Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study

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/m 2 (IQR 23.8–28.1 kg/m 2 ). 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. 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.

Safety and immunogenicity of SARS-CoV-2 vaccines in Chinese patients with cirrhosis: a prospective multicenter study

“…The previous history of SARS-CoV-2 infection was confirmed by reverse-transcription polymerase chain reaction, and antigen or antibody tests mainly using naso-oropharyngeal swabs. Cirrhosis was confirmed in all participants using clinical or biochemical evidence (splenomegaly, platelet count, ascites, hepatic encephalopathy, and/or variceal bleeding), FibroScan®, liver imaging, endoscopy or liver biopsy [ 8 , 11 – 14 ]. The splenomegaly was defined as the largest dimension of more than 11 cm.…”

Patients with Liver Cirrhosis Show High Immunogenicity upon COVID-19 Vaccination but Develop Premature Deterioration of Antibody Titers

“…Other studies analyzing immunogenicity in patients with impaired liver function showed similar results. In patients with non-alcoholic fatty liver disease (NAFLD), seropositivity rates of 95.5% were described [ 20 ]. In patients with liver cirrhosis, Thuluvath et al reported a seroconversion of 95.9% in a group of 79 patients with liver cirrhosis [ 21 ], and Calleri et al observed a seroconversion rate of 94.4% in 89 pre-transplant patients [ 22 ].…”

The intestinal microbiota and improving the efficacy of COVID-19 vaccinations

“…The low immunogenicity of COVID-19 vaccine in liver transplantation were associated with factors of age, renal function and immunosuppressive medications ( Rabinowich et al, 2021 ). In contrast, a study demonstrated that NAFLD did not affect the efficacy of a COVID-19 vaccines ( Wang et al, 2021 , Wang et al, 2021 , Wang et al, 2021 ). It may be necessary to distinguish mild and severe liver diseases on vaccine efficacy ( Cornberg and Eberhardt, 2021 ).…”

“…1.351, P1 of B.1.1.28 and B.1.167 ( Jia and Gong, 2021 ). It has also been shown that antibodies isolated from natural infections and vaccinations are less effective against variants ( Chen et al, 2021 , Hoffmann et al, 2021 , Jia and Gong, 2021 , Khoury et al, 2021 , Röltgen et al, 2021 , Wang et al, 2021 , Wang et al, 2021 , Wang et al, 2021 ). A meta-analysis showed that neutralizing antibodies induced by natural infections or vaccinations had 1.5-fold reduction against B.1.1.7, 8.7-fold reduction against B1.351 and 5-fold reduction against P1 ( Chen et al, 2021 , Chen et al, 2021 ).…”