pingfang Cui
Haijing Shi
Junzhi Wang
Qihan Li
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Medicine / Issue 1/2015
Electronic ISSN: 1741-7015
DOI
https://doi.org/10.1186/s12916-015-0448-7

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