HBV Vaccine in Anti-core Positive Donors After LT

Summary

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: 1. To investigate the efficacy of HBV vaccination in liver transplant recipients who received a liver from an anti-HBc positive donor. 2. To assess the safety of nucleos(t)ide treatment interruption in those patients achieving a response to HBV vaccination

Timeline

Start

2020-09

Primary completion

2022-01

Completion

2023-01

Drugs

Indications