NCT02375711

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 5, 2018

Status Verified

January 1, 2018

Enrollment Period

2.5 years

First QC Date

April 9, 2014

Last Update Submit

April 4, 2018

Conditions

Chronic Renal Disease

Keywords

Chronic renal diseaseHepatitis B vaccineBiological Aging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Calculated Creatinine Clearance (Cockcroft-Gault Equation)

    13 months

  • Interferon gamma and Interleukin-10 production of Peripheral blood T lymphocytes

    13 months

  • Percentage of Lymphocytes subpopulations in Peripheral Blood Mononuclear Cells

    13 months

  • T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC)

    13 months

Other Outcomes (2)

  • Body Mass Index

    at patient inclusion

  • Cytomegalovirus (CMV) serology

    18 months

Study Arms (1)

Chronic Renal Failure

EXPERIMENTAL

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

Interventions

Blood sampleBIOLOGICAL

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.

Chronic Renal Failure

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de néphrologie, CHU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicHepatitis B

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Cécile COURIVAUD, Doctor

    University Hospital, Inserm UMR 1098, Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2014

First Posted

March 3, 2015

Study Start

March 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

April 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)