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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the immunogenicity profiles of the AdimFlu-S | Experimental | 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. |
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| The safety outcome of the vaccine | No Intervention | Any adverse effect, including systemic or local site, will be recorded during the study period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdimFlu-S | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junne Ming Sung, MD | Contact | 886-6-2353535 | 2594 | jmsung@mail.ncku.edu.tw |
| Yu Tzu Chang, MD and Msc | Contact | 886-6-2353535 | 2593 | kangxiemperor@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Recruiting | Tainan | Taiwan | 704 | Taiwan |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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|
| 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 |
| 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 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |