JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

A booster dose of an inactivated enterovirus 71 vaccine in chinese young children: a randomized, double-blind, placebo-controlled clinical trial

Wang Shenyu, Li Jingxin, Liang Zhenglun, Li Xiuling, Mao Qunying, Meng Fanyue, Wang Hua, Zhang Yuntao, Gao Fan, Chen Qinghua, Hu Yuemei, Yao Xin, Guo Huijie, Zhu Fengcai
Journal of Infectious Diseases 2014 October 1, 210 (7): 1073-82
24625805

BACKGROUND: A significant waning of enterovirus 71 (EV71) antibody titer after priming immunization with an inactivated EV71 vaccine implied the potential need for a booster dose.

METHODS: In this randomized, double-blind, placebo-controlled clinical trial, we recruited participants who had received at least 1 dose of priming EV71 vaccine in an early phase 2 clinical trial that was conducted in healthy infants and children aged 6-35 months. All participants were grouped according to the priming EV71 vaccine formulations (160 U, 320 U, and 640 U with adjuvant and 640 U without adjuvant) and then randomly assigned (ratio, 2:1) to receive a booster dose of vaccine or placebo within each formulation group. The primary end point was the geometric mean titer 28 days after the booster dose.

RESULTS: A total of 773 participants were enrolled. Significantly greater immunological responses were induced by the booster shot of all 4 formulations of EV71 vaccine, compared with that induced by placebo (P < .0001). The frequencies of adverse reactions were similar between vaccine and placebo groups within each formulation group.

CONCLUSIONS: A booster dose of EV71 vaccine 1 year after the priming EV71 immunization shows excellent immunogenicity and good safety profile. Clinical Trials Registration: NCT01734408.

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