NCT05007665

Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver Diseases

Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver （CQMU）

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as immune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), those patients has a higher risk of infection than the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. To evaluate the safety and effectiveness of COVID-19 vaccine in those patients with chronic liver diseases, and to guide the COVID-19 vaccination more scientifically, reasonably and effectively, this study was carried out.

Detailed description

Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as autoimmune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), those patients has a higher risk of infection than the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 / influenza vaccine can effectively prevent COVID-19 / influenza virus infection and delay or prevent patients from developing into critical illness and reduce mortality. The safety and effectiveness of COVID-19 / influenza vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively. The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University. Patients with contraindications for vaccination will be excluded. The detected indexes included blood routine test, liver function, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and patients with chronic liver disease before and after vaccination ( 1, 3, 6, 12 months after vaccination). The adverse reactions related to the vaccine were recorded.

Conditions

• Liver Diseases
• Covid19
• Adverse Reaction to Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	SARS-COV-2 VACCINE	the antibody titer and adverse reactions were observed.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-06-30
• Completion: 2023-12-30
• First posted: 2021-08-16
• Last updated: 2021-08-16

Locations

1 site across 1 country: China