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

NCT06307808 | Unknown DMC

• 1 other identifier: Vitamin
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hepatitis B virus; Kidney transplantation; Liver transplantation; Tacrolimus; Belatacept; HBV

Outcome Measures

Primary Outcomes (1)

• Titer of anti-HBs ELISA antibody

  Anti-HBs HBV serological response

  From enrollment to 6 months after inclusion

Secondary Outcomes (1)

• Number of anti-HBs memory B cells

  From enrollment to 6 months post-enrollment

Study Arms (3)

Kidney transplant recipients, tacrolimus treated

Prevalent kidney transplant recipients, receiving tacrolimus as main immunosuppresant

Drug: Tacrolimus

Liver transplant recipients, tacrolimus treated

Prevalent liver transplant recipients, receiving tacrolimus as main immunosuppressant

Drug: Tacrolimus

Kidney transplant recipients, belatacept treated

Prevalent kidney transplant recipients, receiving belatacept as main immunosuppressant

Drug: Belatacept

Interventions

Tacrolimus DRUG

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

Also known as: Calcineurin inhibitor

Kidney transplant recipients, tacrolimus treated; Liver transplant recipients, tacrolimus treated

Belatacept DRUG

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

Also known as: Costimulation inhibitor, CTLA4-Ig

Kidney transplant recipients, belatacept treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• National Agency for Research on AIDS and Viral Hepatitis (ANRS): collaborator

Study Sites (1)

Grenoble University Hospital

Grenoble, AURA, 38043, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Mononuclear Cells, plasma samples, whole blood samples.

MeSH Terms

Conditions

Hepatitis B

Interventions

Tacrolimus; Calcineurin Inhibitors; Abatacept

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Thomas JOUVE, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas JOUVE, MD, PhD

CONTACT

+33 4 76 76 54 60; tjouve@chu-grenoble.fr

Mathilde BUGNAZET, BSc

CONTACT

+33 4 76 76 54 60; mbugnazet@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: March 13, 2024
• Study Start: March 15, 2024
• Primary Completion: September 30, 2025
• Study Completion: October 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: From study completion (expected 09/2025), for 5 years
• Access Criteria: Researchers wishing to investigate with our data set will contact the primary investigator and discuss the research project.

Locations

FR (1)