jRCTs061180101已完成不适用
Phase I/II clinical trial of HB vaccine containing HBsAg and HBcAg for prophylaxis (HepBVac-J2)
未提供0 个研究点目标入组 100 人开始时间: 2017年1月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 65age old under（—）
- 性别
- All
入选标准
- •Healthy individuals agreed to participate in this trial after obtaining writen informed consent
- •a) HB vaccine naive: No pasthistory of HB vaccination
- •b) HB vaccine responder: Anti-HBs > 10mIU/mL after HB vaccination
- •c) HB vaccine non-responder: Anti-HBs < 10mIU/mL after HB vaccination
- •(1) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
- •(2) No evidence of organ dysfunction
- •Liver: Child-Pugh Score < 9
- •Kidney: eGFR > 30ml/min
- •Heart: No abnormality in ECG
- •Lung: SpO2 >92%
排除标准
- •(1) Allergic history against past vaccination
- •(2) Pregnant, unwilling to practice contraception during the study or lactating female
- •(3) Severe complication (malignant hypertension, severe congestive heart failure, severe liver failure, poorly controlled diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonia)
- •(4) Bearing malignant carcinoma including HCC
- •(5) Severe mental disability
- •(6) Positive for HCV-RNA
- •(7) Taking immunosuppressive drugs, steroid and interferons
- •(8) Inappropriate to participate in this trial
结局指标
主要结局
-
Anti-HBs induction
次要结局
未报告次要终点
研究者
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