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

This study is currently recruiting participants.
Verified January 2012 by National Cheng-Kung University Hospital
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01512056
First received: November 1, 2011
Last updated: January 13, 2012
Last verified: January 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Influenza
 Drug: AdimFlu-S
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Flu
U.S. FDA Resources

Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • Change of antibody titer before and after influenza vaccination [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0, 3 week, 6 weeks, 9 weeks, 18 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: the immunogenicity profiles of the AdimFlu-S

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.

 Drug: AdimFlu-S
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).
No Intervention: The safety outcome of the vaccine
Any adverse effect, including systemic or local site, will be recorded during the study period.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512056

Contacts
Contact: Junne Ming Sung, MD 886-6-2353535 ext 2594 jmsung@mail.ncku.edu.tw
Contact: Yu Tzu Chang, MD and Msc 886-6-2353535 ext 2593 kangxiemperor@gmail.com

Locations
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Junne Ming Sung, MD     886-6-2353535 ext 2594     jmsung@mail.ncku.edu.tw    
Contact: Yu Tzu Chang, MD and Msc     886-6-2353535 ext 2593     kangxiemperor@gmail.com    
Principal Investigator: Junne Ming Sung, MD            
Sub-Investigator: Yu Tzu Chang, MD and Msc            
Sub-Investigator: Yi Ching Yang, MD            
Sub-Investigator: Meng Te Lin, MD            
Sponsors and Collaborators
National Cheng-Kung University Hospital
  More Information

No publications provided

Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01512056     History of Changes
Other Study ID Numbers: BR-100-086
Study First Received: November 1, 2011
Last Updated: January 13, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Cheng-Kung University Hospital:
Influenza vaccine
dialysis
vaccine
Seroprotection
 Seroresponse
Seroconversion
Safety of the vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013