Chronic Renal DiseaseIVVINCT02375711
Immunosenescence and Hepatitis B Virus (HBV) Vaccine Efficacy in Chronic Renal Disease Patient
A study testing Blood sample in people with Chronic Renal Disease, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Renal Disease
- What is being tested?
- Blood sample
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Sep 2017
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with an indication of HBV vaccination
- Patient with renal disease, with a creatinine clearance between 15 and 60ml/min
- Patient who have never been vaccinated against HBV
- Patient with negative serology for HBV
- Patient able to understand the reason of the study
- Patient not opposed to the conservation of biological samples for scientific research
Who cannot join
- Patient infected with Hepatitis B or with history of vaccination against HBV
- Patient suffering from psychotic illness
- Patient with any history of immunosuppressive therapy
- Patient with infectious and/or cancer diseases in evolution
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Immunosenescence as a Predictive Biomarker of HBV Vaccine Efficacy in Chronic Renal Disease Patient
The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency.
Read the detailed description
The risk of infection with hepatitis B during exposure to blood is high (30% against 1.8% for Hepatitis C Virus and HIV 1%) and dialysis patients are a population at risk. Vaccination against this virus, which is very effective in the general population (vaccine response: 90 to 95%), is highly recommended in dialysis patients. However, numerous studies have shown that HBV vaccination was less effective in patients with chronic renal disease than in the general population. The reasons for low vaccine response are poorly understood. However, recent data suggest that renal failure could induce accelerated immunosenescence.
The aging of the immune system, or immunosenescence, is a complex and profound phenomenon of the immune system during life. The gradual reduction of the generation of naive T cells in the thymus is the major cause of immunosenescence. But this process is also associated with an accumulation of lymphocytes at the end of differentiation.
In this context, the decrease in vaccine response and increased infections in renal insufficiency might be correlated, as in the elderly population, with the aging of the immune system. The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency.
Vaccination against HBV is not performed for the purposes of the study, but due to the existing vaccine indication for the subject. Included patients receive vaccination as routine care according to the recommendations and the vaccination schedule recommended by the Health Authority.
- Conditions
- Chronic Renal Disease
- Being tested
- Blood sample
- Keywords
- Chronic renal disease, Hepatitis B vaccine, Biological Aging
- Medical subject headings
- Renal Insufficiency, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
A blood sample of 35 ml is achieved at 1 month to evaluate the anti-HBV cell response. Two other blood samples of 10 ml are scheduled 3 and 6 months after vaccination to assess humoral response to HBV vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Renal Failure | Experimental | Patients with renal failure, with creatinine clearance between 60 and 15 ml/min. A blood sample is achieved at 0, 1, 3 and 6 months. Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cluster of Differentiation (CD) 8+ CD 57+ CD 28- / CD 8+ T lymphocytes Ratio in Peripheral Blood
The primary outcome is assessed 1 month after the vaccination schedule. The percentage of CD 8+ and CD 8+ CD 28- CD 57+ lymphocytes were determined by flow cytometry.
Measured: 13 months
Secondary outcomes (4)
Calculated Creatinine Clearance (Cockcroft-Gault Equation)
Creatinine clearance calculated using Cockcroft-Gault equation and adjusted for body surface area. Calculated Creatinine Clearance: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys.
Measured: 13 months
Interferon gamma and Interleukin-10 production of Peripheral blood T lymphocytes
Analysis of cytokine production is assessed by flow cytometry after stimulation of lymphocytes T.
Measured: 13 months
Percentage of Lymphocytes subpopulations in Peripheral Blood Mononuclear Cells
Different lymphocyte subpopulations will be quantified by flow cytometry using the following antibodies: CD 3, CD 4, CD 8, CD 19, CD 25, CD 27, CD 28, CD 31, CD 45RO, CD 45RA, CD 56, CD 62L, Cytotoxic T-Lymphocyte Antigen 4, Programmed cell death protein 1, CD 38, CD 127, Forkhead box P3.
Measured: 13 months
T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC)
TREC study used a technique of quantitative Polymerase Chain Reaction performed on DNA extracted from PBMC.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionSep 2016
- Study completionSep 2017
Why it stopped: Problems in including patients in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile COURIVAUD, Doctor, Principal investigator, University Hospital, Inserm UMR 1098, Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375711
- Sponsor's protocol ID
- P/2013/173
- Acronym
- IVVI
- Status last verified
- Jan 2018
- First submitted
- 9 Apr 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunosenescence as a Predictive Biomarker of HBV Vaccine Efficacy in Chronic Renal Disease Patient
- ClinicalTrials.gov ID
- NCT02375711
- Acronym / sponsor ID
- IVVI / P/2013/173
- Conditions
- Chronic Renal Disease
- Keywords
- Chronic renal disease, Hepatitis B vaccine, Biological Aging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problems in including patients in the study
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 3 Mar 2015 (estimated)
- 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.
The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency.
Detailed description
The risk of infection with hepatitis B during exposure to blood is high (30% against 1.8% for Hepatitis C Virus and HIV 1%) and dialysis patients are a population at risk. Vaccination against this virus, which is very effective in the general population (vaccine response: 90 to 95%), is highly recommended in dialysis patients. However, numerous studies have shown that HBV vaccination was less effective in patients with chronic renal disease than in the general population. The reasons for low vaccine response are poorly understood. However, recent data suggest that renal failure could induce accelerated immunosenescence.
The aging of the immune system, or immunosenescence, is a complex and profound phenomenon of the immune system during life. The gradual reduction of the generation of naive T cells in the thymus is the major cause of immunosenescence. But this process is also associated with an accumulation of lymphocytes at the end of differentiation.
In this context, the decrease in vaccine response and increased infections in renal insufficiency might be correlated, as in the elderly population, with the aging of the immune system. The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency.
Vaccination against HBV is not performed for the purposes of the study, but due to the existing vaccine indication for the subject. Included patients receive vaccination as routine care according to the recommendations and the vaccination schedule recommended by the Health Authority.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Renal Failure | Experimental | Biological: Blood samplePatients with renal failure, with creatinine clearance between 60 and 15 ml/min. A blood sample is achieved at 0, 1, 3 and 6 months. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with an indication of HBV vaccination
- Patient with renal disease, with a creatinine clearance between 15 and 60ml/min
- Patient who have never been vaccinated against HBV
- Patient with negative serology for HBV
- Patient able to understand the reason of the study
Key exclusion criteria (4 listed)
- Patient infected with Hepatitis B or with history of vaccination against HBV
- Patient suffering from psychotic illness
- Patient with any history of immunosuppressive therapy
- Patient with infectious and/or cancer diseases in evolution
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 |
|---|---|---|
| Blood sampleA blood sample of 35 ml is achieved at 1 month to evaluate the anti-HBV cell response. Two other blood samples of 10 ml are scheduled 3 and 6 months after vaccination to assess humoral response to HBV vaccination. | Biological | Chronic Renal Failure |
Primary outcome
Cluster of Differentiation (CD) 8+ CD 57+ CD 28- / CD 8+ T lymphocytes Ratio in Peripheral Blood
Time frame: 13 months
The primary outcome is assessed 1 month after the vaccination schedule. The percentage of CD 8+ and CD 8+ CD 28- CD 57+ lymphocytes were determined by flow cytometry.
4 secondary outcomes
Calculated Creatinine Clearance (Cockcroft-Gault Equation)
Time frame: 13 months
Interferon gamma and Interleukin-10 production of Peripheral blood T lymphocytes
Time frame: 13 months
Percentage of Lymphocytes subpopulations in Peripheral Blood Mononuclear Cells
Time frame: 13 months
T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC)
Time frame: 13 months
Results and safety
The study was stopped early (reason given: Problems in including patients in the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Cécile COURIVAUD, Doctor principal investigator
University Hospital, Inserm UMR 1098, Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Chronic Renal Disease, run by Centre Hospitalier Universitaire de Besancon 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Apr 2018. 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?
The study was stopped early (reason given: Problems in including patients in the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cluster of Differentiation (CD) 8+ CD 57+ CD 28- / CD 8+ T lymphocytes Ratio in Peripheral Blood (time frame: 13 months). 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 5 Apr 2018.