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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02105519
• Other study ID #: A-BR-101-139
• Status: Recruiting
• Phase: Phase 4
• First received: December 9, 2013
• Last updated: April 4, 2014
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2014
• Source: National Cheng-Kung University Hospital
• Contact: Yu-Tzu Chang, MD, MSc
• Phone: 886-2353535
• Email: kangxiemperor[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Drug-Related Side Effects and Adverse Reactions
• Immunogenicity and Adverse Drug Effect of Vaccines Influenza
• Influenza, Human
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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).	Yes
Secondary	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.	No
Secondary	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.	No