HBV Vaccine in Anti-core Positive Donors After LT (NCT04442841) | Clinical Trial Compass
UnknownPhase 2
HBV Vaccine in Anti-core Positive Donors After LT
Spain114 participantsStarted 2020-09
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* • 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Response to HBV vaccine
Timeframe: 1 month after last HBV vaccine dose
2
Incidence of Emergent Adverse Events in case of nucleos(t)ide analogue (NUC) treatment interruption