Non-comparable and Open Clinical Research to Evaluate Long-term Immunity by Neutralizing Antibody Test of Adults in High Risk Population of HFRS (Hemorrhagic Fever With Renal Syndrome) After Vaccination and Booster Vaccination of Hantavax
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 226
- 主要终点
- Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates
研究概览
简要总结
This study was aimed evaluate long-term immunity response by neutralizing antibody test of adults in high risk population of HFRS .
详细描述
This clinical trial was designed as a multicenter, non-comparable, open-label clinical trial.This trial was conducted written informed consent form by voluntary agreement, negative result of hantaanvirus antubidy by neutralizaing antibody test, test drug was administrated 0, 1, 13 months according to drug label.
For antibody test, Sampling was conducted pre-dose(T0), 1 month after vaccination(T1), 1 year after vaccination(before booster vaccination, T2) and 1 month after vaccination(T3). Also, 1 month after vaccination (T3) after completion of booster vaccination for antibody retension duration observed for subjects with antibody to conduct a three-year follow-up survey was conducted, and the antibody test every year.In conclusion, sampling was conducted 12 months(T4), 24 months(T5), 36months(T6) after the booster vaccionation.
However, follow-up survey was terminated when the antibody titer was determined as a negative by neutralizing antibody test and fluorescent antibody technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subjects who have the vaccination history of ah the time of screening
- •The subjects whose Hantaan virus virus's antibody shows negative using Neutralizing antibody test at the time of screening
排除标准
- •The subjects who have a history of hemorrhagic fever with renal syndrome
- •The subjects who have a fever or significant dystrophy
研究组 & 干预措施
hantaan virus vaccine
干预措施: Hantavax injection (Drug)
结局指标
主要结局
Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates
时间窗: 13 months
次要结局
- The antibody seroconversion rates and its retension rates by neutralizing antibody test(13 months)
- The antibody seroconversion rates and its retension rates by fluorescent antibody technique(13 months)
- The antibody titers by neutralizing antibody test and fluorescent antibody technique(13 months)
- Number of adverse events after vaccination of Hantavax to adults in high risk population.(3 years)