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

NCT02105519 | Unknown Phase 4

• 1 other identifier: A-BR-101-139
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

trivalent influenza vaccine, chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

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

Study Arms (3)

The group receiving no influenza vaccine

NO INTERVENTION

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

One dose of AdimFlu-S group

EXPERIMENTAL

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)

Two dose of AdimFlu-S group

EXPERIMENTAL

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)

Interventions

Seasonal influenza vaccine (AdimFlu-S) BIOLOGICAL

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.

Also known as: AdimFlu-S, manufactured by Adimmune company.

One dose of AdimFlu-S group; Two dose of AdimFlu-S group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University

Tainan, Taiwan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Influenza, Human

Condition Hierarchy (Ancestors)

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; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• 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

• An-Bang Wu, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

• Wei-Hung Lin, ＭＤ

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Tzu Chang, MD, MSc

CONTACT

886-2353535; kangxiemperor@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: April 7, 2014
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 7, 2014

Record last verified: 2014-04

Locations

TW (1)