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Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients

Primary Purpose

Influenza

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
AdimFlu-S
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza focused on measuring Influenza vaccine, dialysis, vaccine, Seroprotection, Seroresponse, Seroconversion, Safety of the vaccine

Eligibility Criteria

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

Inclusion Criteria:

  1. Males and non-pregnant females and aged more than 18 years;
  2. Willing and able to adhere to visit schedules and all study requirements;
  3. Subjects read and signed the study-specific informed consent.

Exclusion Criteria:

  1. Subject or his/her family is employed by the participated hospital;
  2. Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
  3. History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
  4. Personal or family history of Guillain-Barré Syndrome;
  5. An acute febrile illness within 1 week prior to vaccination;
  6. Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
  7. 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;
  8. Female subjects who are pregnant during the study.
  9. Patients who receive hemodialysis therapy less than 3 months.
  10. Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
  11. Immunodeficiency, or under immunosuppressive treatment.
  12. 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);
  13. Receipt of any blood products, including immunoglobulin in the prior 3 months;
  14. Any severe illness needed to be hospitalization within three months.
  15. Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.

Sites / Locations

  • National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the immunogenicity profiles of the AdimFlu-S

The safety outcome of the vaccine

Arm Description

Experimental group: to receive either only one dose of influenza vaccine at day 0 or one more booster vaccination 3 weeks later. Negative control group: dialysis patients who refused to receive influenza vaccination.

Any adverse effect, including systemic or local site, will be recorded during the study period.

Outcomes

Primary Outcome Measures

Change of antibody titer before and after influenza vaccination
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay will also be used to evaluate the immune response post vaccination. The immune response based on microNT-ELISA antibody titers would be reported as antibody titer ≥1: 40 or ≥ 1:160 respectively because no threshold of protective NT antibody titer is clearly defined by the international guidelines.

Secondary Outcome Measures

Seroresponse rate
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.
Seroresponse rate
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. Geometric mean folds increase in HI or micro-NT titer.
the safety and tolerability profiles of the vaccine
evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation.

Full Information

First Posted
November 1, 2011
Last Updated
January 13, 2012
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01512056
Brief Title
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
Official Title
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012).
Detailed Description
The immune response to influenza vaccine was poor in dialysis population than general population. The investigators want to evaluate another booster vaccination can improve the immune response in dialysis population. All enrolled 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 3). The investigators will collect serum of participants 3 weeks, 6 weeks, 9 weeks and 18 weeks 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
Influenza
Keywords
Influenza vaccine, dialysis, vaccine, Seroprotection, Seroresponse, Seroconversion, Safety of the vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the immunogenicity profiles of the AdimFlu-S
Arm Type
Experimental
Arm Description
Experimental group: to receive either only one dose of influenza vaccine at day 0 or one more booster vaccination 3 weeks later. Negative control group: dialysis patients who refused to receive influenza vaccination.
Arm Title
The safety outcome of the vaccine
Arm Type
No Intervention
Arm Description
Any adverse effect, including systemic or local site, will be recorded during the study period.
Intervention Type
Drug
Intervention Name(s)
AdimFlu-S
Intervention Description
All enrolled 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 3). Each dose of vaccine contains 15μg antigen of each virus strain suggested by WHO (A/California/7/2009 (H1N1);A/Perth/16/2009 (H3N2);B/Brisbane/60/2008).
Primary Outcome Measure Information:
Title
Change of antibody titer before and after influenza vaccination
Description
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay will also be used to evaluate the immune response post vaccination. The immune response based on microNT-ELISA antibody titers would be reported as antibody titer ≥1: 40 or ≥ 1:160 respectively because no threshold of protective NT antibody titer is clearly defined by the international guidelines.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Seroresponse rate
Description
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.
Time Frame
0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
Title
Seroresponse rate
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. Geometric mean folds increase in HI or micro-NT titer.
Time Frame
0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
Title
the safety and tolerability profiles of the vaccine
Description
evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation.
Time Frame
0, 3 week, 6 weeks, 9 weeks, 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and non-pregnant females and aged more than 18 years; Willing and able to adhere to visit schedules and all study requirements; Subjects read and signed the study-specific informed consent. Exclusion Criteria: Subject or his/her family is employed by the participated hospital; Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months; 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. Patients who receive hemodialysis therapy less than 3 months. 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
Junne Ming Sung, MD
Phone
886-6-2353535
Ext
2594
Email
jmsung@mail.ncku.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Tzu Chang, MD and Msc
Phone
886-6-2353535
Ext
2593
Email
kangxiemperor@gmail.com
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junne Ming Sung, MD
Phone
886-6-2353535
Ext
2594
Email
jmsung@mail.ncku.edu.tw
First Name & Middle Initial & Last Name & Degree
Yu Tzu Chang, MD and Msc
Phone
886-6-2353535
Ext
2593
Email
kangxiemperor@gmail.com
First Name & Middle Initial & Last Name & Degree
Junne Ming Sung, MD
First Name & Middle Initial & Last Name & Degree
Yu Tzu Chang, MD and Msc
First Name & Middle Initial & Last Name & Degree
Yi Ching Yang, MD
First Name & Middle Initial & Last Name & Degree
Meng Te Lin, MD

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients

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