Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Feng-Cai Zhu, Fan-Yue Meng, Jing-Xin Li, Xiu-Ling Li, Qun-Ying Mao, Hong Tao, Yun-Tao Zhang, Xin Yao, Kai Chu, Qing-Hua Chen, Yue-Mei Hu, Xing Wu, Pei Liu, Lin-Yang Zhu, Fan Gao, Hui Jin, Yi-Juan Chen, Yu-Ying Dong, Yong-Chun Liang, Nian-Min Shi, Heng-Ming Ge, Lin Liu, Sheng-Gen Chen, Xing Ai, Zhen-Yu Zhang, Yu-Guo Ji, Feng-Ji Luo, Xiao-Qin Chen, Ya Zhang, Li-Wen Zhu, Zheng-Lun Liang, Xin-Liang Shen
Lancet 2013 June 8, 381 (9882): 2024-32

BACKGROUND: A vaccine for enterovirus 71 (EV71) is needed to address the high burden of disease associated with infection. We assessed the efficacy, safety, immunogenicity, antibody persistence, and immunological correlates of an inactivated alum-adjuvant EV71 vaccine.

METHODS: We did a randomised, double-blind, placebo-controlled, phase 3 trial. Healthy children aged 6-35 months from four centres in China were randomly assigned (1:1) to receive vaccine or alum-adjuvant placebo at day 0 and 28, according to a randomisation list (block size 30) generated by an independent statistician. Investigators and participants and their guardians were masked to the assignment. Primary endpoints were EV71-associated hand, foot, and mouth disease (HFMD) and EV71-associated disease during the surveillance period from day 56 to month 14, analysed in the per-protocol population. This study is registered with, number NCT01508247.

FINDINGS: 10,245 participants were enrolled and assigned: 5120 to vaccine versus 5125 to placebo. 4907 (with three cases of EV71-associated HFMD and eight cases of EV71-associated disease) versus 4939 (with 30 cases of EV71-associated HFMD and 41 cases of EV71-associated disease) were included in the primary efficacy analysis. Vaccine efficacy was 90·0% (95% CI 67·1-96·9) against EV71-associated HFMD (p=0·0001) and 80·4% (95% CI 58·2-90·8) against EV71-associated disease (p<0·0001). Serious adverse events were reported by 62 of 5117 (1·2%) participants in the vaccine group versus 75 of 5123 (1·5%) in the placebo group (p=0·27). Adverse events occurred in 3644 (71·2%) versus 3603 (70·3%; p=0·33).

INTERPRETATION: EV71 vaccine provides high efficacy, satisfactory safety, and sustained immunogenicity.

FUNDING: China's 12-5 National Major Infectious Disease Program, Beijing Vigoo Biological.

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