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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01512056
• Other study ID #: BR-100-086
• Status: Recruiting
• Phase: Phase 4
• First received: November 1, 2011
• Last updated: January 13, 2012
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: January 2012
• Source: National Cheng-Kung University Hospital
• Contact: Junne Ming Sung, MD
• Phone: 886-6-2353535
• Email: jmsung[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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).

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	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	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.	18 weeks	No
Secondary	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.	0, 3 weeks, 6 weeks, 9 weeks and 18 weeks	No
Secondary	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.	0, 3 weeks, 6 weeks, 9 weeks and 18 weeks	No
Secondary	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.	0, 3 week, 6 weeks, 9 weeks, 18 weeks	Yes