Skip to content

Immune Response to Influenza Vaccine in ESRD Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04122222
Enrollment
60
Registered
2019-10-10
Start date
2016-08-25
Completion date
2018-07-20
Last updated
2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunology, Nephrology

Keywords

ESRD, hemodialysis, hemodiafiltration, influenza vaccine, immune response

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.

Interventions

BIOLOGICALInfluenza vaccine

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

Sponsors

Bhumirajanagarindra Kidney Institute, Thailand
CollaboratorOTHER
Ministry of Health, Thailand
CollaboratorOTHER_GOV
Mahidol University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Open label

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
measurement antibody titers, determined by hemagglutination inhibition (HI) assay.12 monthsmeasurement antibody titers, determined by hemagglutination inhibition (HI) assay.

Secondary

MeasureTime frameDescription
measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses.12 monthsmeasurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026