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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.
This study is a prospective, open-label clinical trial. A total of 300 patients with different cancers including chronic hepatitis, cirrhosis .All of the patients will further accept 18 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 doses of vaccine | Experimental | Covid-19 vaccination on day 0, day 25±3, and 6 months after the second dose , respectively,and follow up one and half a year |
|
| 1 dose of the third vaccination | Experimental | One dose of COVID-19 vaccine and 1 year of follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccines | Biological | One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of coronavirus vaccine | Rate of adverse effects after COVID-19 vaccination | Within 2 months after the first dose of COVID-19 vaccination |
| Immunogenicity of coronavirus vaccine | Detected the dynamics and titers of anti-SARS-CoV-2 antibodies | Within 2 months after the first dose of COVID-19 vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of coronavirus vaccine | Rate of adverse effects after COVID-19 vaccination | Within 18 months after the first dose of COVID-19 vaccination |
| Immunogenicity of coronavirus vaccine | Detected the dynamics and titers of anti-SARS-CoV-2 antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100039 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33563499 | Result | Cornberg M, Buti M, Eberhardt CS, Grossi PA, Shouval D. EASL position paper on the use of COVID-19 vaccines in patients with chronic liver diseases, hepatobiliary cancer and liver transplant recipients. J Hepatol. 2021 Apr;74(4):944-951. doi: 10.1016/j.jhep.2021.01.032. Epub 2021 Feb 6. | |
| 33577086 | Result | Fix OK, Blumberg EA, Chang KM, Chu J, Chung RT, Goacher EK, Hameed B, Kaul DR, Kulik LM, Kwok RM, McGuire BM, Mulligan DC, Price JC, Reau NS, Reddy KR, Reynolds A, Rosen HR, Russo MW, Schilsky ML, Verna EC, Ward JW, Fontana RJ; AASLD COVID-19 Vaccine Working Group. American Association for the Study of Liver Diseases Expert Panel Consensus Statement: Vaccines to Prevent Coronavirus Disease 2019 Infection in Patients With Liver Disease. Hepatology. 2021 Aug;74(2):1049-1064. doi: 10.1002/hep.31751. |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Within 18 months after the first dose of COVID-19 vaccination |