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

March 11, 2024 updated by: University Hospital, Grenoble

Viral Immunity in TrAnsplanted Patients Depending on iMmunosupressIon

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Solid Organ Transplantation (SOT) is the reference treatment for end stage kidney disease (Kidney Transplantation, KT) and liver failure (Liver Transplantation, LT). As of 2023, an immunosuppressive treatment remains mandatory for long-term graft survival. This treatment translates into a weaker response to vaccines. The recent example of Severe Acute Respiratory Syndrom (SARS) - Coronavirus (CoV), SARS-CoV-2, showed different vaccinal responses depending on the immunosuppressive drug, comparing belatacept- to tacrolimus-based immunosuppression.

Hepatitis B virus (HBV)-vaccination is recommended in chronic kidney failure and liver failure. However, post-transplantation, a loss of HBV seroprotection is seen in ~ 30 % of the patients. A booster HBV vaccine dose is recommended in such case, but the evaluation of the response to this booster dose is limited.

In the Viral Immunity in TrAnsplanted patients depending on iMmunosupressIoN (VITAMIN) study, investigators will investigate the effect of a HBV-vaccine booster on the immune system, comparing KT recipients treated with Belatacept with KT and LT recipients treated with Tacrolimus. The VITAMIN study is a prospective observational study recruiting KT and LT recipients from the time of a booster HBV vaccine injection and over the following 6 months. The idea is to take advantage of this very particular sensitizing event, at a defined timepoint, to investigate the immune response to HBV through vaccination. Investigators will focus on comparing the immunological state before and after vaccination, in kidney and liver transplant recipients receiving immunosuppression.

The immunological state will be described through 1/ the antibody response, 2/ its phenotype (both exploring the T cell compartment and the B cell compartment, including memory B cells, using flow cytometry) and 3/ its functional response (through the ELISpot assessment of the T response against HBV HBs antigen). Sequential blood samples will be taken, using Peripheral Blood Monocytic Cells (PBMC). Also, investigators will focus on HBV-specific memory B cells, to detect potential antibody secreting cells. This project will provide a longitudinal picture of all immune compartments stimulated by HBV vaccination. This longitudinal picture will be compared between tacrolimus-treated KT and LT recipients and belatacept-treated KT recipients.

The main objective is to compare the serological response (anti-HBs antibodies) between tacrolimus- and belatacept-treated patients. The secondary objective is to describe and compare the phenotype and functional T and B responses between tacrolimus- and belatacept-treated patients.

Comparing different immunosuppressive regimen through the immunological responses, investigators aim at improving the personalization of the immunosuppressive treatment.

Study Type

Observational

Enrollment (Estimated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Aura
      • Grenoble, Aura, France, 38043
        • Grenoble University Hospital
        • Principal Investigator:
          • Pr Thomas Jouve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients having received a kidney or liver transplant, with a regular follow-up at Grenoble University Hospital. Patients should have received a previous HBV vaccination. Anti-HBs antibody titer should have decreased to < 10 mUI/ml or have decreased > 50 mUI/ml when compared to a pre-transplantion status.

Patients should receive a tacrolimus or belatacept-based immunosuppression.

Description

Inclusion Criteria:

  • Kidney or liver transplant recipients
  • Grenoble University Hospital regular follow-up
  • Tacrolimus or belatacept treated
  • Clinical indication for HBV booster vaccination

Exclusion Criteria:

  • Pregnancy or lactating woman
  • History of HBV infection (either anti-Hepatitis B capside antigen (HBc), positivity or HBV-DNA positivity)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Kidney transplant recipients, tacrolimus treated
Prevalent kidney transplant recipients, receiving tacrolimus as main immunosuppresant
Drug: Tacrolimus
Immunosuppressive drug: main immunosuppressant is a calcineurin inhibitor (CNI), namely tacrolimus
Other Names:
  • Calcineurin inhibitor
Liver transplant recipients, tacrolimus treated
Prevalent liver transplant recipients, receiving tacrolimus as main immunosuppressant
Drug: Tacrolimus
Immunosuppressive drug: main immunosuppressant is a calcineurin inhibitor (CNI), namely tacrolimus
Other Names:
  • Calcineurin inhibitor
Kidney transplant recipients, belatacept treated
Prevalent kidney transplant recipients, receiving belatacept as main immunosuppressant
Drug: Belatacept
Immunosuppressive drug: main immunosuppressant is a costimulation inhibitor, namely belatacept
Other Names:
  • CTLA4-Ig
  • Costimulation inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Titer of anti-HBs ELISA antibody
Time Frame: From enrollment to 6 months after inclusion
Anti-HBs HBV serological response
From enrollment to 6 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of anti-HBs memory B cells
Time Frame: From enrollment to 6 months post-enrollment
B-ELISpot anti-HBs memory B cells
From enrollment to 6 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

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

Investigators

  • Principal Investigator: Thomas JOUVE, MD, PhD, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patients demographics and longitudinal HBV serological status

IPD Sharing Time Frame

From study completion (expected 09/2025), for 5 years

IPD Sharing Access Criteria

Researchers wishing to investigate with our data set will contact the primary investigator and discuss the research project.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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