Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study.
J Hepatol
; 75(2): 439-441, 2021 08.
Article
em En
| MEDLINE
| ID: mdl-33905793
ABSTRACT
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/m2 (IQR 23.8-28.1 kg/m2). The number of adverse reactions within 7 days after each injection and adverse reactions within 28 days totaled 95 (24.9%) and 112 (29.4%), respectively. The most common adverse reactions were injection site pain in 70 (18.4%), followed by muscle pain in 21 (5.5%), and headache in 20 (5.2%). All adverse reactions were mild and self-limiting, and no grade 3 adverse reactions were recorded. Notably, neutralizing antibodies against SARS-CoV-2 were detected in 364 (95.5%) patients with NAFLD. The median neutralizing antibody titer was 32 (IQR 8-64), and the neutralizing antibody titers were maintained.CONCLUSIONS:
The inactivated COVID-19 vaccine appears to be safe with good immunogenicity in patients with NAFLD. LAYSUMMARY:
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Vacinas de Produtos Inativados
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Vacinação
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Anticorpos Neutralizantes
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Hepatopatia Gordurosa não Alcoólica
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Imunogenicidade da Vacina
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COVID-19
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Anticorpos Antivirais
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Limite:
Adult
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Female
/
Humans
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Male
País como assunto:
Asia
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article