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Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination

NCT06307808 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2024-03-13

No results posted yet for this study

Summary

Solid Organ Transplantation (SOT) is made possible by the use of a lifelong immunosuppressive treatment. This treatment limits the response of the immune system, enabling long-term survival of the transplanted organ, but also leading to weaker anti-infectious responses.

In this study, we will compare the response to a booster Hepatitis B vaccination (HBV) in SOT patients, either after kidney or liver transplantation. We will also compare the immune response depending on the immunosuppressive treatment.

In order to provide a detailed picture of the immune response, we will investigate the usual serological response (anti-HBs antibodies), but also the cellular memory (both T and B) using ELISpot assays and flow-cytometry, over a 6 months period following booster vaccination.

Conditions

  • HBV
  • Kidney Transplantation
  • Liver Transplantation

Interventions

DRUG

Tacrolimus

Immunosuppressive drug: main immunosuppressant is a calcineurin inhibitor (CNI), namely tacrolimus

DRUG

Belatacept

Immunosuppressive drug: main immunosuppressant is a costimulation inhibitor, namely belatacept

Sponsors & Collaborators

  • National Agency for Research on AIDS and Viral Hepatitis (ANRS)

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Thomas JOUVE, MD, PhD · University Hospital, Grenoble

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2025-09-30
Completion
2025-10-01

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT06307808 on ClinicalTrials.gov