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Immunogenicity of a Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Undergoing Hemodialysis

Primary Purpose

Influenza, End Stage Renal Failure, Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fluad
Agrippal
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza Vaccines, MF59 oil emulsion, End Stage Renal Failure on Dialysis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic kidney disease patients undergoing hemodialysis
  • Who have given written informed consent at the time of enrollment

Exclusion Criteria:

  • Recipients of influenza vaccine of 2013-2014 season before the study
  • History of egg allergy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Fluad

    Agrippal

    Arm Description

    88 CKD patients were vaccinated with Fluad.

    86 CKD patients were vaccinated with Agrippal.

    Outcomes

    Primary Outcome Measures

    Seroprotection rate (A/H1N1, A/H3N2, B)
    the proportion of participants with a HI titer level of ≥1:40
    Seroconversion rate (A/H1N1, A/H3N2, B)
    the percentage of subjects with either a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in 1 month after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer <1:10 and a 1 month after vaccination HI titer of ≥1:40
    GMT fold change (A/H1N1, A/H3N2, B)
    GMT ratio of the 1 month after vaccination titer to pre-vaccination titer

    Secondary Outcome Measures

    Seroprotection rate (A/H1N1, A/H3N2, B)
    the proportion of participants with a HI titer level of ≥1:40
    Seroconversion rate (A/H1N1, A/H3N2, B)
    the percentage of subjects with either a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in 6 months after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer <1:10 and a 6 months after vaccination HI titer of ≥1:40
    GMT fold change (A/H1N1, A/H3N2, B)
    GMT ratio of the 6 months after vaccination titer to pre-vaccination titer

    Full Information

    First Posted
    January 25, 2016
    Last Updated
    February 15, 2016
    Sponsor
    Korea University Guro Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02686398
    Brief Title
    Immunogenicity of a Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Undergoing Hemodialysis
    Official Title
    Immunogenicity of a Trivalent Influenza Vaccine in Patients With Chronic Kidney Disease Undergoing Hemodialysis: MF59-adjuvanted Versus Non-adjuvanted Vaccines
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea University Guro Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study. The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted vaccine group) and were immunized with the respective vaccine. Sera were collected prior to vaccination and at 1and 6 months post vaccination. Levels of hemagglutination inhibition (HI) antibodies were measured.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza, End Stage Renal Failure, Chronic Kidney Disease
    Keywords
    Influenza Vaccines, MF59 oil emulsion, End Stage Renal Failure on Dialysis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    174 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluad
    Arm Type
    Active Comparator
    Arm Description
    88 CKD patients were vaccinated with Fluad.
    Arm Title
    Agrippal
    Arm Type
    Active Comparator
    Arm Description
    86 CKD patients were vaccinated with Agrippal.
    Intervention Type
    Biological
    Intervention Name(s)
    Fluad
    Intervention Type
    Biological
    Intervention Name(s)
    Agrippal
    Primary Outcome Measure Information:
    Title
    Seroprotection rate (A/H1N1, A/H3N2, B)
    Description
    the proportion of participants with a HI titer level of ≥1:40
    Time Frame
    1 month after vaccination
    Title
    Seroconversion rate (A/H1N1, A/H3N2, B)
    Description
    the percentage of subjects with either a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in 1 month after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer <1:10 and a 1 month after vaccination HI titer of ≥1:40
    Time Frame
    Change of titer from pre-vaccination to 1 month after vaccination
    Title
    GMT fold change (A/H1N1, A/H3N2, B)
    Description
    GMT ratio of the 1 month after vaccination titer to pre-vaccination titer
    Time Frame
    Change of GMT from pre-vaccination to 1 month after vaccination
    Secondary Outcome Measure Information:
    Title
    Seroprotection rate (A/H1N1, A/H3N2, B)
    Description
    the proportion of participants with a HI titer level of ≥1:40
    Time Frame
    6 months after vaccination
    Title
    Seroconversion rate (A/H1N1, A/H3N2, B)
    Description
    the percentage of subjects with either a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in 6 months after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer <1:10 and a 6 months after vaccination HI titer of ≥1:40
    Time Frame
    Change of titer from pre-vaccination to 6 months after vaccination
    Title
    GMT fold change (A/H1N1, A/H3N2, B)
    Description
    GMT ratio of the 6 months after vaccination titer to pre-vaccination titer
    Time Frame
    Change of GMT from pre-vaccination to 6 months after vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic kidney disease patients undergoing hemodialysis Who have given written informed consent at the time of enrollment Exclusion Criteria: Recipients of influenza vaccine of 2013-2014 season before the study History of egg allergy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hee Jin Cheong, MD, PhD
    Organizational Affiliation
    Korea University Guro Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Immunogenicity of a Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Undergoing Hemodialysis

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