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

• Conditions: Liver Diseases; Adverse Reaction to Vaccine; Covid19
• Interventions: Biological: SARS-COV-2 VACCINE

• Registration Number: NCT05007665
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief 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.

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Study First Posted: 2021-08-16
• Last Update Posted: 2021-08-16
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Healthy group were as follows: no history of hepatitis, no history of liver cirrhosis, no history of liver cancer and receiving the whole-course COVID-19 vaccination.
2. Patients with chronic liver disease diagnosed clinically or pathologically and receiving the whole-course COVID-19 vaccination.

Exclusion Criteria

1. Patients previously diagnosed or with a history of contact with confirmed cases
2. Patients with contraindications for vaccination.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Liver Diseases Patients/Healthy People	SARS-COV-2 VACCINE	Chronic hepatitis (B OR C) , autoimmune hepatitis, liver cirrhosis, primary hepatocellular carcinoma

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events after injection.	48 weeks after vaccination	The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.

Secondary Outcome Measures

Name	Time	Method
Titer and duration of COVID-19 antibody production after vaccination	48 weeks after vaccination	The titer and duration of COVID-19 antibody were produced at 48 weeks after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with chronic liver disease.

Trial Locations

Locations (1)

The second affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China