Clinical trial NCT02375711: Immunosenescence and Hepatitis B Virus (HBV) Vaccine Efficacy in Chronic Renal Disease Patient
Official title: Evaluation of Immunosenescence as a Predictive Biomarker of HBV Vaccine Efficacy in Chronic Renal Disease Patient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Renal Disease
Keywords: Chronic renal disease
Hepatitis B vaccine
Biological Aging
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cluster of Differentiation (CD) 8+ CD 57+ CD 28- / CD 8+ T lymphocytes Ratio in Peripheral Blood
timeFrame: 13 months
Secondary outcomes:
measure: Calculated Creatinine Clearance (Cockcroft-Gault Equation)
timeFrame: 13 months
measure: Interferon gamma and Interleukin-10 production of Peripheral blood T lymphocytes
timeFrame: 13 months
measure: Percentage of Lymphocytes subpopulations in Peripheral Blood Mononuclear Cells
timeFrame: 13 months
measure: T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC)
timeFrame: 13 months
Other outcomes:
measure: Body Mass Index
timeFrame: at patient inclusion
measure: Cytomegalovirus (CMV) serology
timeFrame: 18 months
Locations:
city: Besançon
country: France
facility: Service de néphrologie, CHU de Besançon
Study officials:
affiliation: University Hospital, Inserm UMR 1098, Besançon
name: Cécile COURIVAUD, Doctor
role: PRINCIPAL_INVESTIGATOR
References: