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

BMC Medicine

Qihan Li⁴  Junzhi Wang²  Haijing Shi⁴  Pingfang Cui⁴  Ruixiong Na⁴  Hongling Zhao⁴  Yan Liang⁴  Qunying Mao²  Wei Cui⁴  Zhongping Xie⁴  Ling Wang⁷  Lei Guo⁴  Jielai Xia⁷  Xuanyi Wang³  Zhenxin Zhou⁴  Teng Huang⁵  Perera David⁶  Soon Hao Tan¹  Li Jiang⁸  Yun Liao⁴  Lichun Wang⁴  Jing Pu⁴  Min Feng⁴  Chenghong Dong⁴  Jingjing Wang⁴  Yanchun Che⁴  Erxia Yang⁸  Kum Thong Wong¹  Kien Chai Ong¹  Rongcheng Li⁵  Ying Zhang⁴  Zhenglun Liang²  Zhaojun Mo⁵  Longding Liu⁴ 

[1] Departments of Biomedical Science and Pathology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia;National Institutes for Food and Drug Control, Beijing, China;Key Laboratory of Medical Molecular Virology, Ministries of Education and Health, Institute of Biological Sciences, Shanghai Medical College, Fudan University, Shanghai, China;Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China;Guangxi Province Centres for Disease Control and Prevention, Nanning, China;Institute of Health & Community Medicine, University Malaysia Sarawak, Kuala Lumpur, Malaysia;Department of Health Statistics, Fourth Military Medical University, Xi’an, China;Jiangsu Convac Biotechnology Co., Ltd, Taizhou, Jiangsu, China

关键词: Long-term effect;    Inactivated vaccine;    and mouth disease;    foot;    Hand;    Enterovirus 71;    Cross-neutralization;   

Others  :  1226301
DOI  :  10.1186/s12916-015-0448-7

 received in 2015-03-30, accepted in 2015-08-12,  发布年份 2015

【 摘 要 】

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

【 授权许可】

   
2015 Liu et al.

【 图 表 】

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