Safety and Immunogenicity of COVID-19 Vaccine Booster in Patients With Liver Diseases
- Conditions
- Vaccine ReactionCOVID-19Liver Diseases
- Registration Number
- NCT05204602
- Lead Sponsor
- Huashan Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (19)
Jincheng People's Hospital
π¨π³Jincheng, Shanxi, China
The Third People's Hospital of Taiyuan
π¨π³Taiyuan, Shanxi, China
The Third Central Hospital of Tianjin
π¨π³Tianjin, Tianjin, China
The Third People's Hospital of Tibet Autonomous Region
π¨π³Lhasa, Tibet, China
Lishui People's Hospital
π¨π³Lishui, Zhejiang, China
Huashan Hospital
π¨π³Shanghai, Shanghai, China
The First Affiliated Hospital of Dalian Medical University
π¨π³Dalian, Liaoning, China
The Fourth People's Hospital of Qinghai Province
π¨π³Xining, Qinghai, China
the Affiliated Hospital of Qingdao University
π¨π³Qingdao, Shandong, China
The Sixth Peoples Hospital of Shenyang
π¨π³Shenyang, Liaoning, China
The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University
π¨π³Wuxi, Jiangsu, China
The Third People's Hospital of Linfen City
π¨π³Linfen, Shanxi, China
Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
π¨π³Nanjing, Jiangsu, China
The First Hospital of Lanzhou University
π¨π³Lanzhou, Gansu, China
Xingtai People's Hospital
π¨π³Xingtai, Heibei, China
Zhenjiang Third Hospital Affiliated to Jiangsu University
π¨π³Zhenjiang, Jiangsu, China
The Second Affiliated Hospital of Chongqing Medical University
π¨π³Chongqing, Chongqing, China
Baoding people's Hospital
π¨π³Baoding, Hebei, China
The Affiliated Hospital of Southwest Medical University
π¨π³Luzhou, Sichuan, China