NCT02375711

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Renal Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-09-01
• Completion: 2017-09-01
• First posted: 2015-03-03
• Last updated: 2018-04-05

Locations

1 site across 1 country: France