Immune Response to Influenza Vaccine in ESRD Patients

Study Overview
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Brief Summary
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On-line hemodiafiltration (HDF) clears more azotaemic toxins compared to high-flux hemodialysis (HD). The response to vaccination is impaired in dialysis patients. We aimed to study the immune responses to influenza vaccine in dialysis patients treated by HDF vs. HD.

Official Title
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Immune Response to Influenza Vaccination in ESRD Patients Undergoing Hemodialysis vs. Hemodiafiltration

Conditions
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Immunology, Nephrology

Intervention / Treatment
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* Biological: Influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - ESRD patients aged 18 years or older, who had been treated for more than one month of either thrice weekly on-line hemodiafiltration (HDF) or conventional high flux hemodialysis (HD), with a session dialyzer urea clearance (Kt/V urea) of 1.2 and greater, with a convection volume target of 20 L/session for the HDF group Exclusion Criteria: Had received any vaccination within the previous four weeks, or influenza vaccination within six months Patient who reported upper respiratory tract symptoms within three days prior to the study vaccination A history of allergy to influenza vaccine or egg Thrombocytopenia In receipt of immunosuppressant medications, chemotherapy, or had immunodeficiency
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective cohort study in chronic dialysis patients during the 2016 and 2017 influenza seasons All participants received a single standard dose of trivalent influenza vaccine The elicited humoral immune response by hemagglutination inhibition test, and cell-mediated immune response by enumeration of lymphocyte cellular markers and proliferation assays are studied.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hemodialysis<br>ESRD patients treated by hemodialysis | Biological: Influenza vaccine<br>* A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.<br>* Other names: A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.;|
| Active Comparator: Hemodiafiltration<br>ESRD patients treated by on-line hemodiafiltration | Biological: Influenza vaccine<br>* A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.<br>* Other names: A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement antibody titers, determined by hemagglutination inhibition (HI) assay. | measurement antibody titers, determined by hemagglutination inhibition (HI) assay. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses. | measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, hemodialysis, hemodiafiltration, influenza vaccine, immune response