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

Study Overview
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Brief Summary
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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.

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

Conditions
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Influenza, End Stage Renal Failure, Chronic Kidney Disease

Intervention / Treatment
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* Biological: Fluad
* Biological: Agrippal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza Vaccines, MF59 oil emulsion, End Stage Renal Failure on Dialysis