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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Vaccine Reaction; Liver Disease

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China
      • Beijing You'an Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China
      • Chongqing Fuling Central Hospital
  • Fujian
    • Xiamen, Fujian, China
      • The First Affiliated Hospital of Xiamen University
  • Gansu
    • Jinchang, Gansu, China
      • Jinchang Central Hospital
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
    • Qingyang, Gansu, China
      • Qingyang People's Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • The Third Affiliated Hospital of Sun Yat-sen University
  • Hebei
    • Xingtai, Hebei, China
      • Xingtai People's Hospital
  • Heibei
    • Baoding, Heibei, China
      • Baoding People's Hospital
  • Henan
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Jinyintan Hospital
  • Jiangsu
    • Taicang, Jiangsu, China
      • The First People's Hospital of Taicang
    • Wuxi, Jiangsu, China
      • Wuxi Fifth People's Hospital
    • Zhenjiang, Jiangsu, China
      • The Affiliated Third Hospital of Jiangsu University
  • Liaoning
    • Jinzhou, Liaoning, China
      • Jinzhou Central Hospital
    • Shenyang, Liaoning, China
      • Sixth People's Hospital of Shenyang
  • Ningxia Hui Autonomous Region
    • Yinchuan, Ningxia Hui Autonomous Region, China
      • People's Hospital of Ningxia Hui Autonomous Region
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Hospital
    • Qingdao, Shandong, China
      • Qingdao Sixth People's Hospital
    • Yantai, Shandong, China
      • Qishan Hospital of Yantai City
  • Shanghai
    • Shanghai, Shanghai, China
      • Huashan Hospital Affiliated to Fudan University
  • Shanxi
    • Jincheng, Shanxi, China
      • Jincheng People's Hospital
    • Linfen, Shanxi, China
      • The Third People's Hospital of Linfen City
    • Taiyuan, Shanxi, China
      • Shanxi Bethune Hospital
    • Taiyuan, Shanxi, China
      • Taiyuan Third People's Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
    • Yibin, Sichuan, China
      • Yibin First People's Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Second People's Hospital
    • Tianjin, Tianjin, China
      • Tianjin Third Central Hospital
  • Tibet
    • Lasa, Tibet, China
      • The Third People's Hospital of Tibet Autonomous Region
  • Yunnan
    • Kunming, Yunnan, China
      • The First People's Hospital of Yunnan Province
    • Kunming, Yunnan, China
      • Affiliated Hospital of Yunnan University
  • Zhejiang
    • Lishui, Zhejiang, China
      • The Central Hospital of Lishui City
    • Ningbo, Zhejiang, China
      • Beilun Hospital of Traditional Chinese Medicine
    • Yiwu, Zhejiang, China
      • the Fourth Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Populations With Liver Disease who Complete the whole-course COVID-19 vaccination

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events within 7 days after each injection	up to 7 days after each injection

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall incidence of adverse reactions within 28 days as assessed by CTCAE v4.0	up to 28 days after each injection
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
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
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
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

Collaborators and Investigators

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

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Liver Diseases; COVID-19
• Other Study ID Numbers: CHESS2101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No