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Immune Response to Influenza Vaccine in ESRD Patients

Primary Purpose

Immunology, Nephrology

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Influenza vaccine

About this trial

This is an interventional prevention trial for Immunology focused on measuring ESRD, hemodialysis, hemodiafiltration, influenza vaccine, immune response

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Hemodialysis

Hemodiafiltration

Arm Description

ESRD patients treated by hemodialysis

ESRD patients treated by on-line hemodiafiltration

Outcomes

Primary Outcome Measures

measurement antibody titers, determined by hemagglutination inhibition (HI) assay.

Secondary Outcome Measures

measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses.

Full Information

NCT ID

NCT04122222

First Posted

October 3, 2019

Last Updated

October 8, 2019

Sponsor

Mahidol University

Collaborators

Bhumirajanagarindra Kidney Institute, Thailand, Ministry of Health, Thailand

1. Study Identification

Unique Protocol Identification Number

NCT04122222

Brief Title

Immune Response to Influenza Vaccine in ESRD Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

August 25, 2016 (Actual)

Primary Completion Date

July 20, 2018 (Actual)

Study Completion Date

July 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

Collaborators

Bhumirajanagarindra Kidney Institute, Thailand, Ministry of Health, Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immunology, Nephrology

Keywords

ESRD, hemodialysis, hemodiafiltration, influenza vaccine, immune response

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Masking Description

Open label

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hemodialysis

Arm Type

Active Comparator

Arm Description

ESRD patients treated by hemodialysis

Arm Title

Hemodiafiltration

Arm Type

Active Comparator

Arm Description

ESRD patients treated by on-line hemodiafiltration

Intervention Type

Biological

Intervention Name(s)

Influenza vaccine

Other Intervention Name(s)

A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.

Intervention Description

A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.

Primary Outcome Measure Information:

Title

measurement antibody titers, determined by hemagglutination inhibition (HI) assay.

Description

measurement antibody titers, determined by hemagglutination inhibition (HI) assay.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses.

Description

measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses.

Time Frame

12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

International journal involving immunology and/or nephrology

IPD Sharing Time Frame

6 months

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Immune Response to Influenza Vaccine in ESRD Patients

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