NCT04442841

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 31, 2020

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

June 19, 2020

Last Update Submit

July 30, 2020

Conditions

Hepatitis B Reactivation

Outcome Measures

Primary Outcomes (2)

  • Response to HBV vaccine

    \> 100 IU/mlL anti-HBs

    1 month after last HBV vaccine dose

  • Incidence of Emergent Adverse Events in case of nucleos(t)ide analogue (NUC) treatment interruption

    No reactivation of HBV (negative HBV-DNA) 6-12 months after NUC interruption

    6 months after NUC interruption

Study Arms (1)

Single arm (vaccine)

EXPERIMENTAL

No further description

Biological: Hepatitis B vaccine

Interventions

Hepatitis B vaccineBIOLOGICAL

It may be GSk or MSD vaccine

Single arm (vaccine)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver Unit, Hospital Clinic

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Interventions

Hepatitis B Vaccines

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Central Study Contacts

xavier forns

CONTACT

34932275753xforns@clinic.cat

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 23, 2020

Study Start

September 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

July 31, 2020

Record last verified: 2020-06

Locations

ES(1)