Hepatitis B Vaccination in Liver Transplant Reecipients Who Received a Liver From an Anti-core Positive Donor. H
试验速览
- 阶段
- 2 期
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Response to HBV vaccine
研究概览
简要总结
Anti-HBc positive liver donors frequently have occult HBV infection, and several studies in HBsAg-negative subjects have shown that there is often the detection in the liver of covalently closed circular DNA (cccDNA). In the setting of liver transplantation and immunosuppresion, grafts from antiHBc positive donors may cause de novo HBV infection (defined by the development of positive HBsAg and/or detectable serum or liver HBV DNA in previously HBsAg recipients).
Active immunization may be successful in up to 20% of patients who received an anti-HBc+ liver during transplantation after the first vaccination schedule, and up to 30% after a second vaccination course. Responders to vaccination could safely halt nucleos(t)ide analog prophylactic therapy with no risk of HBV reactivation during follow-up.
We also hypothesize that an impaired antigen-specific adaptive cell-mediated immunity at baseline explain the lack of response
Primary objective:
- To investigate the efficacy of HBV vaccination in liver transplant recipients who received a liver from an anti-HBc positive donor.
- To assess the safety of nucleos(t)ide treatment interruption in those patients achieving a response to HBV vaccination
详细描述
HYPOTHESIS The hypothesis of the study is that active immunization may be successful in up to 20% of patients who received an anti-HBc+ liver during transplantation after the first vaccination schedule, and up to 30% after a second vaccination course. Responders to vaccination could safely halt nucleos(t)ide analog prophylactic therapy with no risk of HBV reactivation during follow-up.
Thus, an impaired antigen-specific adaptive cell-mediated immunity at baseline may explain the lack of response.
OBJECTIVES
Primary objective:
- To investigate the efficacy of HBV vaccination in liver transplant recipients who received a liver from an anti-HBc positive donor.
- To assess the safety of nucleos(t)ide treatment interruption in those patients achieving a response to HBV vaccination
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years- old.
- •HBsAg-negative pre-transplantation
- •Liver transplant recipients; more than 2 years from the date of LT
- •Transplantation of a graft from an HBV anti-core positive donor
- •Patients should be under nucleoside analogue therapy with Lamivudine, Tenofovir or Entecavir
- •Stable immunosuppressive therapy during the last 6 months
- •Baseline anti-HBs levels <100 IU/L (HBV vaccination while on the waiting list is allowed and will be recorded)
- •Willingness to participate in the study and written inform consent
排除标准
- •• HBsAg positive at any time post-transplantation
- •HBV-DNA positive at any time post-transplantation
- •Any HBIG dose during the last 12 months
- •HBV vaccination after liver transplantation
- •Spontaneous or vaccine-induced post-transplant anti-HBs titers ≥ 100 UI/L
- •Any rejection episode during the last 12 months
- •Positive HCV-RNA at time of vaccination
- •HCV therapy with direct acting antivirals within the previous 12 months
- •HIV coinfection
- •Advanced fibrosis after LT (liver stiffness measurement ≥ 9.5 kPa)
- •Pregnancy
结局指标
主要结局
Response to HBV vaccine
时间窗: 1 month after last HBV vaccine dose
\> 100 IU/mlL anti-HBs
Incidence of Emergent Adverse Events in case of nucleos(t)ide analogue (NUC) treatment interruption
时间窗: 6 months after NUC interruption
No reactivation of HBV (negative HBV-DNA) 6-12 months after NUC interruption
次要结局
未报告次要终点