Optimal Timing of Hepatitis B Vaccination After Transplants: a Randomized Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Titer of hepatitis B surface antibodies (HBsAb).
研究概览
简要总结
The investigators aim to perform a randomized clinical trial to determine the optimal timing of hepatitis B vaccination after hematopoietic cell transplantation (HCT) through evaluating the immunity effect of two different vaccination schedules (initiated at 3 or 6 months after transplantation) in patients with different immune reconstitution status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- 否
入选标准
- •Patients must be ≥ 16 years old;
- •Patients receiving hematopoietic cell transplantation;
- •Patients achieving complete molecular remission;
- •Patients or their guardians have to sign an informed consent form before the start of the research procedure.
排除标准
- •Multiple transplantations;
- •Donors' HBV-DNA or HBsAg are positive;
- •Patients' HBV-DNA or HBsAg are positive before transplantation or < 3 months after transplantation;
- •Patients who are unable to comply with the research treatments and monitoring requirements due to mental or other medical conditions;
- •Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.
研究组 & 干预措施
'Early Vaccination' (low-risk)
Patients with composite immune risk score (CIRS) ≤ 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 3, 4, and 9 months after transplantation.
干预措施: hepatitis B vaccine (Biological)
'Early Vaccination' (high-risk)
Patients with CIRS > 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 3, 4, and 9 months after transplantation.
干预措施: hepatitis B vaccine (Biological)
'Guideline' (low-risk)
Patients with CIRS ≤ 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 6, 7, and 12 months after transplantation.
干预措施: hepatitis B vaccine (Biological)
'Guideline' (high-risk)
Patients with CIRS > 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 6, 7, and 12 months after transplantation.
干预措施: hepatitis B vaccine (Biological)
结局指标
主要结局
Titer of hepatitis B surface antibodies (HBsAb).
时间窗: One month after the completion of 3 doses of hepatitis B vaccine.
The investigators will compare the titer of HBsAb one month after the completion of 3 doses of hepatitis B vaccine in transplants with different timing of hepatitis B vaccination, different donor type and different immune reconstitution status.
次要结局
- HBV infection(Through study completion, an average of 1 year)