在非日本脑炎流行国家的儿科人群中使用 Vero 细胞来源的灭活日本脑炎疫苗（IXIARO，JESPECT）的安全性和免疫原性：一项非对照、开放性 3 期研究。
Safety and immunogenicity of an inactivated Vero cell_derived Japanese encephalitis vaccine (IXIARO, JESPECT) in a pediatric population in JE non-endemic countries: An uncontrolled, open-label phase 3 study.
机构信息
Berlin Center for Travel & Tropical Diseases, Berlin and Institute of Medical Microbiology, Immunology and Hygiene, University of Cologne, Germany.
Tampa Clinical Research, Inc., Tampa, FL, USA.
出版信息
Travel Med Infect Dis. 2018 Mar-Apr;22:18-24. doi: 10.1016/j.tmaid.2018.03.003. Epub 2018 Mar 13.
BACKGROUND
Young travelers to South-East Asia may be at risk for Japanese encephalitis (JE).
METHODS
IXIARO (0.25 ml or 0.5 ml, depending on age) were administrated to 100 travelers aged ≥ 2 months to < 18 years. Solicited AEs were collected for 7 days after each injection, unsolicited adverse events (AEs) for a total of 7 months. JE neutralizing antibodies were assessed in 64 subjects.
RESULTS
The most common solicited local AEs were redness (3/12 subjects), induration and tenderness (both 1/12) with 0.25 ml IXIARO, and tenderness (44/88) and pain (22/88) with 0.5 ml IXIARO. Common solicited systemic AEs were diarrhea (2/12) and loss of appetite (1/12) with 0.25 ml IXIARO and muscle pain (27/88) and excessive fatigue (10/88) with 0.5 ml IXIARO. In total, up to day 56, AEs were reported by 10/12 (83.3%) of subjects who received the 0.25 ml dose and 67/88 (76.1%) of those vaccinated with the 0.5 ml dose. All subjects (62/62; 100%) developed protective levels of JE neutralizing antibodies by Day 56 and 31/34 (91.2%) retained protective titers at Month 7.
CONCLUSIONS
IXIARO was generally well tolerated in children, with an overall AE profile similar to adults. IXIARO was highly immunogenic in both dose groups.
背景
前往东南亚的年轻旅行者可能有感染日本脑炎（JE）的风险。
方法
根据年龄，为 100 名年龄在 2 个月至 18 岁以下的旅行者接种了 Ixiaro（0.25ml 或 0.5ml）。每次接种后 7 天内收集有症状的不良反应（AE），7 个月内总收集无症状的不良反应（AE）。评估了 64 名受试者的 JE 中和抗体。
结果
最常见的有症状局部不良反应是发红（3/12 例）、硬结和触痛（均为 1/12 例），使用 0.25ml Ixiaro，0.5ml Ixiaro 常见的有症状局部不良反应是触痛（44/88 例）和疼痛（22/88 例）。常见的有症状全身不良反应是腹泻（2/12 例）和食欲不振（1/12 例），使用 0.25ml Ixiaro，0.5ml Ixiaro 常见的有症状全身不良反应是肌肉疼痛（27/88 例）和过度疲劳（10/88 例）。在总共 56 天内，接受 0.25ml 剂量的 12 名受试者中有 10 名（83.3%）和接种 0.5ml 剂量的 88 名受试者中有 67 名（76.1%）报告了不良反应。所有受试者（62/62；100%）在第 56 天产生了保护性的 JE 中和抗体水平，31/34 名（91.2%）在第 7 个月保留了保护性滴度。
结论
Ixiaro 在儿童中通常具有良好的耐受性，总体不良反应谱与成人相似。在两个剂量组中，Ixiaro 均具有高度的免疫原性。
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