MedTrace Logo

HBV Vaccine in Anti-core Positive Donors After LT

NCT04442841 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2020-07-31

No results posted yet for this study

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

Conditions

  • Hepatitis B Reactivation

Interventions

BIOLOGICAL

Hepatitis B vaccine

It may be GSk or MSD vaccine

Sponsors & Collaborators

  • University of Padova

    collaborator OTHER

  • Hospital Vall d'Hebron

    collaborator OTHER

  • Hospital Clinic of Barcelona

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2022-01-31
Completion
2023-01-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04442841 on ClinicalTrials.gov