Safety and Immunogenicity of COVID-19 Vaccine Booster in Patients With Liver Diseases

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Safety and Immunogenicity of Third Dose SARS-CoV-2 Vaccine Booster in Patients With Liver Diseases Following Two Doses of Inactivated Vaccines (NMCID-CHESS 2201): a Multicenter Cohort Study

ClinicalTrials.gov ID

NCT05204602

Acronym / sponsor ID

NMCIDCHESS2201 / CLD-BOOST

Conditions

COVID-19, Vaccine Reaction, Liver Diseases

Keywords

SARS-CoV-2 vaccine booster, liver diseases, safety, immunogenicity

Study type

Observational

Recruitment status

Unknown status

Enrolment

1,000 participants (estimated)

Lead sponsor

Huashan HospitalUniversity, hospital or other

Collaborators

LanZhou University, Xingtai People's Hospital, The Third Central Hospital of Tianjin, The Third People's Hospital of Taiyuan, Lishui Country People's Hospital, Baoding People's Hospital, The Affiliated Hospital of Qingdao University, Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, The Fifth People's Hospital of Wuxi, Jincheng People's Hospital, Shenyang Sixth People's Hospital, Zhenjiang Third Hospital, The Third People's Hospital of Linfen City, The First Affiliated Hospital of Dalian Medical University, The Fourth People's Hospital of Qinghai Province, The Third People's Hospital of Tibet Autonomous Region, The Second Affiliated Hospital of Chongqing Medical University, Peking University Health Science Center, The Affiliated Hospital Of Southwest Medical University

Study start

10 Feb 2022 (estimated)

Primary completion

20 Aug 2022 (estimated)

Study completion

20 Dec 2022 (estimated)

First posted

24 Jan 2022 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Rate of neutralizing antibody serological conversion after the booster vaccination

   Time frame: Fourteen to 90 days after the booster vaccine

   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.

2. Number and rate of all solicited and non-solicited adverse events

   Time frame: Up to 28 days after booster vaccine injection

   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.

Results and safety

Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
• Background: PubMed 32109013Guan 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.
• Background: PubMed 32623632Sarin 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.
• Background: PubMed 32771429Iavarone 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.
• Background: PubMed 32440857Qi 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.
• Background: PubMed 32446714Moon 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.
• Background: PubMed 32434831Qi 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.
• Background: PubMed 32925195He 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.
• Background: PubMed 34942370Ai 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.
• Background: PubMed 33892006Rabinowich 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.
• Background: PubMed 33905793Wang 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.
• Background: PubMed 34815511Ai 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.
• Background: PubMed 33563499Cornberg 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

19 sites in 1 country: see every site and its status.