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

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ClinicalTrials.gov Identifier: NCT02105519
Recruitment Status : Unknown
Verified April 2014 by Yu-Tzu Chang, National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
Yu-Tzu Chang, National Cheng-Kung University Hospital

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.

Condition or disease Intervention/treatment Phase
Immunogenicity and Adverse Drug Effect of Vaccines Influenza Chronic Kidney Disease Biological: Seasonal influenza vaccine (AdimFlu-S) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Immunogenicity and Safety of the Seasonal Influenza Vaccine, Formulation 2013-2014, in Chronic Kidney Disease Patients Not on Dialysis
Study Start Date : October 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: AdimFlu-S, manufactured by Adimmune company.




Primary Outcome Measures :
  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. [ Time Frame: The seroprotection rate will be assessed at 4, 8, 20 weeks after the initiation of the study. ]
    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 :
  1. The safety of the influenza vaccination in patients with chronic kidney disease. [ Time Frame: the safety issue related to the vaccination will be assessed in each visit during the whole study period (20 weeks). ]
    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.

  2. 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. [ Time Frame: The seroconversion rate will be assessed at 4, 8, 20 weeks after the initiation of the study. ]
    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.

  3. 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. [ Time Frame: The seroresponse rate will be assessed at 4, 8, 20 weeks after the initiation of the study. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105519


Contacts
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Contact: Yu-Tzu Chang, MD, MSc 886-2353535 ext 4930 kangxiemperor@gmail.com

Locations
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Taiwan
National Cheng Kung University Recruiting
Tainan, Taiwan, 704
Principal Investigator: Yu-Tzu Chang, MD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
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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: An-Bang Wu, MD National Cheng-Kung University Hospital
Principal Investigator: Wei-Hung Lin, MD National Cheng-Kung University Hospital

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Responsible Party: Yu-Tzu Chang, Attending physician, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02105519     History of Changes
Other Study ID Numbers: A-BR-101-139
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014
Keywords provided by Yu-Tzu Chang, National Cheng-Kung University Hospital:
trivalent influenza vaccine, chronic kidney disease
Additional relevant MeSH terms:
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Influenza, Human
Kidney Diseases
Renal Insufficiency, Chronic
Drug-Related Side Effects and Adverse Reactions
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Urologic Diseases
Renal Insufficiency
Chemically-Induced Disorders
Vaccines
Immunologic Factors
Physiological Effects of Drugs