Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
Recruitment status was Recruiting
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).
|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|
- 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.
- 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.
|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)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512056
|Contact: Junne Ming Sung, MD||886-6-2353535 ext firstname.lastname@example.org|
|Contact: Yu Tzu Chang, MD and Msc||886-6-2353535 ext email@example.com|
|National Cheng Kung University Hospital||Recruiting|
|Tainan, Taiwan, 704|
|Contact: Junne Ming Sung, MD 886-6-2353535 ext 2594 firstname.lastname@example.org|
|Contact: Yu Tzu Chang, MD and Msc 886-6-2353535 ext 2593 email@example.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|