We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02375711
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment
Chronic Renal Disease Biological: Blood sample

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Immunosenescence as a Predictive Biomarker of HBV Vaccine Efficacy in Chronic Renal Disease Patient
Study Start Date : March 2014
Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other Outcome Measures:
  1. Body Mass Index [ Time Frame: at patient inclusion ]
    body mass index= body weight (kg) divided by square of body height (m2)

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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

Contact: Cécile COURIVAUD, Doctor +33381218585 ccourivaud@chu-besancon.fr
Contact: Ingrid TISSOT +33381218427 itissot@chu-besancon.fr

Service de néphrologie, CHU de Besançon Recruiting
Besançon, France, 25000
Contact: Cécile COURIVAUD, Doctor       ccourivaud@chu-besancon.fr   
Contact: Ingrid TISSOT       itissot@chu-besancon.fr   
Principal Investigator: COURIVAUD Cécile, Doctor         
Sub-Investigator: Didier DUCLOUX, Prof         
Sub-Investigator: Jamal BAMOULID, Doctor         
Sub-Investigator: Thomas CREPIN, Doctor         
Sub-Investigator: Jean-Marc CHALOPIN, Prof         
Sub-Investigator: Catherine BRESSON-VAUTRIN, Doctor         
Sub-Investigator: Caroline ROUBIOU, Doctor         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Principal Investigator: Cécile COURIVAUD, Doctor University Hospital, Inserm UMR 1098, Besançon

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02375711     History of Changes
Other Study ID Numbers: P/2013/173
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Chronic renal disease
Hepatitis B vaccine
Biological Aging

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Immunologic Factors
Physiological Effects of Drugs