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

Phase 4

Completed

• Conditions: Influenza; Chronic Kidney Disease; End Stage Renal Failure
• Interventions: Biological: Fluad; Biological: Agrippal

• Registration Number: NCT02686398
• Lead Sponsor: Korea University Guro Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2016-01-25
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-15
• Last Update Submitted: 2016-02-15
• Study First Posted: 2016-02-19
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluad	Fluad	88 CKD patients were vaccinated with Fluad.
Agrippal	Agrippal	86 CKD patients were vaccinated with Agrippal.

Primary Outcome Measures

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

Secondary Outcome Measures

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