Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101)

COVID-19 Clinical Trial

Official title:

Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101): a Multicenter Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883177
• Other study ID #: CHESS2101
• Status: Completed
• Start date: May 11, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: April 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver disease are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. Therefore, early inoculation of SARS-CoV-2 vaccine in patients with liver disease is an important protective measure. However, information on the effectiveness and safety of the COVID-19 vaccine for liver disease remains to be determined. This muilticentre study (CHESS2101) aims to study the effectiveness and safety of the COVID-19 vaccination for patients with liver disease.

Description:

Patients with liver disease, especially liver cirrhosis, hepatobiliary malignancies, candidates for liver transplantation, and individuals who are immunosuppressed after liver transplantation, have an increased risk of COVID-19 infection and increased mortality. Therefore, early inoculation of SARS-CoV-2 vaccine in liver disease patients is an important protective measure. A small number of SARS-CoV-2 vaccines have been tested in clinical trials in healthy individuals and have evidence of short-term safety, immunogenicity and efficacy. However, information on the effectiveness and safety of the COVID-19 vaccine for patients with liver disease remains to be determined. This muilticentre study (CHESS2101) aims to study the effectiveness and safety of the COVID-19 vaccination for patients with liver disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinically or pathologically diagnosed with pre-existing liver disease, including:

chronic liver disease, cirrhosis, liver cancer, liver transplant subjects, etc.;

2. Receiving the whole-course COVID-19 vaccination for 14 days or more;

3. Volunteer to participate in this study.

Exclusion Criteria:

1. Younger than 18 years old;

2. Women during pregnancy or lactation;

3. Research on other situations deemed unsuitable for selection.

Related Conditions & MeSH terms

• COVID-19
• Liver Disease
• Liver Diseases
• Vaccine Reaction

Locations

Country	Name	City	State
China	Baoding People's Hospital	Baoding	Heibei
China	Beijing You'an Hospital	Beijing	Beijing
China	Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region	Chengdu	Sichuan
China	Chongqing Fuling Central Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Shandong Provincial Hospital	Jinan	Shandong
China	Jinchang Central Hospital	Jinchang	Gansu
China	Jincheng People's Hospital	Jincheng	Shanxi
China	Jinzhou Central Hospital	Jinzhou	Liaoning
China	Affiliated Hospital of Yunnan University	Kunming	Yunnan
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The Third People's Hospital of Tibet Autonomous Region	Lasa	Tibet
China	The Third People's Hospital of Linfen City	Linfen	Shanxi
China	The Central Hospital of Lishui City	Lishui	Zhejiang
China	Beilun Hospital of Traditional Chinese Medicine	Ningbo	Zhejiang
China	Qingdao Sixth People's Hospital	Qingdao	Shandong
China	Qingyang People's Hospital	Qingyang	Gansu
China	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Sixth People's Hospital of Shenyang	Shenyang	Liaoning
China	The First People's Hospital of Taicang	Taicang	Jiangsu
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Taiyuan Third People's Hospital	Taiyuan	Shanxi
China	Tianjin Second People's Hospital	Tianjin	Tianjin
China	Tianjin Third Central Hospital	Tianjin	Tianjin
China	Wuhan Jinyintan Hospital	Wuhan	Hubei
China	Wuxi Fifth People's Hospital	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Xingtai People's Hospital	Xingtai	Hebei
China	Qishan Hospital of Yantai City	Yantai	Shandong
China	Yibin First People's Hospital	Yibin	Sichuan
China	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia Hui Autonomous Region
China	The Fourth Affiliated Hospital of Zhejiang University	Yiwu	Zhejiang
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The Affiliated Third Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (38)

Lead Sponsor

Collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

Affiliated Hospital of Yunnan University, Baoding People's Hospital, Beijing YouAn Hospital, Beilun Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Chongqing Medical University, Fuling Central Hospital of Chongqing City, Henan Provincial People's Hospital, Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region, Huashan Hospital, Jinchang Central Hospital, Jincheng People's Hospital, Jingzhou Central Hospital, LanZhou University, People's Hospital of Ningxia Hui Autonomous Region, Qingdao Sixth People's Hospital, Qingyang People's Hospital, Qishan Hospital of Yantai City, Shandong Provincial Hospital, Shanxi Bethune Hospital, The Central Hospital of Lishui City, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Xiamen University, The First People's Hospital of Taicang, The First People's Hospital of Yunnan, The Fourth Affiliated Hospital of Zhejiang University, The Sixth People's Hospital of Shenyang City, The Third People's Hospital of Linfen City, The Third People's Hospital of Taiyuan, The Third People's Hospital of Tibet Autonomous Region, The Third People's Hospital of Zhenjiang City, Third Affiliated Hospital, Sun Yat-Sen University, Tianjin Second People's Hospital, Tianjin Third Central Hospital, Wuhan Jinyintan Hospital, Wuxi Fifth People's Hospital, Xingtai City People's Hospital, Yibin First People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Iavarone M, D'Ambrosio R, Soria A, Triolo M, Pugliese N, Del Poggio P, Perricone G, Massironi S, Spinetti A, Buscarini E, Vigano M, Carriero C, Fagiuoli S, Aghemo A, Belli LS, Luca M, Pedaci M, Rimondi A, Rumi MG, Invernizzi P, Bonfanti P, Lampertico P. High rates of 30-day mortality in patients with cirrhosis and COVID-19. J Hepatol. 2020 Nov;73(5):1063-1071. doi: 10.1016/j.jhep.2020.06.001. Epub 2020 Jun 9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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World Health Organization. Coronavirus disease (COVID-2019) situation reports[EB/OL]. https: //www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/.

Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, Li X, Peng C, Zhang Y, Zhang W, Yang Y, Chen W, Gao X, You W, Wang X, Wang Z, Shi Z, Wang Y, Yang X, Zhang L, Huang L, Wang Q, Lu J, Yang Y, Guo J, Zhou W, Wan X, Wu C, Wang W, Huang S, Du J, Meng Z, Pan A, Yuan Z, Shen S, Guo W, Yang X. Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials. JAMA. 2020 Sep 8;324(10):951-960. doi: 10.1001/jama.2020.15543. — View Citation

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* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events within 7 days after each injection		up to 7 days after each injection
Secondary	Overall incidence of adverse reactions within 28 days as assessed by CTCAE v4.0		up to 28 days after each injection
Secondary	Antibody serological conversion rate in populations with liver disease after COVID-19 vaccination		the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination
Secondary	Neutralizing antibody titers in blood samples after vaccination		the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination
Secondary	Antibody IgM titers in blood samples after vaccination		the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination
Secondary	Antibody IgG titers in blood samples after vaccination		the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination