Immune Response to Influenza Vaccine in ESRD Patients

NCT04122222 | Completed

• 1 other identifier: 07-59-14
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immunology; Nephrology

Keywords

ESRD; hemodialysis; hemodiafiltration; influenza vaccine; immune response

Outcome Measures

Primary Outcomes (1)

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

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

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

Hemodialysis

ACTIVE COMPARATOR

ESRD patients treated by hemodialysis

Biological: Influenza vaccine

Hemodiafiltration

ACTIVE COMPARATOR

ESRD patients treated by on-line hemodiafiltration

Biological: Influenza vaccine

Interventions

Influenza vaccine BIOLOGICAL

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

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

Hemodiafiltration; Hemodialysis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Bhumirajanagarindra Kidney Institute, Thailand: collaborator
• Ministry of Health, Thailand: collaborator

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MeSH Terms

Conditions

Kidney Failure, Chronic; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof

Model Details: * 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.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 10, 2019
• Study Start: August 25, 2016
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months