Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine（Hecolin®） in Seniors Aged Over 65 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 601
- 试验地点
- 1
- 主要终点
- Number of Participants with Serious and Non-Serious Adverse Events
研究概览
简要总结
The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
- •Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
- •Subjects will reside in the study region in the next 7 months.
- •Free of history of hepatitis E.
- •Can comply with the request of study.
- •Axillary temperature is below 37 degree centigrade.
排除标准
- •For dose 1:
- •receiving other vaccine or immunoglobulin within two weeks;
- •Having serious allergic history to vaccine and medicine
- •Eclampsia, epilepsy, encephalopathy and history of mental disease or family;
- •Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
- •Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment, genetic defect, HIV or other factors;
- •Congenital malformation, eccyliosis or severe chronic disease;
- •Fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
- •joining other clinical study undergoing;
- •women pregnant or in lactation.
- •For dose 2 or 3:
- •Severe allergy for dose 1 or 2;
- •Severe adverse reaction associated with last vaccination;
- •New occurrence of symptoms meet dose 1 exclusion criteria after the first dose.
研究组 & 干预措施
Senior group(over 65 years old)-HE
Anti-HEV IgG seronegative participants over 65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses.
干预措施: Recombinant (E. Coli) Hepatitis E Vaccine (Biological)
Younger groups(16-65 years old)
Participants aged 16-65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses.
干预措施: Recombinant (E. Coli) Hepatitis E Vaccine (Biological)
Senior group(over 65 years old)-Cont
Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention.
结局指标
主要结局
Number of Participants with Serious and Non-Serious Adverse Events
时间窗: From month 0-7
Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded.
次要结局
- anti-HEV IgG seropositive rate(at month 7)
- GMT of anti-HEV IgG(7 month after first vaccination)
研究者
Jun Zhang
professor，Xiamen University
Xiamen University