Long-term immunogenicity and immune persistence of live attenuated and inactivated hepatitis a vaccines: a report on additional observations from a phase IV study
作者: J. LuoX. WangF. MaG. KangZ. DingC. YeY. PanY. ZhaoS. HongJ. ChenJ. XiS. WenY. LinX. LiL. QiuX. YangG. LiJ. YangQ. Sun
作者单位: 1Institute of Medical Biology, Chinese Academy of Medical Sciences, Peking Union Medical College, Kunming, China
2Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, China
3Yunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, China
4Kunming Medical University Haiyuan College, Kunming, China
5Jiangsu Provincial Centre of Disease Control and Prevention, Nanjing, China
6Yunnan Provincial Centre of Disease Control and Prevention, Kunming, Yunnan Province, China
7Kunming Medical University, Kunming, China
8The Affiliated Children's Hospital of Kunming Medical University, Kunming, China
刊名: Clinical Microbiology and Infection, 2019, Vol.25 (11), pp.1422-1427
来源数据库: Elsevier Journal
DOI: 10.1016/j.cmi.2018.11.005
关键词: Hepatitis a vaccinesHepatitis a virusImmune persistenceImmunogenicityPhase IV study
英文摘要: Abstract(#br)Both live attenuated (HA-L) and inactivated (HA-I) hepatitis A vaccine were licensed for routine use in China. Although phase 1, 2 and 3 clinical studies of both vaccines have been completed, further systematic evaluation of their immunogenicity and immunological persistence under phase 4 clinical studies in a wide range of conditions and involving large populations is necessary. A phase IV clinical trial (NCT02601040) was performed in 9000 participants over 18 months of age. Geometric mean concentrations (GMCs) and seroconversion rates (SRs) were compared at five time points during 3 years for 1800 individuals among them. The SRs of HA-L and HA-I were 98.08% (95% CI 95.59%–99.38%) and 99.64% (95% CI 98.93%–100.00%) respectively 28 days after administration of the first dose,...
全文获取路径: Elsevier  (合作)
分享到:

×
关键词翻译
关键词翻译
  • immunogenicity 致免疫性
  • immune 免疫的
  • vaccines 疫苗
  • attenuated 减毒的
  • hepatitis 肝炎
  • persistence 余辉时间
  • additional 追加的
  • report 通报
  • phase 相位
  • study 学习