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.
Keywords: Child–Pugh; Compensated cirrhosis; Coronavirus disease 2019; Decompensated cirrhosis; Hepatitis B virus; Immunogenicity; Safety; Severe acute respiratory syndrome coronavirus 2; Vaccination; Vaccine.
【저자키워드】 severe acute respiratory syndrome coronavirus 2, Coronavirus disease 2019, Vaccine, vaccination, immunogenicity, Safety, compensated cirrhosis, Hepatitis B virus, Child–Pugh, Decompensated cirrhosis, 【초록키워드】 COVID-19, coronavirus disease, neutralizing antibody, Vaccine, coronavirus, fatigue, Local, China, COVID-19 vaccines, COVID-19 vaccination, cirrhosis, Patient, Mild, multicenter, disease, positive rate, patients, SARS-CoV-2 neutralizing antibody, inactivated, ALT, dose, Adverse reaction, Safe, GRADE, alanine aminotransferase, acute respiratory syndrome, Factor, Adverse, second dose, Elevation, participant, independent risk factor, serum sample, Child-Pugh score, limit, event, injection site pain, enrolled, defined, tested, analyzed, collected, reported, groups, were recorded, compensated, systemic adverse event, ULN, 【제목키워드】 SARS-CoV-2 vaccine, multicenter, Chinese patient,