摘要
Aim:Patients with chronic liver disease(CLD),especially cirrhosis,are at a high risk of severe illness or death from coronavirus disease-2019(COVID-19)and may have a suboptimal immune response to the severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)vaccine.This study aimed to evaluate the safety and immunogenicity of the COVID-19 booster vaccination in patients with CLD.Methods:The study protocol was prospectively registered at ClinicalTrials.gov(No.NCT05204602)after approval by the Ethics Committee.Adult participants with CLD were enrolled in this multicenter prospective study.They completed two doses of the inactivated COVID-19 vaccine and received booster doses at least 6 months later.Adverse reactions were recorded within 14 days after the booster dose.Serum samples of the enrolled patients were collected before and after booster vaccination and tested for SARS-CoV-2 receptor-binding domain(RBD)immunoglobulin G and neutralizing anti-bodies.The chi-squared or Fisher's exact test was used to compare categorical data,and the Mann-Whitney U test was used to compare continuous variables.Two-sided p<0.05 were considered statistically significant.Results:In total,63 patients were enrolled from four hospitals in China,including 29 patients with cirrhosis.The median age of all patients was 55 years,and 61.9%(39/63)were male.The vaccines were well tolerated;most adverse reactions were mild and transient,and injection site pain(6.4%;4/63)and fatigue(3.2%,2/63)were the most frequent local and systemic adverse events.Following the booster vaccination,our results showed that in the whole cohort,the levels and positive rates of anti-RBD IgG and neutralizing antibodies were significantly higher than baseline levels(all p<0.05).Conclusions:The inactivated COVID-19 booster vaccine was safe and significantly increased antibody levels and positivity rates following standard vaccination regimens in patients with CLD,especially those with cirrhosis.
基金
prospectively registered at ClinicalTrials.gov (NCT05204602)after approval by the ethics committee (The Third Central Hospital of Tianjin,No.IRB2021-026-01
Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine,No.KY2021133
Jincheng People's Hospital,No.20210603
Lishui People's Hospital,No.2021[007-01]).
