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

February 15, 2016 updated by: Hee Jin Cheong, Korea University Guro Hospital

Immunogenicity of a Trivalent Influenza Vaccine in Patients With Chronic Kidney Disease Undergoing Hemodialysis: MF59-adjuvanted Versus Non-adjuvanted Vaccines

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fluad
88 CKD patients were vaccinated with Fluad.
Biological: Fluad
Active Comparator: Agrippal
86 CKD patients were vaccinated with Agrippal.
Biological: Agrippal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprotection rate (A/H1N1, A/H3N2, B)
Time Frame: 1 month after vaccination
the proportion of participants with a HI titer level of ≥1:40
1 month after vaccination
Seroconversion rate (A/H1N1, A/H3N2, B)
Time Frame: Change of titer from pre-vaccination to 1 month after vaccination
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
Change of titer from pre-vaccination to 1 month after vaccination
GMT fold change (A/H1N1, A/H3N2, B)
Time Frame: Change of GMT from pre-vaccination to 1 month after vaccination
GMT ratio of the 1 month after vaccination titer to pre-vaccination titer
Change of GMT from pre-vaccination to 1 month after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprotection rate (A/H1N1, A/H3N2, B)
Time Frame: 6 months after vaccination
the proportion of participants with a HI titer level of ≥1:40
6 months after vaccination
Seroconversion rate (A/H1N1, A/H3N2, B)
Time Frame: Change of titer from pre-vaccination to 6 months after vaccination
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
Change of titer from pre-vaccination to 6 months after vaccination
GMT fold change (A/H1N1, A/H3N2, B)
Time Frame: Change of GMT from pre-vaccination to 6 months after vaccination
GMT ratio of the 6 months after vaccination titer to pre-vaccination titer
Change of GMT from pre-vaccination to 6 months after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Investigators

  • Principal Investigator: Hee Jin Cheong, MD, PhD, Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

February 15, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 15, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUGH13170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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