Neutralizing Antibody Titers 6 Years After the Third Dose of Inactivated Japanese Encephalitis Vaccine and Projected Duration of Protection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT
研究概览
简要总结
The purpose of this study is to determine whether there are persisting antibodies against Japanese Encephalitis 6 years after the last vaccination with IXIARO(R) and to adapt or confirm mathematical models accordingly.
详细描述
Japanese Encephalitis (JE) is a potentially devastating mosquito-borne viral disease. The JE virus (JEV), a Flavivirus, is endemic to many regions in Asia, and while JE is primarily a pediatric disease in the endemic regions, travelers from non-endemic regions to Asia are usually naïve to the virus and may be at risk for contracting JE at any age.
The present study aims to investigate antibody titers at approximately 6 years after the third dose of JE vaccine (JE-VC), in a cohort of participants from an earlier booster dose trial, to strengthen the statistical model of the duration of protection after the booster.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who received a booster dose of JE-VC in study IC51-311
- •Subjects who are willing to give written informed consent to participate in the trial
排除标准
- •Subjects who received a further dose of any Japanese Encephalitis Vaccine since study IC51-311
- •Severe immunosuppression (as result of medical conditions or medication) since study IC51-311, such as history of radiation therapy or cytostatic therapy
- •simultaneous participation in another clinical study
结局指标
主要结局
Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT
时间窗: 1.5 years
次要结局
- Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT(1.5 years)
研究者
Herwig Kollaritsch
Ao.Univ.-Prof. Dr.med.univ.
Medical University of Vienna