Clinical trial NCT02105519: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Immunogenicity and Adverse Drug Effect of Vaccines Influenza
Chronic Kidney Disease
Keywords: trivalent influenza vaccine, chronic kidney disease
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: The seroprotection rate will be assessed at 4, 8, 20 weeks after the initiation of the study.
Secondary outcomes:
measure: The safety of the influenza vaccination in patients with chronic kidney disease.
timeFrame: the safety issue related to the vaccination will be assessed in each visit during the whole study period (20 weeks).
measure: 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.
timeFrame: The seroconversion rate will be assessed at 4, 8, 20 weeks after the initiation of the study.
measure: 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.
timeFrame: The seroresponse rate will be assessed at 4, 8, 20 weeks after the initiation of the study.
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University and Hospital
name: Ming-Cheng Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cheng-Kung University Hospital
name: Chin-Chung Tseng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cheng Kung University and Hospital
name: Junne-Ming Sung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cheng-Kung University Hospital
name: An-Bang Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cheng-Kung University Hospital
name: Wei-Hung Lin, ＭＤ
role: PRINCIPAL_INVESTIGATOR
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