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Neutralizing antibody persistence in pediatric travelers from non-JE-endemic countries following vaccination with IXIARO® Japanese encephalitis vaccine: An uncontrolled, open-label phase 3 follow-up study.
Travel Medicine and Infectious Disease ( IF 12.0 ) Pub Date : 2020-03-07 , DOI: 10.1016/j.tmaid.2020.101616
Christian Taucher 1 , Elizabeth D Barnett 2 , Jakob P Cramer 3 , Susanne Eder-Lingelbach 1 , Tomas Jelinek 4 , Vera Kadlecek 1 , Sigrid Kiermayr 1 , Deborah J Mills 5 , Duellyn Pandis 6 , Daniela Reiner 1 , Katrin L Dubischar 1
Affiliation  

Background

In an initial study among children from non-Japanese encephalitis (JE)-endemic countries, seroprotection rates remained high 6 months after completion of the primary series with IXIARO®.

Methods

In this open-label follow-up study, a subset of 23 children who received a 2-dose primary series of IXIARO® in the parent study, were evaluated for safety and neutralizing antibody persistence for 36 months.

Results

Seroprotection rates (SPRs) remained high but declined from 100% one month after primary immunization to 91.3% at month 7 and 89.5% at month 36. Geometric mean titers (GMTs) declined considerably from 384.1 by day 56–60.8 at month 36. No long-term safety concerns were identified.

Conclusions

The substantial decline in GMT observed in this study, together with previously published data on children vaccinated with IXIARO® support the recommendation for a booster dose in children who remain at risk of JE from 1 year after the primary series of IXIARO®, consistent with the recommendation for adults.

Clinical trial registry number

NCT01246479.



中文翻译:

接种IXIARO®日本脑炎疫苗后,来自非JE流行国家的儿科旅行者的中和抗体持续存在:一项不受控制的,开放标签的3期随访研究。

背景

在非流行性乙型脑炎(乙脑)-endemic国家儿童中的初步研究,血清保护率的主要系列IXIARO结束6个月后仍保持高®

方法

在这项开放性随访研究,谁收到了23名儿童的一个子集2剂主要系列IXIARO的®在代研究,进行安全性和中和抗体持久性36个月评估。

结果

血清保护率(SPR)仍然很高,但从初次免疫后一个月的100%下降到第7个月的91.3%和第36个月的89.5%。几何平均滴度(GMT)从第36天的564.1至第38天的384.1大幅下降。确定了长期安全隐患。

结论

在格林尼治标准时间的大幅下降与本研究与IXIARO接种疫苗的儿童此前公布的数据观察到,一起®支持儿童加强剂量谁留在JE的风险由1年的主要系列IXIARO后推荐®,与一致成人推荐。

临床试验注册号

NCT01246479。

更新日期:2020-03-07
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