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| Name | Class |
|---|---|
| Bhumirajanagarindra Kidney Institute, Thailand | OTHER |
| Ministry of Health, Thailand | OTHER_GOV |
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This study was a randomized controlled trial to investigate the immune response of influenza vaccines when doses were increased. and a second vaccination together with an increase in the amount of vaccine in patients with chronic kidney disease receiving hemodialysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ้healthy subject with standard dose trivalent influenza vaccine | Other | ้healthy volunteer that received Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) ( 0.5 ml : 15 mcg/strain) |
|
| ESRD patient with standard dose trivalent influenza vaccine | Active Comparator | ESRD patient that received Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) ( 0.5 ml : 15 mcg/strain) |
|
| ESRD patient with double dose trivalent influenza vaccine | Experimental | ESRD patient that received Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) total 1 ml ( 1 ml /(30 mcg/strain) |
|
| ESRD patient with double dose - booster trivalent influenza vaccine | Experimental | ESRD patient that received Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) ( 1 ml /(30 mcg/strain) and booster with Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) ( 1 ml /(30 mcg/strain) at next 6 months after first dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) | Biological | study of immunologic response to different dose and duration of Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) |
| Measure | Description | Time Frame |
|---|---|---|
| To compare proportion of seroprotection of different doses of influenza vaccine in hemodialysis patients at month 12 | Patients will receive a blood test to check their immune response to influenza vaccine. (Hemagglutination inhibition assays and activation and/or exhaustion T cell markers, T cell subpopulation by flow cytometry) at month 12 after influenza vaccination. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the prevention of influenza virus infection in different doses of influenza vaccination. | to compare incidence rate of influenza infection in different doses of influenza | 12 months of data collection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angsana Phuphuakrat, MD, PhD | Contact | 6622011581 | angsana.phu@mahidol.ac.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angsana Phuphuakrat | Recruiting | Ratchathewi | ฺBangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25501062 | Background | Chou CY, Wang SM, Liang CC, Chang CT, Liu JH, Wang IK, Hsiao LC, Muo CH, Huang CC, Wang RY. Risk of pneumonia among patients with chronic kidney disease in outpatient and inpatient settings: a nationwide population-based study. Medicine (Baltimore). 2014 Dec;93(27):e174. doi: 10.1097/MD.0000000000000174. | |
| 19996006 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D000954 | Antigens, Surface |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Collins AJ, Foley RN, Gilbertson DT, Chen SC. The state of chronic kidney disease, ESRD, and morbidity and mortality in the first year of dialysis. Clin J Am Soc Nephrol. 2009 Dec;4 Suppl 1:S5-11. doi: 10.2215/CJN.05980809. |
| 21273232 | Background | Viasus D, Garcia-Vidal C, Cruzado JM, Adamuz J, Verdaguer R, Manresa F, Dorca J, Gudiol F, Carratala J. Epidemiology, clinical features and outcomes of pneumonia in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Sep;26(9):2899-906. doi: 10.1093/ndt/gfq798. Epub 2011 Jan 27. |
| 11742917 | Background | Sarnak MJ, Jaber BL. Pulmonary infectious mortality among patients with end-stage renal disease. Chest. 2001 Dec;120(6):1883-7. doi: 10.1378/chest.120.6.1883. |
| 23202302 | Background | Cohen G, Horl WH. Immune dysfunction in uremia—an update. Toxins (Basel). 2012 Oct 24;4(11):962-90. doi: 10.3390/toxins4110962. |
| 11169012 | Background | Girndt M, Sester M, Sester U, Kaul H, Kohler H. Molecular aspects of T- and B-cell function in uremia. Kidney Int Suppl. 2001 Feb;78:S206-11. doi: 10.1046/j.1523-1755.2001.59780206.x. |
| 13679482 | Background | Anding K, Gross P, Rost JM, Allgaier D, Jacobs E. The influence of uraemia and haemodialysis on neutrophil phagocytosis and antimicrobial killing. Nephrol Dial Transplant. 2003 Oct;18(10):2067-73. doi: 10.1093/ndt/gfg330. |
| 17728708 | Background | Lim WH, Kireta S, Leedham E, Russ GR, Coates PT. Uremia impairs monocyte and monocyte-derived dendritic cell function in hemodialysis patients. Kidney Int. 2007 Nov;72(9):1138-48. doi: 10.1038/sj.ki.5002425. Epub 2007 Aug 29. |
| 10910448 | Background | Sester U, Sester M, Hauk M, Kaul H, Kohler H, Girndt M. T-cell activation follows Th1 rather than Th2 pattern in haemodialysis patients. Nephrol Dial Transplant. 2000 Aug;15(8):1217-23. doi: 10.1093/ndt/15.8.1217. |
| 10727545 | Background | Fernandez-Fresnedo G, Ramos MA, Gonzalez-Pardo MC, de Francisco AL, Lopez-Hoyos M, Arias M. B lymphopenia in uremia is related to an accelerated in vitro apoptosis and dysregulation of Bcl-2. Nephrol Dial Transplant. 2000 Apr;15(4):502-10. doi: 10.1093/ndt/15.4.502. |
| 19406979 | Background | Meier P, Golshayan D, Blanc E, Pascual M, Burnier M. Oxidized LDL modulates apoptosis of regulatory T cells in patients with ESRD. J Am Soc Nephrol. 2009 Jun;20(6):1368-84. doi: 10.1681/ASN.2008070734. Epub 2009 Apr 30. |
|
| 23516462 | Background | Wang IK, Lin CL, Lin PC, Liang CC, Liu YL, Chang CT, Yen TH, Morisky DE, Huang CC, Sung FC. Effectiveness of influenza vaccination in patients with end-stage renal disease receiving hemodialysis: a population-based study. PLoS One. 2013;8(3):e58317. doi: 10.1371/journal.pone.0058317. Epub 2013 Mar 13. |
| 22493462 | Background | McGrath LJ, Kshirsagar AV, Cole SR, Wang L, Weber DJ, Sturmer T, Brookhart MA. Influenza vaccine effectiveness in patients on hemodialysis: an analysis of a natural experiment. Arch Intern Med. 2012 Apr 9;172(7):548-54. doi: 10.1001/archinternmed.2011.2238. |
| 12631142 | Background | Gilbertson DT, Unruh M, McBean AM, Kausz AT, Snyder JJ, Collins AJ. Influenza vaccine delivery and effectiveness in end-stage renal disease. Kidney Int. 2003 Feb;63(2):738-43. doi: 10.1046/j.1523-1755.2003.00787.x. |
| 26247435 | Background | Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 Influenza Season. MMWR Morb Mortal Wkly Rep. 2015 Aug 7;64(30):818-25. doi: 10.15585/mmwr.mm6430a3. |
| 24048214 | Background | Centers for Disease Control and Prevention (CDC). Prevention and control of seasonal influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices--United States, 2013-2014. MMWR Recomm Rep. 2013 Sep 20;62(RR-07):1-43. |
| 24421306 | Background | Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, Bousvaros A, Dhanireddy S, Sung L, Keyserling H, Kang I; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014 Feb;58(3):309-18. doi: 10.1093/cid/cit816. |
| 26187260 | Background | DiazGranados CA, Dunning AJ, Robertson CA, Talbot HK, Landolfi V, Greenberg DP. Efficacy and immunogenicity of high-dose influenza vaccine in older adults by age, comorbidities, and frailty. Vaccine. 2015 Aug 26;33(36):4565-71. doi: 10.1016/j.vaccine.2015.07.003. Epub 2015 Jul 14. |
| 2512137 | Background | Rautenberg P, Proppe D, Schutte A, Ullmann U. Influenza subtype-specific immunoglobulin A and G responses after booster versus one double-dose vaccination in hemodialysis patients. Eur J Clin Microbiol Infect Dis. 1989 Oct;8(10):897-900. doi: 10.1007/BF01963779. |
| 27392026 | Background | Liao Z, Xu X, Liang Y, Xiong Y, Chen R, Ni J. Effect of a booster dose of influenza vaccine in patients with hemodialysis, peritoneal dialysis and renal transplant recipients: A systematic literature review and meta-analysis. Hum Vaccin Immunother. 2016 Nov;12(11):2909-2915. doi: 10.1080/21645515.2016.1201623. Epub 2016 Jul 8. |
| Related Info | View source |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D000941 |
| Antigens |
| D001685 | Biological Factors |