PMID- 36084024
OWN - NLM
STAT- MEDLINE
DCOM- 20220913
LR  - 20220922
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 17
IP  - 9
DP  - 2022
TI  - Safety of ChAdOx1 nCoV-19 vaccination in patients with end-stage renal disease on 
      hemodialysis.
PG  - e0273676
LID - 10.1371/journal.pone.0273676 [doi]
LID - e0273676
AB  - BACKGROUND: COVID-19 vaccination is essential. However, no study has reported 
      adverse events (AEs) after ChAdOx1 nCoV-19 vaccination in patients with end-stage 
      renal disease (ESRD) on hemodialysis (HD). This study investigated the AEs within 
      30-days after the first dose of ChAdOx1 nCoV19 (Oxford-AstraZeneca) in ESRD 
      patients on HD. METHODS AND FINDINGS: A total of 270 ESRD patients on HD were 
      enrolled in this study. To determine the significance of vascular access 
      thrombosis (VAT) post vaccination, we performed a self-controlled case study 
      (SCCS) analysis. Of these patients, 38.5% had local AEs; local pain (29.6%), 
      tenderness (28.9%), and induration (15.6%) were the most common. Further, 62.2% 
      had systemic AEs; fatigue (41.1%), feverishness (20%), and lethargy (19.9%) were 
      the most common. In addition, post-vaccination thirst affected 18.9% of the 
      participants with female predominance. Younger age, female sex, and diabetes 
      mellitus were risk factors for AEs. Five patients had severe AEs, including fever 
      (n = 1), herpes zoster (HZ) reactivation (n = 1), and acute VAT (n = 3). However, 
      the SCCS analysis revealed no association between vaccination and VAT; the 
      incidence rate ratio (IRR)-person ratio was 0.56 (95% CI 0.13-2.33) and 0.78 (95% 
      CI 0.20-2.93) [IRR-event ratio 0.78 (95% CI 0.15-4.10) and 1.00 (95% CI 
      0.20-4.93)] in the 0-3 months and 3-6 months period prior to vaccination, 
      respectively. CONCLUSIONS: Though some ESRD patients on HD had local and systemic 
      AEs after first-dose vaccination, the clinical significance of these symptoms was 
      minor. Our study confirmed the safety profile of ChAdOx1 nCoV-19 in HD patients 
      and presented a new viewpoint on vaccine-related AEs. The SCCS analysis did not 
      find an elevated risk of VAT at 1 month following vaccination. Apart from VAT, 
      other vaccine-related AEs, irrespective of local or systemic symptoms, had minor 
      clinical significance on safety issues. Nonetheless, further coordinated, 
      multi-center, or registry-based studies are needed to establish the causality.
FAU - Yang, I-Ning
AU  - Yang IN
AD  - Department of Nephrology, Chi-Mei Medical Center, Tainan, Taiwan.
FAU - Lu, Chin-Li
AU  - Lu CL
AD  - Graduate Institute of Food Safety, College of Agriculture and Natural Resources, 
      National Chung Hsing University, Taichung, Taiwan.
FAU - Tang, Hung-Jen
AU  - Tang HJ
AD  - Department of Infectious Diseases, Chi-Mei Medical Center, Tainan, Taiwan.
FAU - Kuo, Yu-Chi
AU  - Kuo YC
AD  - Department of Internal Medicine, Nephrology Division, Chi-Mei Hospital, Chiali, 
      Tainan, Taiwan.
FAU - Tsai, Li-Hwa
AU  - Tsai LH
AD  - Department of Internal Medicine, Nephrology Division, Chi-Mei Hospital, Chiali, 
      Tainan, Taiwan.
FAU - Tu, Kuan Chieh
AU  - Tu KC
AD  - Department of Internal Medicine, Chi-Mei Medical Center, Tainan, Taiwan.
FAU - Wang, Jhi-Joung
AU  - Wang JJ
AD  - Department of Medical Research, Chi-Mei Medical Center, Tainan, Taiwan.
FAU - Chien, Chih-Chiang
AU  - Chien CC
AUID- ORCID: 0000-0001-7761-763X
AD  - Department of Nephrology, Chi-Mei Medical Center, Tainan, Taiwan.
LA  - eng
SI  - Dryad/10.5061/dryad.47d7wm3h3
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220909
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (COVID-19 Vaccines)
RN  - B5S3K2V0G8 (ChAdOx1 nCoV-19)
SB  - IM
MH  - *COVID-19/prevention & control
MH  - *COVID-19 Vaccines/adverse effects
MH  - ChAdOx1 nCoV-19
MH  - Female
MH  - Humans
MH  - *Kidney Failure, Chronic/etiology/therapy
MH  - Male
MH  - Renal Dialysis
MH  - Vaccination/adverse effects
PMC - PMC9462771
COIS- The authors have declared that no competing interests exist.
EDAT- 2022/09/10 06:00
MHDA- 2022/09/14 06:00
PMCR- 2022/09/09
CRDT- 2022/09/09 14:13
PHST- 2022/05/20 00:00 [received]
PHST- 2022/08/11 00:00 [accepted]
PHST- 2022/09/09 14:13 [entrez]
PHST- 2022/09/10 06:00 [pubmed]
PHST- 2022/09/14 06:00 [medline]
PHST- 2022/09/09 00:00 [pmc-release]
AID - PONE-D-22-14735 [pii]
AID - 10.1371/journal.pone.0273676 [doi]
PST - epublish
SO  - PLoS One. 2022 Sep 9;17(9):e0273676. doi: 10.1371/journal.pone.0273676. 
      eCollection 2022.