Immunosenescence and Hepatitis B Virus (HBV) Vaccine Efficacy in Chronic Renal Disease Patient

Chronic Renal Disease Clinical Trial

— IVVI  

Official title:

Evaluation of Immunosenescence as a Predictive Biomarker of HBV Vaccine Efficacy in Chronic Renal Disease Patient

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02375711
• Other study ID #: P/2013/173
• Status: Terminated
• Phase: N/A
• First received: April 9, 2014
• Last updated: April 4, 2018
• Start date: March 2014
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
France	Service de néphrologie, CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index	body mass index= body weight (kg) divided by square of body height (m2)	at patient inclusion
Other	Cytomegalovirus (CMV) serology	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.	18 months
Primary	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.	13 months
Secondary	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.	13 months
Secondary	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.	13 months
Secondary	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.	13 months
Secondary	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.	13 months