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

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04883177
• Collaborator: LanZhou University (Other), Huashan Hospital (Other), The Sixth People's Hospital of Shenyang City (Other), Xingtai City People's Hospital (Other), Jinchang Central Hospital (Other), Baoding People's Hospital (Other), The Third People's Hospital of Zhenjiang City (Other), Shanxi Bethune hospital, Shanxi, China (Other), Wuhan Jinyintan Hospital (Other), Jincheng People's Hospital (Other), The Third People's Hospital of Tibet Autonomous Region (Other), People's Hospital of Ningxia Hui Autonomous Region (Other), Fuling Central Hospital of Chongqing City (Other), Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region (Other), The Central Hospital of Lishui City (Other), The Third People's Hospital of Linfen City (Other), Yibin First People's Hospital (Other), Jingzhou Central Hospital (Other), Wuxi Fifth People's Hospital (Other), Qingyang People's Hospital (Other), The First Affiliated Hospital of Anhui Medical University (Other), Beilun Hospital of Traditional Chinese Medicine (Other), Henan Provincial People's Hospital (Other), Qingdao Sixth People's Hospital (Other), The First Affiliated Hospital of Xiamen University (Other), Shandong Provincial Hospital (Other), Beijing YouAn Hospital (Other), The First People's Hospital of Taicang (Other), Taiyuan Third People's Hospital (Other), Tianjin Second People's Hospital (Other), Tianjin Third Central Hospital (Other), Qishan Hospital of Yantai City (Other), Affiliated Hospital of Yunnan University (Other), The First People's Hospital of Yunnan (Other), The Fourth Affiliated Hospital of Zhejiang University (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other), First Affiliated Hospital of Chongqing Medical University (Other)
• Enrollment: 1,000
• Locations: 37
• Anticipated Duration (Months): 24
• Patients Per Site: 27
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Liver Disease; Vaccine Reaction

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101): a Multicenter Cohort Study
• Actual Study Start Date: May 11, 2021
• Anticipated Primary Completion Date: May 10, 2023
• Anticipated Study Completion Date: May 10, 2023

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events within 7 days after each injection [up to 7 days after each injection]

Secondary Outcome Measures

1. Overall incidence of adverse reactions within 28 days as assessed by CTCAE v4.0 [up to 28 days after each injection]

2. 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]

3. 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]

4. 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]

5. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China
2	Beijing You'an Hospital	Beijing	Beijing	China
3	Chongqing Fuling Central Hospital	Chongqing	Chongqing	China
4	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China
5	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China
6	Jinchang Central Hospital	Jinchang	Gansu	China
7	The First Hospital of Lanzhou University	Lanzhou	Gansu	China	730000
8	Qingyang People's Hospital	Qingyang	Gansu	China
9	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China
10	Xingtai People's Hospital	Xingtai	Hebei	China
11	Baoding People's Hospital	Baoding	Heibei	China
12	Henan Provincial People's Hospital	Zhengzhou	Henan	China
13	Wuhan Jinyintan Hospital	Wuhan	Hubei	China
14	The First People's Hospital of Taicang	Taicang	Jiangsu	China
15	Wuxi Fifth People's Hospital	Wuxi	Jiangsu	China
16	The Affiliated Third Hospital of Jiangsu University	Zhenjiang	Jiangsu	China
17	Jinzhou Central Hospital	Jinzhou	Liaoning	China
18	Sixth People's Hospital of Shenyang	Shenyang	Liaoning	China
19	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia Hui Autonomous Region	China
20	Shandong Provincial Hospital	Jinan	Shandong	China
21	Qingdao Sixth People's Hospital	Qingdao	Shandong	China
22	Qishan Hospital of Yantai City	Yantai	Shandong	China
23	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai	China
24	Jincheng People's Hospital	Jincheng	Shanxi	China
25	The Third People's Hospital of Linfen City	Linfen	Shanxi	China
26	Shanxi Bethune Hospital	Taiyuan	Shanxi	China
27	Taiyuan Third People's Hospital	Taiyuan	Shanxi	China
28	Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region	Chengdu	Sichuan	China
29	Yibin First People's Hospital	Yibin	Sichuan	China
30	Tianjin Second People's Hospital	Tianjin	Tianjin	China
31	Tianjin Third Central Hospital	Tianjin	Tianjin	China
32	The Third People's Hospital of Tibet Autonomous Region	Lasa	Tibet	China
33	Affiliated Hospital of Yunnan University	Kunming	Yunnan	China
34	The First People's Hospital of Yunnan Province	Kunming	Yunnan	China
35	The Central Hospital of Lishui City	Lishui	Zhejiang	China
36	Beilun Hospital of Traditional Chinese Medicine	Ningbo	Zhejiang	China
37	The Fourth Affiliated Hospital of Zhejiang University	Yiwu	Zhejiang	China

Sponsors and Collaborators

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

Investigators

• Study Chair: Xiaolong Qi, MD, LanZhou University
• Study Chair: Wenhong Zhang, MD, Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.
• 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.
• 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.
• Iavarone M, D'Ambrosio R, Soria A, Triolo M, Pugliese N, Del Poggio P, Perricone G, Massironi S, Spinetti A, Buscarini E, Viganò M, Carriero C, Fagiuoli S, Aghemo A, Belli LS, Lucà 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.
• Moon AM, Webb GJ, Aloman C, Armstrong MJ, Cargill T, Dhanasekaran R, Genescà 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.
• 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.
• 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.
• 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.
• 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.
• Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17.

• Responsible Party: Xiaolong Qi, Chief, CHESS Center, Institute of Portal Hypertension, Hepatopancreatobiliary Surgery Institute of Gansu Province
• ClinicalTrials.gov Identifier: NCT04883177
• Other Study ID Numbers: CHESS2101
• First Posted: May 12, 2021
• Last Update Posted: May 12, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Liver Diseases

Study Results

No Results Posted as of May 12, 2021