NCT05204602

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

19 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

January 20, 2022

Last Update Submit

February 9, 2022

Conditions

COVID-19Vaccine ReactionLiver Diseases

Keywords

SARS-CoV-2 vaccine boosterliver diseasessafetyimmunogenicity

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Number and rate of abnormal laboratory testing results after the booster vaccination

    Up to 28 days after after booster vaccine injection

  • Concentration and titre of neutralizing antibody after booster vaccination

    Baseline and 14 days, 28 days, 90 days, and 180 days after the booster vaccination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population with liver disease who completed the whole-course COVID-19 vaccination and is going to get booster vaccination.

You may qualify if:

  • Previously vaccinated with two doses of SARS-CoV-2 vaccines and planning to get booster vaccination.
  • Clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver diseases, cirrhosis, liver cancer, liver transplant subjects, etc.
  • Understanding and willing to comply with the study procedures and provides written informed consent.

You may not qualify if:

  • Pregnancy or lactation.
  • Active or known history of SARS-CoV-2 infection.
  • Diseases causing immunosuppressive or immunodeficient status or autoimmune diseases.
  • A history of discontinuing anti-HBV agents in recent three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

RECRUITING

Baoding people's Hospital

Baoding, Hebei, China

NOT YET RECRUITING

Xingtai People's Hospital

Xingtai, Heibei, China

RECRUITING

Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine

Nanjing, Jiangsu, China

NOT YET RECRUITING

The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

NOT YET RECRUITING

Zhenjiang Third Hospital Affiliated to Jiangsu University

Zhenjiang, Jiangsu, China

NOT YET RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

NOT YET RECRUITING

The Sixth Peoples Hospital of Shenyang

Shenyang, Liaoning, China

NOT YET RECRUITING

The Fourth People's Hospital of Qinghai Province

Xining, Qinghai, China

NOT YET RECRUITING

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

NOT YET RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Jincheng People's Hospital

Jincheng, Shanxi, China

NOT YET RECRUITING

The Third People's Hospital of Linfen City

Linfen, Shanxi, China

NOT YET RECRUITING

The Third People's Hospital of Taiyuan

Taiyuan, Shanxi, China

NOT YET RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

NOT YET RECRUITING

The Third Central Hospital of Tianjin

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

The Third People's Hospital of Tibet Autonomous Region

Lhasa, Tibet, China

NOT YET RECRUITING

Lishui People's Hospital

Lishui, Zhejiang, China

NOT YET RECRUITING

Related Publications (13)

  • 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.

    PMID: 32109013BACKGROUND

  • 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.

    PMID: 32623632BACKGROUND

  • 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.

    PMID: 32771429BACKGROUND

  • 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.

    PMID: 32440857BACKGROUND

  • 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.

    PMID: 32446714BACKGROUND

  • 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.

    PMID: 32434831BACKGROUND

  • 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.

    PMID: 32925195BACKGROUND

  • 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.

    PMID: 34942370BACKGROUND

  • 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.

    PMID: 33892006BACKGROUND

  • 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.

    PMID: 33905793BACKGROUND

  • 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.

    PMID: 34815511BACKGROUND

  • 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.

    PMID: 33563499BACKGROUND

  • 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.

    PMID: 34391547BACKGROUND

MeSH Terms

Conditions

COVID-19Liver Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDigestive System Diseases

Central Study Contacts

Jingwen Ai

CONTACT

1376499080jingwenai1990@126.com

Qiran Zhang

CONTACT

+8618817875704qrzhang12@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2022

First Posted

January 24, 2022

Study Start

February 10, 2022

Primary Completion

August 20, 2022

Study Completion

December 20, 2022

Last Updated

February 14, 2022

Record last verified: 2022-02

Locations

CN(19)