一种新型单剂量减毒活疫苗在成人中的免疫原性、安全性和耐受性：随机对照 3 期临床试验。
Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials.
机构信息
Department of Infectious Diseases, Austin Hospital, Heidelberg, Victoria, Australia.
出版信息
Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.
Japanese encephalitis chimeric virus vaccine (JE-CV) was developed to replace licensed mouse brain-derived vaccine (MBD-JE), the production of which ceased in 2005. Two randomised controlled phase 3 studies were conducted. Immunogenicity study: 410 participants received one JE-CV injection, 410 received 3 MBD-JE injections. Safety study: 1,601 participants received JE-CV, 403 received placebo. Seroconversion after a single JE-CV vaccination (99.1%) was statistically non-inferior to that after three-dose MBD-JE (95.1%) vaccination. JE-CV elicited a rapid immune response, with 93.6% of participants seroconverting within 14 days. Adverse reaction rates were significantly lower with JE-CV (67.6%) than with MBD-JE (82.2%) (p<0.001), and the reactogenicity profile of JE-CV was comparable with that of placebo. A single dose of JE-CV elicited rapid seroconversion in a higher proportion of vaccinees than the current vaccine with fewer reactions. The safety profile of JE-CV is good.
日本脑炎嵌合病毒疫苗（JE-CV）的开发旨在替代 2005 年停产的许可鼠脑源性疫苗（MBD-JE）。进行了两项随机对照 3 期研究。免疫原性研究：410 名参与者接受单次 JE-CV 注射，410 名参与者接受 3 次 MBD-JE 注射。安全性研究：1601 名参与者接受 JE-CV，403 名参与者接受安慰剂。单次 JE-CV 接种后的血清转化率（99.1%）在统计学上不低于 3 剂 MBD-JE（95.1%）接种后的血清转化率。JE-CV 引起快速免疫反应，93.6%的参与者在 14 天内血清转化。JE-CV 的不良反应发生率明显低于 MBD-JE（67.6%对 82.2%）（p<0.001），且 JE-CV 的反应原性与安慰剂相当。JE-CV 单次接种后，疫苗接种者的血清转化率高于目前的疫苗，且不良反应更少。JE-CV 的安全性良好。
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