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

COVID-19 Clinical Trial

— NMCIDCHESS2201  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05204602
• Other study ID #: CLD-BOOST
• Status: Recruiting
• Start date: February 10, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: February 2022
• Source: Huashan Hospital
• Contact: Jingwen Ai
• Phone: 1376499080
• Email: jingwenai1990[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 20, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19
• Liver Diseases
• Vaccine Reaction

Locations

Country	Name	City	State
China	Baoding people's Hospital	Baoding	Hebei
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Jincheng People's Hospital	Jincheng	Shanxi
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The Third People's Hospital of Tibet Autonomous Region	Lhasa	Tibet
China	The Third People's Hospital of Linfen City	Linfen	Shanxi
China	Lishui People's Hospital	Lishui	Zhejiang
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine	Nanjing	Jiangsu
China	the Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Huashan Hospital	Shanghai	Shanghai
China	The Sixth Peoples Hospital of Shenyang	Shenyang	Liaoning
China	The Third People's Hospital of Taiyuan	Taiyuan	Shanxi
China	The Third Central Hospital of Tianjin	Tianjin	Tianjin
China	The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu
China	Xingtai People's Hospital	Xingtai	Heibei
China	The Fourth People's Hospital of Qinghai Province	Xining	Qinghai
China	Zhenjiang Third Hospital Affiliated to Jiangsu University	Zhenjiang	Jiangsu

Sponsors (20)

Lead Sponsor

Collaborator

Huashan Hospital

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

Country where clinical trial is conducted

China, 

References & Publications (13)

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. 2021 Dec 20. pii: S1542-3565(21)01346-X. doi: 10.1016/j.cgh.2021.12.022. [Epub ahead of print] — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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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. — 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. — View Citation

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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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number and rate of abnormal laboratory testing results after the booster vaccination	Abnormal laboratory testing results will be record and grade for severity.	Up to 28 days after after booster vaccine injection
Secondary	Concentration and titre of neutralizing antibody after booster vaccination	The results will be generated from competitive binding immuoenzymatic capture chemiluminescence immunoassays	Baseline and 14 days, 28 days, 90 days, and 180 days after the booster vaccination