Clinical trial NCT05007665: Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver Diseases
Official title: Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver （CQMU）
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Covid19
Adverse Reaction to Vaccine
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic liver disease vaccinated with SARS-Cov-2 vaccine.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with adverse events after injection.
timeFrame: 4 weeks after vaccination
measure: Number of participants with adverse events after injection.
timeFrame: 12 weeks after vaccination
measure: Number of participants with adverse events after injection.
timeFrame: 24 weeks after vaccination
measure: Number of participants with adverse events after injection.
timeFrame: 48 weeks after vaccination
Secondary outcomes:
measure: Titer and duration of COVID-19 antibody production after vaccination
timeFrame: 4 weeks after vaccination
measure: Titer and duration of COVID-19 antibody production after vaccination
timeFrame: 12 weeks after vaccination
measure: Titer and duration of COVID-19 antibody production after vaccination
timeFrame: 24 weeks after vaccination
measure: Titer and duration of COVID-19 antibody production after vaccination
timeFrame: 48 weeks after vaccination
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The second affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Hong Ren, PH D
role: PRINCIPAL_INVESTIGATOR
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