JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

Reactogenicity and immunogenicity of an enterovirus 71 vaccine in Chinese healthy children and infants

Feng-Cai Zhu, Jun-Zhi Wang, Xiu-Ling Li, Zheng-Lun Liang, Heng-Ming Ge, Fan-Yue Meng, Qun-Ying Mao, Yun-Tao Zhang, Zhen-Yu Zhang, Hong Ji, Fan Gao, Hui-Jie Guo, Qi-Yan Zhu, Kai Chu, Xing Wu, Jing-Xin Li, Qing-Hua Chen, Xiao-Qin Chen, Wei-Wei Zhang, Yue-Mei Hu, Liang Li, Feng-Xiang Li, Xin Yao, Pei Liu, Hua Wang, Xin-Liang Shen
Pediatric Infectious Disease Journal 2012, 31 (11): 1158-65
22926209

BACKGROUND: Enterovirus 71 (EV71) is highly contagious and can cause severe complications. A safe and effective vaccine is needed. We assessed the reactogenicity and immunogenicity of an inactivated, alum-adjuvanted EV71 vaccine in this study.

METHODS: A randomized, double-blind, placebo-controlled clinical trial was undertaken in 360 healthy participants who were stratified into 2 age groups (6-12 and 13-60 months), and randomly allocated to receive placebo or the investigational vaccine containing 160 U, 320 U or 640 U antigen per dose by the ratio of 1:1:1:1 at days 0 and 28. Reactogenic data within 28 days after each vaccination were recorded. Blood samples were obtained on days 0, 28 and 56 for neutralizing antibody assay.

RESULTS: Overall, 193 participants reported at least 1 injection-site or systemic adverse reaction with 53.3% and 54.4% participants receiving the study vaccine and placebo, respectively. Most of the reactions were mild or moderate. Three serious adverse events were observed, but none was related to vaccination. In the participants with seronegative baseline, after 2 doses all the participants receiving EV71 vaccines were seropositive and the seroconversion rates were more than 98.1%. In the participants with seropositive baseline, 1 dose induced good seroconversion rates of more than 64.3% in participants receiving EV71 vaccines.

CONCLUSIONS: This study found that the inactivated EV71 vaccine was well tolerated and had good immunogenicity in healthy children and infants. A single dose induced typical booster response in the participants with a seropositive baseline, and 2 doses were needed for the immunologically naive participants.

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