Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-08-25
Study Completion Date
2018-07-20
Brief Summary
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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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Detailed Description
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Conditions
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Immunology
Nephrology
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
* 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.
* 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.
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Open label
Study Groups
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Hemodialysis
ESRD patients treated by hemodialysis
Group Type
ACTIVE_COMPARATOR
Influenza vaccine
Intervention Type
BIOLOGICAL
A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.
Hemodiafiltration
ESRD patients treated by on-line hemodiafiltration
Group Type
ACTIVE_COMPARATOR
Influenza vaccine
Intervention Type
BIOLOGICAL
A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.
Interventions
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Influenza vaccine
A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.
Intervention Type
BIOLOGICAL
Other Intervention Names
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A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.
Eligibility Criteria
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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
* 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
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Bhumirajanagarindra Kidney Institute, Thailand
OTHER
Sponsor Role
collaborator
Ministry of Health, Thailand
OTHER_GOV
Sponsor Role
collaborator
Mahidol University
OTHER
Sponsor Role
lead
Responsible Party
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Arkom Nongnuch
Assist. Prof
Responsibility Role
PRINCIPAL_INVESTIGATOR
References
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Reference Type
DERIVED
Other Identifiers
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07-59-14
Identifier Type: -
Identifier Source: org_study_id
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