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

Primary Purpose

Immunogenicity and Adverse Drug Effect of Vaccines Influenza, Chronic Kidney Disease

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Seasonal influenza vaccine (AdimFlu-S)

About this trial

This is an interventional treatment trial for Immunogenicity and Adverse Drug Effect of Vaccines Influenza focused on measuring trivalent influenza vaccine, chronic kidney disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

.Subject or his/her family is employed by the participated hospital;
.History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
.Personal or family history of Guillain-Barré Syndrome;
.An acute febrile illness within 1 week prior to vaccination;
.Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
.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;
.Female subjects who are pregnant during the study.
.Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
.Immunodeficiency, or under immunosuppressive treatment.
.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);
.Receipt of any blood products, including immunoglobulin in the prior 3 months;
.Any severe illness needed to be hospitalization within three months.
.Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.

Sites / Locations

National Cheng Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

The group receiving no influenza vaccine

One dose of AdimFlu-S group

Two dose of AdimFlu-S group

Arm Description

Participants in this group will not receive any influenza vaccine (negative control 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.

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.

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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 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 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.

Full Information

NCT ID

NCT02105519

First Posted

December 9, 2013

Last Updated

April 4, 2014

Sponsor

National Cheng-Kung University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02105519

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cheng-Kung University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immunogenicity and Adverse Drug Effect of Vaccines Influenza, Chronic Kidney Disease

Keywords

trivalent influenza vaccine, chronic kidney disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

The group receiving no influenza vaccine

Arm Type

No Intervention

Arm Description

Participants in this group will not receive any influenza vaccine (negative control group).

Arm Title

One dose of AdimFlu-S group

Arm Type

Experimental

Arm Description

Arm Title

Two dose of AdimFlu-S group

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Seasonal influenza vaccine (AdimFlu-S)

Other Intervention Name(s)

AdimFlu-S, manufactured by Adimmune company.

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

The seroprotection rate will be assessed at 4, 8, 20 weeks after the initiation of the study.

Secondary Outcome Measure Information:

Title

The safety of the influenza vaccination in patients with chronic kidney disease.

Description

Time Frame

the safety issue related to the vaccination will be assessed in each visit during the whole study period (20 weeks).

Title

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.

Description

Time Frame

The seroconversion rate will be assessed at 4, 8, 20 weeks after the initiation of the study.

Title

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.

Description

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.

Time Frame

The seroresponse rate will be assessed at 4, 8, 20 weeks after the initiation of the study.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: .Males and non-pregnant females and aged ≥ 18 years with chronic kidney disease not on dialysis; .Willing and able to adhere to visit schedules and all study requirements; .Subjects read and signed the study-specific informed consent. .Subjects who has either received the first dose of 2013-2014 seasonal influenza vaccination before or not. Exclusion Criteria: .Subject or his/her family is employed by the participated hospital; .History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication; .Personal or family history of Guillain-Barré Syndrome; .An acute febrile illness within 1 week prior to vaccination; .Current upper respiratory illness, including the common cold or nasal congestion within 72 hours; .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; .Female subjects who are pregnant during the study. .Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent; .Immunodeficiency, or under immunosuppressive treatment. .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); .Receipt of any blood products, including immunoglobulin in the prior 3 months; .Any severe illness needed to be hospitalization within three months. .Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yu-Tzu Chang, MD, MSc

Phone

886-2353535

Ext

4930

kangxiemperor@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming-Cheng Wang, MD

Organizational Affiliation

National Cheng Kung University and Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chin-Chung Tseng, MD, PhD

Organizational Affiliation

National Cheng-Kung University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Junne-Ming Sung, MD

Organizational Affiliation

National Cheng Kung University and Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

An-Bang Wu, MD

Organizational Affiliation

National Cheng-Kung University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wei-Hung Lin, ＭＤ

Organizational Affiliation

National Cheng-Kung University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cheng Kung University

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu-Tzu Chang, MD

12. IPD Sharing Statement

Learn more about this trial

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

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