title: Reactogenicity and immunogenicity of an enterovirus 71 vaccine in Chinese healthy children and infants.
abstract: 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.
authors.affiliation: Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu Province, People's Republic of China. jszfc@vip.sina.com
authors.forename: Feng-Cai
authors.initials: FC
authors.lastname: Zhu
authors.forename: Jun-Zhi
authors.initials: JZ
authors.lastname: Wang
authors.forename: Xiu-Ling
authors.initials: XL
authors.lastname: Li
authors.forename: Zheng-Lun
authors.initials: ZL
authors.lastname: Liang
authors.forename: Heng-Ming
authors.initials: HM
authors.lastname: Ge
authors.forename: Fan-Yue
authors.initials: FY
authors.lastname: Meng
authors.forename: Qun-Ying
authors.initials: QY
authors.lastname: Mao
authors.forename: Yun-Tao
authors.initials: YT
authors.lastname: Zhang
authors.forename: Zhen-Yu
authors.initials: ZY
authors.lastname: Zhang
authors.forename: Hong
authors.initials: H
authors.lastname: Ji
authors.forename: Fan
authors.initials: F
authors.lastname: Gao
authors.forename: Hui-Jie
authors.initials: HJ
authors.lastname: Guo
authors.forename: Qi-Yan
authors.initials: QY
authors.lastname: Zhu
authors.forename: Kai
authors.initials: K
authors.lastname: Chu
authors.forename: Xing
authors.initials: X
authors.lastname: Wu
authors.forename: Jing-Xin
authors.initials: JX
authors.lastname: Li
authors.forename: Qing-Hua
authors.initials: QH
authors.lastname: Chen
authors.forename: Xiao-Qin
authors.initials: XQ
authors.lastname: Chen
authors.forename: Wei-Wei
authors.initials: WW
authors.lastname: Zhang
authors.forename: Yue-Mei
authors.initials: YM
authors.lastname: Hu
authors.forename: Liang
authors.initials: L
authors.lastname: Li
authors.forename: Feng-Xiang
authors.initials: FX
authors.lastname: Li
authors.forename: Xin
authors.initials: X
authors.lastname: Yao
authors.forename: Pei
authors.initials: P
authors.lastname: Liu
authors.forename: Hua
authors.initials: H
authors.lastname: Wang
authors.forename: Xin-Liang
authors.initials: XL
authors.lastname: Shen
mesh_terms: D044466:Asian People; D002675:Child, Preschool; D004311:Double-Blind Method; D029821:Enterovirus A, Human / Q000276:immunology*; D004769:Enterovirus Infections / Q000517:prevention & control*; D006801:Humans; D007223:Infant; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology*
chemical_list: D014765:Viral Vaccines