Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study.
Adult
Antibodies, Neutralizing
/ blood
Antibodies, Viral
/ blood
COVID-19
/ epidemiology
COVID-19 Vaccines
/ administration & dosage
China
/ epidemiology
Female
Humans
Immunogenicity, Vaccine
/ immunology
Male
Non-alcoholic Fatty Liver Disease
/ diagnosis
Outcome Assessment, Health Care
SARS-CoV-2
/ immunology
Vaccination
/ adverse effects
Vaccines, Inactivated
/ administration & dosage
Journal
Journal of hepatology
ISSN: 1600-0641
Titre abrégé: J Hepatol
Pays: Netherlands
ID NLM: 8503886
Informations de publication
Date de publication:
08 2021
08 2021
Historique:
received:
08
04
2021
revised:
18
04
2021
accepted:
20
04
2021
pubmed:
28
4
2021
medline:
27
7
2021
entrez:
27
4
2021
Statut:
ppublish
Résumé
The development of COVID-19 vaccines has progressed with encouraging safety and efficacy data. Concerns have been raised about SARS-CoV-2 vaccine responses in the large population of patients with non-alcoholic fatty liver disease (NAFLD). The study aimed to explore the safety and immunogenicity of COVID-19 vaccination in NAFLD. This multicenter study included patients with NAFLD without a history of SARS-CoV-2 infection. All patients were vaccinated with 2 doses of inactivated vaccine against SARS-CoV-2. The primary safety outcome was the incidence of adverse reactions within 7 days after each injection and overall incidence of adverse reactions within 28 days, and the primary immunogenicity outcome was neutralizing antibody response at least 14 days after the whole-course vaccination. A total of 381 patients with pre-existing NAFLD were included from 11 designated centers in China. The median age was 39.0 years (IQR 33.0-48.0 years) and 179 (47.0%) were male. The median BMI was 26.1 kg/m The inactivated COVID-19 vaccine appears to be safe with good immunogenicity in patients with NAFLD. The development of vaccines against coronavirus disease 2019 (COVID-19) has progressed rapidly, with encouraging safety and efficacy data. This study now shows that the inactivated COVID-19 vaccine appears to be safe with good immunogenicity in the large population of patients with non-alcoholic fatty liver disease.
Sections du résumé
BACKGROUND & AIMS
The development of COVID-19 vaccines has progressed with encouraging safety and efficacy data. Concerns have been raised about SARS-CoV-2 vaccine responses in the large population of patients with non-alcoholic fatty liver disease (NAFLD). The study aimed to explore the safety and immunogenicity of COVID-19 vaccination in NAFLD.
METHODS
This multicenter study included patients with NAFLD without a history of SARS-CoV-2 infection. All patients were vaccinated with 2 doses of inactivated vaccine against SARS-CoV-2. The primary safety outcome was the incidence of adverse reactions within 7 days after each injection and overall incidence of adverse reactions within 28 days, and the primary immunogenicity outcome was neutralizing antibody response at least 14 days after the whole-course vaccination.
RESULTS
A total of 381 patients with pre-existing NAFLD were included from 11 designated centers in China. The median age was 39.0 years (IQR 33.0-48.0 years) and 179 (47.0%) were male. The median BMI was 26.1 kg/m
CONCLUSIONS
The inactivated COVID-19 vaccine appears to be safe with good immunogenicity in patients with NAFLD.
LAY SUMMARY
The development of vaccines against coronavirus disease 2019 (COVID-19) has progressed rapidly, with encouraging safety and efficacy data. This study now shows that the inactivated COVID-19 vaccine appears to be safe with good immunogenicity in the large population of patients with non-alcoholic fatty liver disease.
Identifiants
pubmed: 33905793
pii: S0168-8278(21)00262-2
doi: 10.1016/j.jhep.2021.04.026
pmc: PMC8185617
pii:
doi:
Substances chimiques
Antibodies, Neutralizing
0
Antibodies, Viral
0
COVID-19 Vaccines
0
Vaccines, Inactivated
0
Types de publication
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
439-441Subventions
Organisme : NIGMS NIH HHS
ID : P20 GM130457
Pays : United States
Organisme : NIDDK NIH HHS
ID : P30 DK123704
Pays : United States
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2021 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Conflicts of interest The authors have declared no conflict of interest related to the study. Please refer to the accompanying ICMJE disclosure forms for further details.
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