Immune Response to Influenza Vaccine in ESRD Patients

Not Applicable

Completed

• Conditions: Nephrology; Immunology
• Interventions: Biological: Influenza vaccine

• Registration Number: NCT04122222
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2016-08-25
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Status Verified: 2019-10
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-08
• Last Update Submitted: 2019-10-08
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemodialysis	Influenza vaccine	ESRD patients treated by hemodialysis
Hemodiafiltration	Influenza vaccine	ESRD patients treated by on-line hemodiafiltration

Primary Outcome Measures

Name	Time	Method
measurement antibody titers, determined by hemagglutination inhibition (HI) assay.	12 months	measurement antibody titers, determined by hemagglutination inhibition (HI) assay.

Secondary Outcome Measures

Name	Time	Method
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.