Immune Response to Influenza Vaccine in ESRD Patients

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT04122222

Collaborator

Bhumirajanagarindra Kidney Institute, Thailand (Other), Ministry of Health, Thailand (Other)

Enrollment

Arms

22.8

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Immunology Nephrology	Biological: Influenza vaccine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 25, 2016

Actual Primary Completion Date :

Jul 20, 2018

Actual Study Completion Date :

Jul 20, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Hemodialysis

ESRD patients treated by hemodialysis

Biological: Influenza vaccine

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

Other Names:

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

Active Comparator: Hemodiafiltration

ESRD patients treated by on-line hemodiafiltration

Biological: Influenza vaccine

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

Other Names:

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

Outcome Measures

Primary Outcome Measures

measurement antibody titers, determined by hemagglutination inhibition (HI) assay. [12 months]
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. [12 months]
measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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