TY - JOUR
T1 - Comparative safety of high-dose versus standard-dose influenza vaccination in patients with end-stage renal disease
AU - Layton, J. Bradley
AU - McGrath, Leah J.
AU - Sahrmann, John M.
AU - Ma, Yinjiao
AU - Dharnidharka, Vikas R.
AU - O'Neil, Caroline
AU - Weber, David J.
AU - Butler, Anne M.
N1 - Funding Information:
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JBL is an employee of RTI International, an independent, nonprofit research institute that provides research services for governmental and commercial clients, including pharmaceutical companies. LM is an employee of and owns stock in NoviSci, Inc. AMB is supported by a grant from the National Center for Advancing Translational Sciences (NCATS), NIH under award number KL2 TR002346. The other authors report no conflicts.
Funding Information:
The work was supported by the United States National Institutes of Health [grant number 1R21AI38385]. Data programming for this study was conducted by the Center for Administrative Data Research, which is supported in part by the Washington University Institute of Clinical and Translational Sciences grant UL1 TR002345 from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) and by grant number R24 HS19455 through the Agency for Healthcare Research and Quality (AHRQ). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Funding Information:
The work was supported by the United States National Institutes of Health [grant number 1R21AI38385 ]. Data programming for this study was conducted by the Center for Administrative Data Research, which is supported in part by the Washington University Institute of Clinical and Translational Sciences grant UL1 TR002345 from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) and by grant number R24 HS19455 through the Agency for Healthcare Research and Quality (AHRQ). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Publisher Copyright:
© 2020 Elsevier Ltd
PY - 2020/7/14
Y1 - 2020/7/14
N2 - Background: High-dose influenza vaccine (HDV) is an alternative vaccination strategy in patients with end-stage renal disease (ESRD), though the safety of HDV has not been evaluated in this population. The objective of this study was to estimate the relative occurrence of adverse vaccine reactions in patients with ESRD following vaccination with HDV compared with standard-dose influenza vaccine (SDV). Methods: Using data from the United States Renal Data System, we identified patients with ESRD aged ≥ 65 years at influenza vaccination during yearly influenza seasons from 2010 through 2016. Patients were followed after vaccination to observe serious (anaphylaxis, angioedema, seizure, encephalopathy, Guillain-Barré syndrome [GBS], and short-term, all-cause mortality) and milder (urticaria/hives, rash, pain in limb, cellulitis, myalgia/myositis, fever, nausea and vomiting, diarrhea, and syncope) adverse events. Propensity score-weighted hazard ratios (HRs) and 95% confidence intervals (CIs) for HDV versus SDV were estimated with Cox proportional hazards models. Results: Of 520,876 vaccinations observed (mean age = 74.7 years at vaccination; 63% white race), 7.4% were HDV. For serious events, the weighted HRs were null for seizure, encephalopathy, and mortality and inestimable due to too few cases for anaphylaxis, angioedema, and GBS. For milder vaccine reactions, the weighted HRs demonstrated generally increased risks in the HDV group, including rash (HR = 1.86; 95% CI, 1.34–2.57), diarrhea (HR = 1.26; 95% CI, 1.07–1.50), pain in limb (HR = 1.23; 95% CI, 1.12–1.34), and myalgia/myositis (HR = 1.16; 95% CI, 1.04–1.30). Conclusions: The risks of serious adverse events were low and similar between treatment groups; however, HDV recipients had increased risks of several milder adverse events compared with SDV recipients, consistent with clinical trial findings in the general population of older adults. These results add important information to inform the risk-benefit tradeoff of the use of HDV versus SDV in patients with ESRD.
AB - Background: High-dose influenza vaccine (HDV) is an alternative vaccination strategy in patients with end-stage renal disease (ESRD), though the safety of HDV has not been evaluated in this population. The objective of this study was to estimate the relative occurrence of adverse vaccine reactions in patients with ESRD following vaccination with HDV compared with standard-dose influenza vaccine (SDV). Methods: Using data from the United States Renal Data System, we identified patients with ESRD aged ≥ 65 years at influenza vaccination during yearly influenza seasons from 2010 through 2016. Patients were followed after vaccination to observe serious (anaphylaxis, angioedema, seizure, encephalopathy, Guillain-Barré syndrome [GBS], and short-term, all-cause mortality) and milder (urticaria/hives, rash, pain in limb, cellulitis, myalgia/myositis, fever, nausea and vomiting, diarrhea, and syncope) adverse events. Propensity score-weighted hazard ratios (HRs) and 95% confidence intervals (CIs) for HDV versus SDV were estimated with Cox proportional hazards models. Results: Of 520,876 vaccinations observed (mean age = 74.7 years at vaccination; 63% white race), 7.4% were HDV. For serious events, the weighted HRs were null for seizure, encephalopathy, and mortality and inestimable due to too few cases for anaphylaxis, angioedema, and GBS. For milder vaccine reactions, the weighted HRs demonstrated generally increased risks in the HDV group, including rash (HR = 1.86; 95% CI, 1.34–2.57), diarrhea (HR = 1.26; 95% CI, 1.07–1.50), pain in limb (HR = 1.23; 95% CI, 1.12–1.34), and myalgia/myositis (HR = 1.16; 95% CI, 1.04–1.30). Conclusions: The risks of serious adverse events were low and similar between treatment groups; however, HDV recipients had increased risks of several milder adverse events compared with SDV recipients, consistent with clinical trial findings in the general population of older adults. These results add important information to inform the risk-benefit tradeoff of the use of HDV versus SDV in patients with ESRD.
KW - Adverse reactions
KW - Hemodialysis
KW - High-dose
KW - Influenza vaccines
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85086649487&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2020.06.020
DO - 10.1016/j.vaccine.2020.06.020
M3 - Article
C2 - 32565346
AN - SCOPUS:85086649487
SN - 0264-410X
VL - 38
SP - 5178
EP - 5186
JO - Vaccine
JF - Vaccine
IS - 33
ER -