COVID-19, Liver Diseases, Vaccine Reaction
Conditions
Keywords
SARS-CoV-2 vaccine booster, liver diseases, safety, immunogenicity
Brief summary
Previous studies should that patients with chronic liver diseases, cirrhosis, hepatocellular carcinoma and post-liver-trasplant status had lower immunological response to SARS-CoV-2 vaccines than healthy population. Along with the waning of antibody and emerging SARS-CoV-2 variants, a third dose SARS-CoV-2 booster vaccination is now considered as an effective strategy. Previous studies showed good safety and immunogenicity of the SARS-CoV-2 booster vaccination in healthy population. However, the relevant information in patients with liver diseases need further research. This study (NMCID-CHESS 2201) aimed to investigate the safety and immunogenicity of the SARS-CoV-2 booster vaccination in population with chronic liver diseases
Interventions
None listed
Sponsors
LanZhou University
Xingtai People's Hospital
The Third Central Hospital of Tianjin
The Third People's Hospital of Taiyuan
Lishui Country People's Hospital
Baoding People's Hospital
The Affiliated Hospital of Qingdao University
Affiliated Hospital of Nanjing University of Chinese Medicine
The Fifth People's Hospital of Wuxi
Jincheng People's Hospital
The Sixth Peoples Hospital of Shenyang
Zhenjiang Third Hospital
The Third People's Hospital of Linfen City
The First Affiliated Hospital of Dalian Medical University
The Fourth People's Hospital of Qinghai Province
The Third People's Hospital of Tibet Autonomous Region
The Second Affiliated Hospital of Chongqing Medical University
Peking University Health Science Center
The Affiliated Hospital Of Southwest Medical University
Huashan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously vaccinated with two doses of SARS-CoV-2 vaccines and planning to get booster vaccination. * Clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver diseases, cirrhosis, liver cancer, liver transplant subjects, etc. * Understanding and willing to comply with the study procedures and provides written informed consent.
Exclusion criteria
* Pregnancy or lactation. * Active or known history of SARS-CoV-2 infection. * Diseases causing immunosuppressive or immunodeficient status or autoimmune diseases. * A history of discontinuing anti-HBV agents in recent three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of neutralizing antibody serological conversion after the booster vaccination | Fourteen to 90 days after the booster vaccine | Neutralizing antibody serological conversion is defined as a change from seronegative at baseline to seropositive or a four-fold titre increase if the participant was seropositive at baseline. |
| Number and rate of all solicited and non-solicited adverse events | Up to 28 days after booster vaccine injection | First 7 days after the booster dose, participants will be required to record and be interviewed for adverse events; from day 8 to day 28 after booster dose, safety data were collected by spontaneous report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and rate of abnormal laboratory testing results after the booster vaccination | Up to 28 days after after booster vaccine injection | Abnormal laboratory testing results will be record and grade for severity. |
| Concentration and titre of neutralizing antibody after booster vaccination | Baseline and 14 days, 28 days, 90 days, and 180 days after the booster vaccination | The results will be generated from competitive binding immuoenzymatic capture chemiluminescence immunoassays |
Countries
China
Contacts
Primary ContactJingwen Ai
Backup ContactQiran Zhang
Outcome results
None listed