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首页> 外文期刊>The Journal of Infectious Diseases >Chimeric Live, Attenuated Vaccine against Japanese Encephalitis (ChimeriVax-JE): Phase 2 Clinical Trials for Safety and Immunogenicity, Effect of Vaccine Dose and Schedule, and Memory Response to Challenge with Inactivated Japanese Encephalitis Antig
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Chimeric Live, Attenuated Vaccine against Japanese Encephalitis (ChimeriVax-JE): Phase 2 Clinical Trials for Safety and Immunogenicity, Effect of Vaccine Dose and Schedule, and Memory Response to Challenge with Inactivated Japanese Encephalitis Antig

机译：嵌合活疫苗，减毒疫苗预防日本脑炎（ChimeriVax-JE）：安全性和免疫原性，疫苗剂量和时间表的影响以及对灭活日本脑炎Antig挑战的记忆反应的2期临床试验

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摘要

ChimeriVax-JE is a live, attenuated vaccine against Japanese encephalitis, using yellow fever (YF) 17D vaccine as a vector. In a double-blind phase 2 trial, 99 adults received vaccine, placebo, or YF 17D vaccine (YF-VAX). ChimeriVax-JE was well tolerated, with no differences in adverse events between treatment groups. Viremias resulting from administration of ChimeriVax-JE and YF-VAX were of short duration and low titer; 82 (94%) of 87 subjects administered graded doses (1.8-5.8 log(10)) of ChimeriVax-JE developed neutralizing antibodies. A second dose, administered 30 days later, had no booster effect. Previous inoculation with YF did not interfere with ChimeriVax-JE, but there was a suggestion (not statistically significant) that ChimeriVax-JE interfered with YF-VAX administered 30 days later. A separate study explored immunological memory both in subjects who had received ChimeriVax-JE 9 months before and in ChimeriVax-JE-naive subjects challenged with inactivated mouse-brain vaccine (JE-VAX). Anamnestic responses were observed in preimmune individuals. ChimeriVax-JE appears to be a safe vaccine that provides protective levels of neutralizing antibody after a single dose.
机译：ChimeriVax-JE是一种抗日本脑炎的减毒活疫苗，使用黄热病（YF）17D疫苗作为载体。在一项双盲2期试验中，有99名成年人接受了疫苗，安慰剂或YF 17D疫苗（YF-VAX）。 ChimeriVax-JE的耐受性良好，治疗组之间的不良事件无差异。施用ChimeriVax-JE和YF-VAX引起的病毒血症持续时间短，滴度低。在使用ChimeriVax-JE分级剂量（1.8-5.8 log（10））的87位受试者中，有82位（94％）开发了中和抗体。 30天后给予的第二剂没有增强作用。先前接种YF不会干扰ChimeriVax-JE，但有暗示（无统计学意义）是ChimeriVax-JE干扰了30天后施用的YF-VAX。一项单独的研究探讨了在9个月前接受过ChimeriVax-JE的受试者和接受灭活鼠脑疫苗（JE-VAX）攻击的ChimeriVax-JE天真受试者的免疫记忆。在免疫前的个体中观察到记忆消除反应。 ChimeriVax-JE似乎是一种安全的疫苗，单剂量后即可提供保护水平的中和抗体。

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