Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: A randomized, placebo-controlled, double-blind, Phase I clinical trial

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• 作者：Yan-Ping Li^a ; ¹ ; Zheng-Lun Liang^b ; ¹ ; Qiang Gao^c ; ¹ ; Li-Rong Huang^a ; Qun-Ying Mao^b ; Shu-Qun Wen^a ; Yan Liu^c ; Wei-Dong Yin^c ; Rong-Cheng Li^a ; Jun-Zhi Wang^b ; ^{wangjz@nicpbp.org.cn}
• 关键词：Enterovirus 71 ; EV71 vaccine ; Safety ; Immunogenicity
• 刊名：Vaccine
• 出版年：2012
• 期刊代码：89_0264410x
• 类别：imm
• 出版时间：9 May, 2012
• 卷：30
• 期：22
• 页码：3295-3303
• 文件大小：541 K

摘要

There is an urgent need for a novel vaccine that is effective against human Enterovirus 71 (EV71) outbreaks. A double-blind, randomized controlled study was to evaluate the safety and immunogenicity of a human EV71 vaccine in healthy adults, children and infants. The vaccine dosages were 200 U and 400 U for children and adults, and 100 U, 200 U and 400 U for infants. Subjects were randomized to receive different dosages of the vaccine or placebo. Adults received intramuscular injection on Days 0, 14 and 28. Children and Infants received on Days 0, 28 and 56. The novel human EV71 inactivated vaccine was well tolerated and highly immunogenic in healthy volunteers, especially in infant populations. For immune response, the seropositive rates (with titers 鈮モ墺1:8) of neutralizing antibody [NTAb] increased to 100%for all dosage groups after the second vaccination. For NTAb seronegative infants before vaccination, after one dose, the NTAb GMTs were 29.7 (95%CI, 13.1-67.2), 10.1 (95%CI, 6.6-15.3), and 27.4 (95%CI, 14.3-52.2) in the 100 U, 200 U, and 400 U vaccine groups, respectively; after two doses, the GMTs were 114.1 (95%CI, 44.5-292.4), 159.5 (95%CI, 49.3-515.3), and 509.0 (95%CI, 181.3-1429.1), respectively.

Trial registration: ClinicalTrial.gov identifier: and .