ID

36687

Description

Immunosenescence and Hepatitis B Virus (HBV) Vaccine Efficacy in Chronic Renal Disease Patient; ODM derived from: https://clinicaltrials.gov/show/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. 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.

Link

https://clinicaltrials.gov/show/NCT02375711

Keywords

Versions (2)
  1. 1/15/19 1/15/19 -
  2. 6/1/19 6/1/19 -
Copyright Holder

Centre Hospitalier Universitaire de Besancon

Uploaded on

June 1, 2019

DOI

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License

Creative Commons BY-NC 3.0
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HBV Vaccine in Chronic Renal Disease NCT02375711

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Does the participant have an indication of hbv vaccination?
Description

The participant should have an indication of hbv vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0474232
Does the participant have renal disease, with a creatinine clearance between 15 and 60ml/min?
Description

The participant should have renal disease, with a creatinine clearance between 15 and 60ml/min

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0373595
Has the participant never been vaccinated against HBV?
Description

The participant should have not been vaccinated against HBV yet

Data type

boolean

Alias
UMLS CUI [1,1]
C4036128
UMLS CUI [1,2]
C0474232
Does the participant have a negative serology for HBV?
Description

The participant should have a negative serology for HBV

Data type

boolean

Alias
UMLS CUI [1,1]
C0744837
UMLS CUI [1,2]
C0205160
Is the participant able to understand the reason of the study?
Description

The participant should be able to understand the reason of the study

Data type

boolean

Alias
UMLS CUI [1,1]
C1273101
UMLS CUI [1,2]
C1285529
UMLS CUI [1,3]
C2603343
Is the participant not opposed to the conservation of biological samples for scientific research?
Description

The participant should not be opposed to the conservation of biological samples for scientific research

Data type

boolean

Alias
UMLS CUI [1,1]
C3641827
UMLS CUI [1,2]
C2347858
UMLS CUI [1,3]
C2347026
UMLS CUI [1,4]
C0035168
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Is the participant infected with Hepatitis B or has a history of vaccination against HBV?
Description

Hepatitis B status

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C0474232
UMLS CUI [2,2]
C0262926
Is the participant suffering from psychotic illness?
Description

Psychosis

Data type

boolean

Alias
UMLS CUI [1]
C0033975
Does the participant have a history of immunosuppressive therapy?
Description

Immosuppresive Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0262926
Does the participant have infectious and/or cancer diseases in evolution?
Description

Infection or Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C3714514
UMLS CUI [2]
C0006826
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
HBV Vaccination Indication
Item
Does the participant have an indication of hbv vaccination?
boolean
C3146298 (UMLS CUI [1,1])
C0474232 (UMLS CUI [1,2])
Renal disease
Item
Does the participant have renal disease, with a creatinine clearance between 15 and 60ml/min?
boolean
C0022658 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
No HBV Vaccination
Item
Has the participant never been vaccinated against HBV?
boolean
C4036128 (UMLS CUI [1,1])
C0474232 (UMLS CUI [1,2])
HBV Serology
Item
Does the participant have a negative serology for HBV?
boolean
C0744837 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
Ability to comprehend research purpose
Item
Is the participant able to understand the reason of the study?
boolean
C1273101 (UMLS CUI [1,1])
C1285529 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
Consent with biological samples
Item
Is the participant not opposed to the conservation of biological samples for scientific research?
boolean
C3641827 (UMLS CUI [1,1])
C2347858 (UMLS CUI [1,2])
C2347026 (UMLS CUI [1,3])
C0035168 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Hepatitis B status
Item
Is the participant infected with Hepatitis B or has a history of vaccination against HBV?
boolean
C3714514 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0474232 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Psychosis
Item
Is the participant suffering from psychotic illness?
boolean
C0033975 (UMLS CUI [1])
Immosuppresive Therapy
Item
Does the participant have a history of immunosuppressive therapy?
boolean
C0021079 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Infection or Neoplasms
Item
Does the participant have infectious and/or cancer diseases in evolution?
boolean
C3714514 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
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