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| Name | Class |
|---|---|
| LanZhou University | OTHER |
| Xingtai People's Hospital | OTHER |
| The Third Central Hospital of Tianjin | UNKNOWN |
| The Third People's Hospital of Taiyuan |
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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
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 28 days after booster vaccine injection |
| Measure | Description | Time Frame |
|---|---|---|
| Number and rate of abnormal laboratory testing results after the booster vaccination | Abnormal laboratory testing results will be record and grade for severity. | Up to 28 days after after booster vaccine injection |
| Concentration and titre of neutralizing antibody after booster vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Population with liver disease who completed the whole-course COVID-19 vaccination and is going to get booster vaccination.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingwen Ai | Contact | 1376499080 | jingwenai1990@126.com | |
| Qiran Zhang | Contact | +8618817875704 | qrzhang12@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32109013 | Background | Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28. | |
| 32623632 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| OTHER |
| Lishui Country People's Hospital | OTHER |
| Baoding People's Hospital | UNKNOWN |
| The Affiliated Hospital of Qingdao University | OTHER |
| Affiliated Hospital of Nanjing University of Chinese Medicine | OTHER |
| The Fifth People's Hospital of Wuxi | UNKNOWN |
| Jincheng People's Hospital | OTHER |
| Shenyang Sixth People's Hospital | OTHER |
| Zhenjiang Third Hospital | UNKNOWN |
| The Third People's Hospital of Linfen City | UNKNOWN |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| The Fourth People's Hospital of Qinghai Province | OTHER |
| The Third People's Hospital of Tibet Autonomous Region | UNKNOWN |
| The Second Affiliated Hospital of Chongqing Medical University | OTHER |
| Peking University Health Science Center | OTHER |
| The Affiliated Hospital Of Southwest Medical University | OTHER |
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The results will be generated from competitive binding immuoenzymatic capture chemiluminescence immunoassays |
| Baseline and 14 days, 28 days, 90 days, and 180 days after the booster vaccination |
| The First Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | 730000 | China |
|
| Baoding people's Hospital | Not yet recruiting | Baoding | Hebei | China |
|
| Xingtai People's Hospital | Recruiting | Xingtai | Heibei | China |
|
| Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine | Not yet recruiting | Nanjing | Jiangsu | China |
|
| The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University | Not yet recruiting | Wuxi | Jiangsu | China |
|
| Zhenjiang Third Hospital Affiliated to Jiangsu University | Not yet recruiting | Zhenjiang | Jiangsu | China |
|
| The First Affiliated Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | China |
|
| The Sixth Peoples Hospital of Shenyang | Not yet recruiting | Shenyang | Liaoning | China |
|
| The Fourth People's Hospital of Qinghai Province | Not yet recruiting | Xining | Qinghai | China |
|
| the Affiliated Hospital of Qingdao University | Not yet recruiting | Qingdao | Shandong | China |
|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
|
| Jincheng People's Hospital | Not yet recruiting | Jincheng | Shanxi | China |
|
| The Third People's Hospital of Linfen City | Not yet recruiting | Linfen | Shanxi | China |
|
| The Third People's Hospital of Taiyuan | Not yet recruiting | Taiyuan | Shanxi | China |
|
| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | China |
|
| The Third Central Hospital of Tianjin | Not yet recruiting | Tianjin | Tianjin Municipality | China |
|
| The Third People's Hospital of Tibet Autonomous Region | Not yet recruiting | Lhasa | Tibet | China |
|
| Lishui People's Hospital | Not yet recruiting | Lishui | Zhejiang | China |
|
| Background |
| Sarin SK, Choudhury A, Lau GK, Zheng MH, Ji D, Abd-Elsalam S, Hwang J, Qi X, Cua IH, Suh JI, Park JG, Putcharoen O, Kaewdech A, Piratvisuth T, Treeprasertsuk S, Park S, Wejnaruemarn S, Payawal DA, Baatarkhuu O, Ahn SH, Yeo CD, Alonzo UR, Chinbayar T, Loho IM, Yokosuka O, Jafri W, Tan S, Soo LI, Tanwandee T, Gani R, Anand L, Esmail ES, Khalaf M, Alam S, Lin CY, Chuang WL, Soin AS, Garg HK, Kalista K, Batsukh B, Purnomo HD, Dara VP, Rathi P, Al Mahtab M, Shukla A, Sharma MK, Omata M; APASL COVID Task Force, APASL COVID Liver Injury Spectrum Study (APCOLIS Study-NCT 04345640). Pre-existing liver disease is associated with poor outcome in patients with SARS CoV2 infection; The APCOLIS Study (APASL COVID-19 Liver Injury Spectrum Study). Hepatol Int. 2020 Sep;14(5):690-700. doi: 10.1007/s12072-020-10072-8. Epub 2020 Jul 4. |
| 32771429 | Background | Iavarone M, D'Ambrosio R, Lampertico P; CirCoV study group. Reply to: Correspondence on "High rates of 30-day mortality in patients with cirrhosis and COVID-19". J Hepatol. 2020 Dec;73(6):1570-1571. doi: 10.1016/j.jhep.2020.08.001. Epub 2020 Aug 7. No abstract available. |
| 32440857 | Background | Qi X, Wang J, Li X, Wang Z, Liu Y, Yang H, Li X, Shi J, Xiang H, Liu T, Kawada N, Maruyama H, Jiang Z, Wang F, Takehara T, Rockey DC, Sarin SK; COVID-Cirrhosis-CHESS Group. Clinical course of COVID-19 in patients with pre-existing decompensated cirrhosis: initial report from China. Hepatol Int. 2020 Jul;14(4):478-482. doi: 10.1007/s12072-020-10051-z. Epub 2020 May 22. |
| 32446714 | Background | Moon AM, Webb GJ, Aloman C, Armstrong MJ, Cargill T, Dhanasekaran R, Genesca J, Gill US, James TW, Jones PD, Marshall A, Mells G, Perumalswami PV, Qi X, Su F, Ufere NN, Barnes E, Barritt AS, Marjot T. High mortality rates for SARS-CoV-2 infection in patients with pre-existing chronic liver disease and cirrhosis: Preliminary results from an international registry. J Hepatol. 2020 Sep;73(3):705-708. doi: 10.1016/j.jhep.2020.05.013. Epub 2020 May 21. No abstract available. |
| 32434831 | Background | Qi X, Liu Y, Wang J, Fallowfield JA, Wang J, Li X, Shi J, Pan H, Zou S, Zhang H, Chen Z, Li F, Luo Y, Mei M, Liu H, Wang Z, Li J, Yang H, Xiang H, Li X, Liu T, Zheng MH, Liu C, Huang Y, Xu D, Li X, Kang N, He Q, Gu Y, Zhang G, Shao C, Liu D, Zhang L, Li X, Kawada N, Jiang Z, Wang F, Xiong B, Takehara T, Rockey DC; COVID-Cirrhosis-CHESS Group. Clinical course and risk factors for mortality of COVID-19 patients with pre-existing cirrhosis: a multicentre cohort study. Gut. 2021 Feb;70(2):433-436. doi: 10.1136/gutjnl-2020-321666. Epub 2020 May 20. No abstract available. |
| 32925195 | Background | He Q, Zhang G, Gu Y, Wang J, Tang Q, Jiang Z, Shao C, Zhang H, Chen Z, Ma B, Liu D, Xie G, Xu D, Huang Y, Zhang H, Liang M, Huang H, Wang Y, Liu H, Yang J, Pan H, Zou S, Li F, Wang F, Liu C, Wang W, Xiong B, Li X, Liu L, Yang J, Qi X. Clinical Characteristics of COVID-19 Patients With Pre-existing Hepatitis B Virus Infection: A Multicenter Report. Am J Gastroenterol. 2021 Feb 1;116(2):420-421. doi: 10.14309/ajg.0000000000000924. No abstract available. |
| 34942370 | Background | Ai J, Wang J, Liu D, Xiang H, Guo Y, Lv J, Zhang Q, Li J, Zhang X, Li Q, Liang J, Guo X, Feng Y, Liu L, Zhang X, Qin W, Wang X, Rao W, Zhang Q, Tian Q, Zhang Y, Xie F, Jiang S, Yan Y, Qiu Y, Wu H, Hou Z, Zhang N, Zhang A, Ji J, Yang J, Huang J, Zhao Z, Gu Y, Bian L, Zhang Z, Zou S, Ji H, Ge G, Du X, Hou A, Zhu Y, Cong Q, Xu J, Zu H, Wang Y, Yan Z, Yan X, BianBa Y, Ci Q, Zhang L, Yang S, Gao X, Zhong L, He S, Liu C, Huang Y, Liu Y, Xu D, Zhu Q, Xu X, Lv M, Zhang W, Qi X. Safety and Immunogenicity of SARS-CoV-2 Vaccines in Patients With Chronic Liver Diseases (CHESS-NMCID 2101): A Multicenter Study. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1516-1524.e2. doi: 10.1016/j.cgh.2021.12.022. Epub 2021 Dec 20. |
| 33892006 | Background | Rabinowich L, Grupper A, Baruch R, Ben-Yehoyada M, Halperin T, Turner D, Katchman E, Levi S, Houri I, Lubezky N, Shibolet O, Katchman H. Low immunogenicity to SARS-CoV-2 vaccination among liver transplant recipients. J Hepatol. 2021 Aug;75(2):435-438. doi: 10.1016/j.jhep.2021.04.020. Epub 2021 Apr 21. |
| 33905793 | Background | Wang J, Hou Z, Liu J, Gu Y, Wu Y, Chen Z, Ji J, Diao S, Qiu Y, Zou S, Zhang A, Zhang N, Wang F, Li X, Wang Y, Liu X, Lv C, Chen S, Liu D, Ji X, Liu C, Ren T, Sun J, Zhao Z, Wu F, Li F, Wang R, Yan Y, Zhang S, Ge G, Shao J, Yang S, Liu C, Huang Y, Xu D, Li X, Ai J, He Q, Zheng MH, Zhang L, Xie Q, Rockey DC, Fallowfield JA, Zhang W, Qi X. Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study. J Hepatol. 2021 Aug;75(2):439-441. doi: 10.1016/j.jhep.2021.04.026. Epub 2021 Apr 24. |
| 34815511 | Background | Ai J, Zhang H, Zhang Q, Zhang Y, Lin K, Fu Z, Song J, Zhao Y, Fan M, Wang H, Qiu C, Zhou Y, Zhang W. Recombinant protein subunit vaccine booster following two-dose inactivated vaccines dramatically enhanced anti-RBD responses and neutralizing titers against SARS-CoV-2 and Variants of Concern. Cell Res. 2022 Jan;32(1):103-106. doi: 10.1038/s41422-021-00590-x. Epub 2021 Nov 23. No abstract available. |
| 33563499 | Background | 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. |
| 34391547 | Background | Hillus D, Schwarz T, Tober-Lau P, Vanshylla K, Hastor H, Thibeault C, Jentzsch S, Helbig ET, Lippert LJ, Tscheak P, Schmidt ML, Riege J, Solarek A, von Kalle C, Dang-Heine C, Gruell H, Kopankiewicz P, Suttorp N, Drosten C, Bias H, Seybold J; EICOV/COVIM Study Group; Klein F, Kurth F, Corman VM, Sander LE. Safety, reactogenicity, and immunogenicity of homologous and heterologous prime-boost immunisation with ChAdOx1 nCoV-19 and BNT162b2: a prospective cohort study. Lancet Respir Med. 2021 Nov;9(11):1255-1265. doi: 10.1016/S2213-2600(21)00357-X. Epub 2021 Aug 13. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004066 | Digestive System Diseases |