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

Abstract

Background Data on safety and immunogenicity of coronavirus disease 2019 (COVID-19) vaccination in patients with compensated (C-cirrhosis) and decompensated cirrhosis (D-cirrhosis) are limited. Methods In this prospective multicenter study, adult participants with C-cirrhosis and D-cirrhosis were enrolled and received two doses of inactivated whole-virion COVID-19 vaccines. Adverse events were recorded within 14 days after any dose of vaccination, and serum samples of enrolled patients were collected and tested for SARS-CoV-2 neutralizing antibodies at least 14 days after the second dose. Risk factors for negative neutralizing antibody were analyzed. Results In total, 553 patients were enrolled from 15 centers in China, including 388 and 165 patients with C-cirrhosis and D-cirrhosis. The vaccines were well tolerated, most adverse reactions were mild and transient, and injection site pain (23/388 [5.9%] vs 9/165 [5.5%]) and fatigue (5/388 [1.3%] vs 3/165 [1.8%]) were the most frequently local and systemic adverse events in both the C-cirrhosis and D-cirrhosis groups. Overall, 4.4% (16/363) and 0.3% (1/363) of patients were reported Grades 2 and 3 alanine aminotransferase (ALT) elevations (defined as ALT > 2 upper limit of normal [ULN] but ≤ 5 ULN, and ALT > 5 ULN, respectively). The positive rates of COVID-19 neutralizing antibodies were 71.6% (278/388) and 66.1% (109/165) in C-cirrhosis and D-cirrhosis groups. Notably, Child–Pugh score of B and C levels was an independent risk factor of negative neutralizing antibody. Conclusions Inactivated COVID-19 vaccinations are safe with acceptable immunogenicity in cirrhotic patients, and Child–Pugh score of B and C levels is associated with hyporesponsive to COVID-19 vaccination.

Omicron infections profile and vaccination status among 1881 liver transplant recipients: a multi-centre retrospective cohort

“…Although the data on inactivated vaccines in the LT population are not yet sufficient, studies show a decreased immunogenicity in patients with other chronic liver diseases (e.g. cirrhosis and fatty liver) compared to healthy individuals [ 16 , 32–34 ].…”

“…Previous studies reported that 27%−51% vaccinated LT patients had systemic AEs (mostly fatigue and headache) following two doses of vaccines [ 15 , 35 , 36 ]. Compared with liver cirrhosis and other chronic liver diseases [ 16 , 17 ], LT patients had a relatively higher proportion of systemic AEs, which might be due to their impaired immune systems.…”

“…The safety assessment included profiling local (swelling and scleroma) and systemic adverse events (AEs) (fever, cough, fatigue, myalgia, nausea, and diarrhea). According to our previous reports [ 16 , 17 ], abnormal liver function was defined as having at least one of the following liver function parameters: total bilirubin (>17.1 mol/L), alanine aminotransferase (ALT, >40 U/L), aspartate aminotransferase (>40 U/L), and γ -glutamyl transpeptidase (GGT, >50 U/L).…”

Analysis of neutralizing antibody to COVID-19 vaccine in hospitalized patients with liver dysfunction

“…Zheng Xin [5] and other studies [9] also found that female participants developed higher concentrations of NAb compared to male vaccinees. In a study of a population with cirrhosis, Wenhong Zhang [10] and his colleages found that Child-Pugh score of B and C levels is associated with hyporesponsive to COVID-19 vaccination. However, in our study, the presence or absence of cirrhosis was not found to be associated with niether seropositivity nor titer level of NAbs, possibly due to the relatively small number of patients with cirrhosis observed in our study.…”

Immunogenicity of a third dose of inactivated COVID-19 vaccine in people living with HIV-1, HBV, and tuberculosis during the Omicron variant epidemic: A cross-sectional study

“…It has been known that the immunogenicity of the COVID-19 mRNA vaccine was higher than the inactivated vaccine in normal and immunocompromised patients 2 , 5 , 6 . One previous study revealed that the antibodies (Abs) of two doses of inactivated vaccine immunization peaked at ∼1 month in cirrhosis people and significantly declined between month 3 and 6 7 . Even though some individuals’ serum IgG and neutralizing antibodies (NAbs) declined substantially or were negative after receiving a second dose of inactivated vaccine injection, SARS-CoV-2 specific memory B and T cells can persist in blood until month 5, and a third vaccination could induce robust humoral and cellular immune recall responses 3 .…”