Immune Response to Influenza Vaccine in ESRD Patients

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.

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Key information

Conditions

Immunology Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Influenza, Human Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Nephrology Orthomyxoviridae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Urologic Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

influenza vaccine

Biological

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.

Primary outcomes

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

Time frame: 12 months

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

Secondary outcomes

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

Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

Bhumirajanagarindra Kidney Institute, Thailand
Ministry of Health, Thailand

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Oct 10, 2019
Registry last updated: Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed