NCT01813487已完成不适用
Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy in Patients Who Have Been Treated With HB110E Hepatitis B DNA Vaccine
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Immunogenicity: HBV specific T-cell response by ELISPOT
研究概览
简要总结
The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects who have been treated with HB110E 2mg or 4mg within 6 months prior to screening.
- •positive HBsAg at screening
- •serum HBV DNA level below 300copies/mL at screening
- •ALT level within 2 x ULN at screening
- •voluntarily provide the informed consent
排除标准
- •participation in other study within 30 days of screening
- •subjects with severe allergic reaction or severe adverse event to HBsAg vaccine, or not suitable for HBsAg vaccine.
- •any other conditions that are considered inappropriate for the study by the investigator
研究组 & 干预措施
HBsAg vaccine with Entecavir
Other
干预措施: HBsAg vaccine with Entecavir (Drug)
结局指标
主要结局
Immunogenicity: HBV specific T-cell response by ELISPOT
时间窗: Change from Baseline in HBV specificic T-cell response at 16 weeks
sample for immunologic assay will be collected at each visit; VS(\~4week), VT1(0week), VT2(8week), VF(16week. T-cell response will be measured by ex-vivo \& cultured ELISPOT.
次要结局
- HBsAg titer(Change from baseline in HBsAg titer at 16 weeks)
研究者
研究点 (1)
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