The Effect and Safety of the Seasonal Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Not on Dialysis

The Immunogenicity and Safety of the Seasonal Influenza Vaccine, Formulation 2013-2014, in Chronic Kidney Disease Patients Not on Dialysis

In recent years, several studies revealed that the current influenza vaccine strategy might be of minimal vaccine effectiveness and had a smaller effect on reducing morbidity and mortality in the end-stage renal disease population than previously thought. Thus, this also raised the question about the effectiveness of administration of influenza vaccination in chronic kidney disease patients not on dialysis. In this study, the investigators aim to evaluate the effectiveness of seasonal trivalent influenza vaccine, formulation 2013-2014, in patients with different stage of chronic kidney disease (CKD) not on dialysis.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease; Immunogenicity and Adverse Drug Effect of Vaccines Influenza
• Intervention / Treatment: Biological: Seasonal influenza vaccine (AdimFlu-S)

Detailed Description

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by the method of hemagglutination inhibition (HI) and ELISA-based microneutralization (microNT-ELISA) assays. All participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 4). The investigators will collect serum of participants at the 5th weeks, 9th weeks, and 21th week post vaccination and evaluate the difference of immune response in these 3 groups.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yu-Tzu Chang, MD, MSc; Phone Number: 4930 886-2353535; Email: kangxiemperor@gmail.com

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng Kung University
    • Principal Investigator: Yu-Tzu Chang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. .Males and non-pregnant females and aged ≥ 18 years with chronic kidney disease not on dialysis;
2. .Willing and able to adhere to visit schedules and all study requirements;
3. .Subjects read and signed the study-specific informed consent.
4. .Subjects who has either received the first dose of 2013-2014 seasonal influenza vaccination before or not.

Exclusion Criteria:

1. .Subject or his/her family is employed by the participated hospital;
2. .History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
3. .Personal or family history of Guillain-Barré Syndrome;
4. .An acute febrile illness within 1 week prior to vaccination;
5. .Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
6. .Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
7. .Female subjects who are pregnant during the study.
8. .Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
9. .Immunodeficiency, or under immunosuppressive treatment.
10. .Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
11. .Receipt of any blood products, including immunoglobulin in the prior 3 months;
12. .Any severe illness needed to be hospitalization within three months.
13. .Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: The group receiving no influenza vaccine; Participants in this group will not receive any influenza vaccine (negative control group).
Experimental: One dose of AdimFlu-S group; Participants in this group will receive one dose of the seasonal trivalent influenza vaccine (one dose of AdimFlu-S group), formulation 2013-2014, at the initiation of the study. Each administered dose contain 15 ug virus antigen for each virus strain.	Biological: Seasonal influenza vaccine (AdimFlu-S); Participants receiving 0, 1 and 2 dose of AdimFlu-S during the study period.(a) No vaccination: no any influenza vaccination during the study period.(b) One dose of AdimFlu-S group: patient will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at the initiation of the study.(c)Two doses of AdimFlu-S group: patients will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at week 0 and 4 weeks after the initiation of the study.; Other Names: AdimFlu-S, manufactured by Adimmune company.
Experimental: Two dose of AdimFlu-S group; Participants in this group (Two dose of AdimFlu-S group)will receive the seasonal trivalent influenza vaccine, formulation 2013-2014, at the week 0 and 4 weeks after the initiation of the study. Each administered dose contain 15 ug virus antigen for each virus strain.	Biological: Seasonal influenza vaccine (AdimFlu-S); Participants receiving 0, 1 and 2 dose of AdimFlu-S during the study period.(a) No vaccination: no any influenza vaccination during the study period.(b) One dose of AdimFlu-S group: patient will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at the initiation of the study.(c)Two doses of AdimFlu-S group: patients will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at week 0 and 4 weeks after the initiation of the study.; Other Names: AdimFlu-S, manufactured by Adimmune company.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dynamic change of seroprotection rate related to administration of influenza virus vaccine strains (2013-2014 season) of the AdimFlu-S manufactured by Adimmune Corporation.	The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay might also be used to evaluate the seroprotection post vaccination, which will be defined as micro-NT titer ≥1: 40 or ≥ 1:160 .	The seroprotection rate will be assessed at 4, 8, 20 weeks after the initiation of the study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety of the influenza vaccination in patients with chronic kidney disease.	Patients who received influenza vaccination would be asked to record any local or systemic side effect during the first week after vaccination. Besides, the investigators would also monitor any possible adverse effect during the whole study period.	the safety issue related to the vaccination will be assessed in each visit during the whole study period (20 weeks).
The dynamic change of seroconversion rate related to administration of influenza virus vaccine strains (2013-2014 season) of the AdimFlu-S manufactured by Adimmune Corporation.	The seroconversion is defined as the HI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HI serum titer or a four-fold or greater increase in HI titers in subjects who had a positive pre-vaccination HAI serum titer. The seropositive is defined as the HI titer ≥ 1:10, and the seronegative is defined as HI titer < 1:10.	The seroconversion rate will be assessed at 4, 8, 20 weeks after the initiation of the study.
The dynamic change of seroresponse rate related to administration of influenza virus vaccine strains (2013-2014 season) of the AdimFlu-S manufactured by Adimmune Corporation.	The seroresponse is defined as HI or micro-NT titer of the post-vaccination serum is at least 4-fold increase of the HI or micro-NT titer after vaccination.	The seroresponse rate will be assessed at 4, 8, 20 weeks after the initiation of the study.

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Principal Investigator: An-Bang Wu, MD, National Cheng-Kung University Hospital; Principal Investigator: Ming-Cheng Wang, MD, National Cheng Kung University and Hospital; Principal Investigator: Chin-Chung Tseng, MD, PhD, National Cheng-Kung University Hospital; Principal Investigator: Junne-Ming Sung, MD, National Cheng Kung University and Hospital; Principal Investigator: Wei-Hung Lin, ＭＤ, National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 7, 2014

Study Record Updates

• Last Update Posted (Estimate): April 7, 2014
• Last Update Submitted That Met QC Criteria: April 4, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: trivalent influenza vaccine, chronic kidney disease
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Urologic Diseases; Renal Insufficiency; Orthomyxoviridae Infections; Kidney Diseases; Renal Insufficiency, Chronic; Influenza, Human; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: A-BR-101-139