Immunosenescence and Hepatitis B Virus (HBV) Vaccine Efficacy in Chronic Renal Disease Patient (IVVI)
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|ClinicalTrials.gov Identifier: NCT02375711|
Recruitment Status : Terminated (Problems in including patients in the study)
First Posted : March 3, 2015
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Renal Disease||Biological: Blood sample||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Immunosenescence as a Predictive Biomarker of HBV Vaccine Efficacy in Chronic Renal Disease Patient|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2017|
Experimental: Chronic Renal Failure
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.
Biological: Blood sample
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.
- 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.
- Calculated Creatinine Clearance (Cockcroft-Gault Equation) [ Time Frame: 13 months ]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.
- Interferon gamma and Interleukin-10 production of Peripheral blood T lymphocytes [ Time Frame: 13 months ]Analysis of cytokine production is assessed by flow cytometry after stimulation of lymphocytes T.
- Percentage of Lymphocytes subpopulations in Peripheral Blood Mononuclear Cells [ Time Frame: 13 months ]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.
- T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC) [ Time Frame: 13 months ]TREC study used a technique of quantitative Polymerase Chain Reaction performed on DNA extracted from PBMC.
- Body Mass Index [ Time Frame: at patient inclusion ]body mass index= body weight (kg) divided by square of body height (m2)
- Cytomegalovirus (CMV) serology [ Time Frame: 18 months ]Modeling of vaccine efficacy using a multivariate logistic regression will investigate whether there is a link between immunosenescence and vaccine response, adjusting on factors influencing the immunosenescence as CMV status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375711
|Service de néphrologie, CHU de Besançon|
|Besançon, France, 25000|
|Principal Investigator:||Cécile COURIVAUD, Doctor||University Hospital, Inserm UMR 1098, Besançon|