NCT05017805

COVID-19 Vaccines in Patients With Chronic Liver Disease

Safety and Immunogenicity of COVID-19 Vaccines in Patients With Chronic Liver Disease: A Multi-center Prospective Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.

Detailed description

This study is a prospective, open-label clinical trial. A total of 300 patients with different cancers including chronic hepatitis, cirrhosis .All of the patients will further accept 18 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.

Conditions

• Liver Disease Chronic

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccines	One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.

Timeline

• Start date: 2021-08-15
• Primary completion: 2024-08-15
• Completion: 2025-08-15
• First posted: 2021-08-24
• Last updated: 2022-04-22

Locations

1 site across 1 country: China