HBVVITAMINNCT06307808
Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination
An observational study of HBV and Kidney Transplantation, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBV, Kidney Transplantation, Liver Transplantation
- What is being tested?
- Tacrolimus and Belatacept
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Kidney or liver transplant recipients
- Grenoble University Hospital regular follow-up
- Tacrolimus or belatacept treated
- Clinical indication for HBV booster vaccination
Who cannot join
- Pregnancy or lactating woman
- History of HBV infection (either anti-Hepatitis B capside antigen (HBc), positivity or HBV-DNA positivity)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HBV, Kidney Transplantation, Liver Transplantation
- Being tested
- Tacrolimus, Belatacept
- Keywords
- Hepatitis B virus, Kidney transplantation, Liver transplantation, Tacrolimus, Belatacept, HBV
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Calcineurin inhibitor
Immunosuppressive drug: main immunosuppressant is a calcineurin inhibitor (CNI), namely tacrolimus
BelataceptDrug
Also called Costimulation inhibitor, CTLA4-Ig
Immunosuppressive drug: main immunosuppressant is a costimulation inhibitor, namely belatacept
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients, tacrolimus treated | Prevalent kidney transplant recipients, receiving tacrolimus as main immunosuppresant Receives: Drug: Tacrolimus | |
| Liver transplant recipients, tacrolimus treated | Prevalent liver transplant recipients, receiving tacrolimus as main immunosuppressant Receives: Drug: Tacrolimus | |
| Kidney transplant recipients, belatacept treated | Prevalent kidney transplant recipients, receiving belatacept as main immunosuppressant Receives: Drug: Belatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titer of anti-HBs ELISA antibody
Anti-HBs HBV serological response
Measured: From enrollment to 6 months after inclusion
Secondary outcomes (1)
Number of anti-HBs memory B cells
B-ELISpot anti-HBs memory B cells
Measured: From enrollment to 6 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- National Agency for Research on AIDS and Viral Hepatitis (ANRS)
- Responsible party
- Sponsor
- Investigators
- Thomas JOUVE, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307808
- Sponsor's protocol ID
- Vitamin
- Acronym
- VITAMIN
- Status last verified
- Sep 2023
- First submitted
- 27 Nov 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients demographics and longitudinal HBV serological status
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Immunity in TrAnsplanted Patients Depending on iMmunosupressIon
- ClinicalTrials.gov ID
- NCT06307808
- Acronym / sponsor ID
- VITAMIN / Vitamin
- Conditions
- HBV, Kidney Transplantation, Liver Transplantation
- Keywords
- Hepatitis B virus, Kidney transplantation, Liver transplantation, Tacrolimus, Belatacept, HBV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- National Agency for Research on AIDS and Viral Hepatitis (ANRS)
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients, tacrolimus treated | – | Drug: TacrolimusPrevalent kidney transplant recipients, receiving tacrolimus as main immunosuppresant |
| Liver transplant recipients, tacrolimus treated | – | Drug: TacrolimusPrevalent liver transplant recipients, receiving tacrolimus as main immunosuppressant |
| Kidney transplant recipients, belatacept treated | – | Drug: BelataceptPrevalent kidney transplant recipients, receiving belatacept as main immunosuppressant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Kidney or liver transplant recipients
- Grenoble University Hospital regular follow-up
- Tacrolimus or belatacept treated
- Clinical indication for HBV booster vaccination
Key exclusion criteria (2 listed)
- Pregnancy or lactating woman
- History of HBV infection (either anti-Hepatitis B capside antigen (HBc), positivity or HBV-DNA positivity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusAlso: Calcineurin inhibitorImmunosuppressive drug: main immunosuppressant is a calcineurin inhibitor (CNI), namely tacrolimus | Drug | Kidney transplant recipients, tacrolimus treated, Liver transplant recipients, tacrolimus treated |
| BelataceptAlso: Costimulation inhibitor, CTLA4-IgImmunosuppressive drug: main immunosuppressant is a costimulation inhibitor, namely belatacept | Drug | Kidney transplant recipients, belatacept treated |
Primary outcome
Titer of anti-HBs ELISA antibody
Time frame: From enrollment to 6 months after inclusion
Anti-HBs HBV serological response
1 secondary outcome
Number of anti-HBs memory B cells
Time frame: From enrollment to 6 months post-enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Yes. Patients demographics and longitudinal HBV serological status
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas JOUVE, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV and Kidney Transplantation, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas JOUVE, MD, PhD (+33 4 76 76 54 60, tjouve@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titer of anti-HBs ELISA antibody (time frame: From enrollment to 6 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.