Safety and Immunogenicity of SARS-CoV-2 Vaccines in Patients With Chronic Liver Diseases (CHESS-NMCID 2101): A Multicenter Study

Abstract

Background and aims We aim to assess the safety and immunogenicity of inactivated whole-virion SARS-CoV-2 vaccines in patients with chronic liver diseases (CLD) in this study. Methods This was a prospective, multi-center, open-label study. Participants aged over 18 years with confirmed CLD and healthy volunteers were enrolled. All participants received 2 doses of inactivated whole-virion SARS-CoV-2 vaccines. Adverse reactions were recorded within 14 days after any dose of SARS-CoV-2 vaccine, laboratory testing results were collected after the second dose, and serum samples of enrolled subjects were collected and tested for SARS-CoV-2 neutralizing antibodies at least 14 days after the second dose. Results A total of 581 participants (437 patients with CLD and 144 healthy volunteers) were enrolled from 15 sites in China. Most adverse reactions were mild and transient, and injection site pain (36 [8.2%]) was the most frequently reported adverse event. Three participants had Grade 3 aminopherase elevation (defined as alanine aminopherase>5 upper limits of normal) after the second dose of inactivated whole-virion SARS-CoV-2 vaccination, and only one of them was judged as severe adverse event potentially related to SARS-CoV-2 vaccination. The positive rates of SARS-CoV-2 neutralizing antibodies were 76.8% in non-cirrhotic CLD group, 78.9% in compensated cirrhotic group, 76.7% in decompensated cirrhotic group (P=0.894 among CLD subgroups) and 90.3% in healthy controls (P=0.008 versus CLD group). Conclusion Inactivated whole-virion SARS-CoV-2 vaccines are safe in patients with CLD. Patients with CLD had lower immunological response to SARS-CoV-2 vaccines than healthy population. The immunogenicity is similarly low in non-cirrhotic CLD, compensated cirrhosis and decompensated cirrhosis.

Immunogenicity of Inactivated SARS-CoV-2 Vaccines in Patients With Rheumatoid Arthritis: A Case Series

“…Whether there is a correlation between age and NAb inhibition rate produced by inactivated vaccine needs to be further verified by expanding the sample size. In addition, previous studies have shown that males had lower serological response to SARS-CoV-2 vaccination ( 38 ). Male gender had been implicated in the poor vaccination responsiveness in general population ( 39 – 41 ).…”

Breakthrough SARS-CoV-2 Infection Outcomes in Vaccinated Patients with Chronic Liver Disease and Cirrhosis: A National COVID Cohort Collaborative Study

“…While this finding was initially surprising, it is congruent with antibody response studies of patients with and without cirrhosis to SARS-CoV-2 vaccinations, which showed that there were similar rates of neutralizing antibodies generated in CLD patients regardless of presence of cirrhosis. 8,9…”

“…5–7 Recent studies showed that 22.2% of patients with chronic liver diseases (CLD) who received whole virion SARS-Cov-2 vaccines generated no antibody responses and that 24.0% of those who received messenger ribonucleic acid-based (mRNA) SARS-CoV-2 vaccines generated poor [defined as <250U/mL] antibody responses. 8,9 Moreover, multiple previous studies in various large cohorts have demonstrated that SARS-CoV-2 infection in patients with cirrhosis is associated with higher rates of morbidity and mortality. 10–14 These data highlight the growing importance of optimizing vaccination strategies for SARS-CoV-2 infection in this vulnerable patient population.…”

Gastroenterology 2022: Groundhog Day

“…Patients with inflammatory bowel disease (IBD) treated with infliximab were demonstrated to have attenuated antibody responses, 3 as did patients post liver transplantation 4 and those with chronic liver disease. 5 Subsequently, the British Society of Gastroenterology (BSG) has recommended and advocated for booster dosing in these cohorts. 6 As healthcare professionals, we have a duty to promote vaccination in our patient interactions and to continue to contribute to ongoing efforts determining optimal vaccine strategy for the benefit of our patients.…”

“…However, we have observed suboptimal vaccine responses in some of our gastroenterology patient cohorts. Patients with inflammatory bowel disease (IBD) treated with infliximab were demonstrated to have attenuated antibody responses,3 as did patients post liver transplantation4 and those with chronic liver disease 5. Subsequently, the British Society of Gastroenterology (BSG) has recommended and advocated for booster dosing in these cohorts 6.…”