Effect of Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg-a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in HBsAg Levels From Baseline to 2 Years
研究概览
简要总结
Background:
The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance. There is a good chance to further increase the cure rate if the investigators can enhance the HBV-specific immune response when the HBsAg level already comes to a low level.
Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients whose HBsAg already <=2000 IU/ml.
Patients and methods:
This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine (20μg for <20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each dose during the treatment period and every 3 months for another year following the last dose. Viral and cellular factors will be studied to discover determinants affecting HBsAg clearance.
Aims
- To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate chronic HBV infection in patients with low titer HBsAg.
- To delineate the doses to response (HBsAg clearance or decline rate) correlation so as to design a feasible schedule for future clinical trials in a larger group of patients.
- To discover viral and host factors which can be used as biomarkers for personalized vaccine therapy.
详细描述
Vaccination schedule:
Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) will be administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months or until HBsAg clearance. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old.
HBsAg and anti-HBs:
qHBsAg will be checked by commercial kits (Elecsys, Roche Diagnostics, Indianapolis, IN) at baseline, right before every dose, and every 3 months following the last dose for one year. ALT, AST, Alpha-fetoprotein, bilirubin and anti-HBs will be checked simultaneously.
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
- 3 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Naïve or treated chronic hepatitis B patients with positive HBsAg and negative HBeAg;
- •Quantitative serum HBsAg (qHBsAg) <2000 IU/ml;
- •No HIV co-infection;
- •No obvious immunodeficiency (such as renal failure, chemotherapy, radiotherapy, immunosuppressant);
- •Aged 3 to 80 years;
排除标准
- •Allergic to HBV vaccine or yeast.
- •Hepatic decompensation
结局指标
主要结局
Change in HBsAg Levels From Baseline to 2 Years
时间窗: 2 years
The difference of HBsAg levels at the end of follow up (2 years) and baseline
次要结局
- Anti-HBs Seropositivity(2 years)
研究者
Ming-Wei Lai
M.D., Ph.D.
Chang Gung Memorial Hospital