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

Not yet recruiting

• Conditions: HBV; Liver Transplantation; Kidney Transplantation
• Interventions: Drug: Tacrolimus; Drug: Belatacept

• Registration Number: NCT06307808
• Lead Sponsor: University Hospital, Grenoble

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.
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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 Respir...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13
• Study Start: 2024-03-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney transplant recipients, tacrolimus treated	Tacrolimus	Prevalent kidney transplant recipients, receiving tacrolimus as main immunosuppresant
Liver transplant recipients, tacrolimus treated	Tacrolimus	Prevalent liver transplant recipients, receiving tacrolimus as main immunosuppressant
Kidney transplant recipients, belatacept treated	Belatacept	Prevalent kidney transplant recipients, receiving belatacept as main immunosuppressant

Primary Outcome Measures

Name	Time	Method
Titer of anti-HBs ELISA antibody	From enrollment to 6 months after inclusion	Anti-HBs HBV serological response

Secondary Outcome Measures

Name	Time	Method
Number of anti-HBs memory B cells	From enrollment to 6 months post-enrollment	B-ELISpot anti-HBs memory B cells

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 Grenoble, Aura, France