NCT06307808|UnknownDMC
Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination
VITAMIN
Viral Immunity in TrAnsplanted Patients Depending on iMmunosupressIon
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VITAMIN
Viral Immunity in TrAnsplanted Patients Depending on iMmunosupressIon
Sponsor study identifier
observational
66
1 country
1
Study Start
March 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 27, 2023
Actual (reported)March 13, 2024
Actual (reported)March 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Titer of anti-HBs ELISA antibody
Anti-HBs HBV serological response
From enrollment to 6 months after inclusion
Number of anti-HBs memory B cells
From enrollment to 6 months post-enrollment
Prevalent kidney transplant recipients, receiving tacrolimus as main immunosuppresant
Prevalent liver transplant recipients, receiving tacrolimus as main immunosuppressant
Prevalent kidney transplant recipients, receiving belatacept as main immunosuppressant
Immunosuppressive drug: main immunosuppressant is a calcineurin inhibitor (CNI), namely tacrolimus
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.
Grenoble University Hospital
Grenoble, AURA, 38043, France
Peripheral Blood Mononuclear Cells, plasma samples, whole blood samples.
Thomas JOUVE, MD, PhD
University Hospital, Grenoble
First Submitted
November 27, 2023
First Posted
March 13, 2024
Study Start
March 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2025
Estimated (date passed)TACrolimus in Renal Transplantation: Individualization by Pharmacogenetic
Immunosuppressive drug: main immunosuppressant is a costimulation inhibitor, namely belatacept
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 13, 2024
Record last verified: 2023-09
Patients demographics and longitudinal HBV serological status
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Source: ClinicalTrials.gov.
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