Immune Response to Influenza Vaccine in ESRD Patients

Immunology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04122222
• Other study ID #: 07-59-14
• Status: Completed
• Phase: N/A
• Start date: August 25, 2016
• Est. completion date: July 20, 2018

Study information

• Verified date: October 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Immunology
• Influenza, Human
• Nephrology

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Mahidol University	Bhumirajanagarindra Kidney Institute, Thailand, Ministry of Health, Thailand

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement antibody titers, determined by hemagglutination inhibition (HI) assay.	measurement antibody titers, determined by hemagglutination inhibition (HI) assay.	12 months
Secondary	measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses.	measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses.	12 months