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
Study Type
OBSERVATIONAL
Enrollment
1,000
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGBaoding people's Hospital
Baoding, Hebei, China
NOT_YET_RECRUITINGXingtai People's Hospital
Xingtai, Heibei, China
RECRUITINGNanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGThe Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
NOT_YET_RECRUITINGZhenjiang Third Hospital Affiliated to Jiangsu University
Zhenjiang, Jiangsu, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
NOT_YET_RECRUITINGThe Sixth Peoples Hospital of Shenyang
Shenyang, Liaoning, China
NOT_YET_RECRUITINGThe Fourth People's Hospital of Qinghai Province
Xining, Qinghai, China
NOT_YET_RECRUITING...and 9 more locations
Rate of neutralizing antibody serological conversion after the booster vaccination
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.
Time frame: Fourteen to 90 days after the booster vaccine
Number and rate of all solicited and non-solicited adverse events
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.
Time frame: Up to 28 days after booster vaccine injection
Number and rate of abnormal laboratory testing results after the booster vaccination
Abnormal laboratory testing results will be record and grade for severity.
Time frame: Up to 28 days after after booster vaccine injection
Concentration and titre of neutralizing antibody after booster vaccination
The results will be generated from competitive binding immuoenzymatic capture chemiluminescence immunoassays
Time frame: Baseline and 14 days, 28 days, 90 days, and 180 days after the booster vaccination
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