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

NCT02686398 | Completed Phase 4

• 1 other identifier: KUGH13170
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza; End Stage Renal Failure; Chronic Kidney Disease

Keywords

Influenza Vaccines; MF59 oil emulsion; End Stage Renal Failure on Dialysis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Seroprotection rate (A/H1N1, A/H3N2, B)

  6 months after vaccination

• Seroconversion rate (A/H1N1, A/H3N2, B)

  Change of titer from pre-vaccination to 6 months after vaccination

• GMT fold change (A/H1N1, A/H3N2, B)

  Change of GMT from pre-vaccination to 6 months after vaccination

Study Arms (2)

Fluad

ACTIVE COMPARATOR

88 CKD patients were vaccinated with Fluad.

Biological: Fluad

Agrippal

ACTIVE COMPARATOR

86 CKD patients were vaccinated with Agrippal.

Biological: Agrippal

Interventions

Fluad BIOLOGICAL

Fluad

Agrippal BIOLOGICAL

Agrippal

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

MeSH Terms

Conditions

Influenza, Human; Renal Insufficiency, Chronic

Interventions

fluad vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hee Jin Cheong, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 19, 2016
• Study Start: October 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 19, 2016

Record last verified: 2016-02