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

NCT ID: NCT02375711

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-09-30

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.

Conditions

Chronic Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Blood sample

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cécile COURIVAUD, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Inserm UMR 1098, Besançon

Locations

Service de néphrologie, CHU de Besançon

Besançon, , France

Countries

France

Other Identifiers

P/2013/173

Identifier Type: -

Identifier Source: org_study_id