ESRD — Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients
Citation(s)
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.
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. Erratum in: MMWR Recomm Rep. 2013 Nov 15;62(45):906.
Cohen G, Hörl WH Immune dysfunction in uremia—an update. Toxins (Basel). 2012 Oct 24;4(11):962-90. doi: 10.3390/toxins4110962. Review.
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. Review.
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.
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. Epub 2016 Jul 8. Review.
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. Epub 2007 Aug 29.
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. Retraction in: J Am Soc Nephrol. 2014 Mar;25(3):645.
Rautenberg P, Proppe D, Schütte 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.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.