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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05007665
Acronym
SIMPLE
Enrollment
2000
Registered
2021-08-16
Start date
2021-07-01
Completion date
2023-12-30
Last updated
2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Reaction to Vaccine, Covid19, Liver Diseases

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.

Interventions

the antibody titer and adverse reactions were observed.

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with adverse events after injection.4 weeks after vaccinationThe vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.

Secondary

MeasureTime frameDescription
Titer and duration of COVID-19 antibody production after vaccination4 weeks after vaccinationThe titer and duration of COVID-19 antibody were produced at 4 weeks

Countries

China

Contacts

Primary ContactDACHUAN CAI, PH D
597521685@qq.com18323409779
Backup ContactDAZHI ZHANG, PH D
dzhzhang@yahoo.com13452382818

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026