Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver Diseases
SIMPLE
1 other identifier
observational
2,000
1 country
1
Brief Summary
On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as immune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), those patients has a higher risk of infection than the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. To evaluate the safety and effectiveness of COVID-19 vaccine in those patients with chronic liver diseases, and to guide the COVID-19 vaccination more scientifically, reasonably and effectively, this study was carried out.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 9, 2021
CompletedFirst Posted
Study publicly available on registry
August 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedAugust 16, 2021
August 1, 2021
2 years
August 9, 2021
August 12, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Number of participants with adverse events after injection.
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
4 weeks after vaccination
Number of participants with adverse events after injection.
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
12 weeks after vaccination
Number of participants with adverse events after injection.
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
24 weeks after vaccination
Number of participants with adverse events after injection.
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
48 weeks after vaccination
Secondary Outcomes (4)
Titer and duration of COVID-19 antibody production after vaccination
4 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
12 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
24 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
48 weeks after vaccination
Study Arms (1)
Chronic Liver Diseases Patients/Healthy People
Chronic hepatitis (B OR C) , autoimmune hepatitis, liver cirrhosis, primary hepatocellular carcinoma
Interventions
the antibody titer and adverse reactions were observed.
Eligibility Criteria
Patients with chronic liver disease vaccinated with SARS-Cov-2 vaccine.
You may qualify if:
- Healthy group were as follows: no history of hepatitis, no history of liver cirrhosis, no history of liver cancer and receiving the whole-course COVID-19 vaccination.
- Patients with chronic liver disease diagnosed clinically or pathologically and receiving the whole-course COVID-19 vaccination.
You may not qualify if:
- Patients previously diagnosed or with a history of contact with confirmed cases
- Patients with contraindications for vaccination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The second affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Related Publications (13)
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PMID: 31986264BACKGROUNDZhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PMID: 31978945BACKGROUNDZhang C, Shi L, Wang FS. Liver injury in COVID-19: management and challenges. Lancet Gastroenterol Hepatol. 2020 May;5(5):428-430. doi: 10.1016/S2468-1253(20)30057-1. Epub 2020 Mar 4. No abstract available.
PMID: 32145190BACKGROUNDGuan 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: 32109013BACKGROUNDGrohskopf LA, Alyanak E, Broder KR, Walter EB, Fry AM, Jernigan DB. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 Influenza Season. MMWR Recomm Rep. 2019 Aug 23;68(3):1-21. doi: 10.15585/mmwr.rr6803a1.
PMID: 31441906BACKGROUNDXu X, Sun J, Nie S, Li H, Kong Y, Liang M, Hou J, Huang X, Li D, Ma T, Peng J, Gao S, Shao Y, Zhu H, Lau JY, Wang G, Xie C, Jiang L, Huang A, Yang Z, Zhang K, Hou FF. Seroprevalence of immunoglobulin M and G antibodies against SARS-CoV-2 in China. Nat Med. 2020 Aug;26(8):1193-1195. doi: 10.1038/s41591-020-0949-6. Epub 2020 Jun 5.
PMID: 32504052RESULTShi Q, Hu Y, Peng B, Tang XJ, Wang W, Su K, Luo C, Wu B, Zhang F, Zhang Y, Anderson B, Zhong XN, Qiu JF, Yang CY, Huang AL. Effective control of SARS-CoV-2 transmission in Wanzhou, China. Nat Med. 2021 Jan;27(1):86-93. doi: 10.1038/s41591-020-01178-5. Epub 2020 Nov 30.
PMID: 33257893RESULTLong QX, Tang XJ, Shi QL, Li Q, Deng HJ, Yuan J, Hu JL, Xu W, Zhang Y, Lv FJ, Su K, Zhang F, Gong J, Wu B, Liu XM, Li JJ, Qiu JF, Chen J, Huang AL. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med. 2020 Aug;26(8):1200-1204. doi: 10.1038/s41591-020-0965-6. Epub 2020 Jun 18.
PMID: 32555424RESULTLong QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ, Hu Y, Ren JH, Tang N, Xu YY, Yu LH, Mo Z, Gong F, Zhang XL, Tian WG, Hu L, Zhang XX, Xiang JL, Du HX, Liu HW, Lang CH, Luo XH, Wu SB, Cui XP, Zhou Z, Zhu MM, Wang J, Xue CJ, Li XF, Wang L, Li ZJ, Wang K, Niu CC, Yang QJ, Tang XJ, Zhang Y, Liu XM, Li JJ, Zhang DC, Zhang F, Liu P, Yuan J, Li Q, Hu JL, Chen J, Huang AL. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun;26(6):845-848. doi: 10.1038/s41591-020-0897-1. Epub 2020 Apr 29.
PMID: 32350462RESULTZhou Y, Chen Z, He Y, Peng X, Chang Y, Tan A, Li H, Cai D, Hu P, Chen M, Peng M, Xu H, Ren H. Humoral immune responses to inactivated COVID-19 vaccine up to 1 year in children with chronic hepatitis B infection. Front Cell Infect Microbiol. 2023 Jun 29;13:1201101. doi: 10.3389/fcimb.2023.1201101. eCollection 2023.
PMID: 37457966DERIVEDChen Z, Huang T, He T, Zha G, Zhu Q, Zhang G, Xiang D, Chen M, Li H, Ling N, Lan Y, Shi X, Zhang D, Xu P, Pan Q, Song R, Cao J, Zhang Y, Xiang H, Feng Y, Yang Z, Zhang B, Shen W, Cai D, Peng M, Hu P, Ren H. Humoral responses after primary and booster SARS-CoV-2 inactivated vaccination in patients with chronic hepatitis B virus infection: A longitudinal observational study. J Med Virol. 2023 Apr;95(4):e28695. doi: 10.1002/jmv.28695.
PMID: 36946505DERIVEDHe T, Ling N, Zhang G, Xiang D, Hu P, Peng M, Cai D, Zhang D, Chen M, Ren H. Decreased antibody response to influenza vaccine with an enhanced antibody response to subsequent SARS-CoV-2 vaccination in patients with chronic hepatitis B virus infection. Immun Inflamm Dis. 2023 Jan;11(1):e759. doi: 10.1002/iid3.759.
PMID: 36705404DERIVEDHe T, Zhou Y, Xu P, Ling N, Chen M, Huang T, Zhang B, Yang Z, Ao L, Li H, Chen Z, Zhang D, Shi X, Lei Y, Wang Z, Zeng W, Hu P, Lan Y, Zhou Z, Kang J, Huang Y, Shi T, Pan Q, Zhu Q, Ran X, Zhang Y, Song R, Xiang D, Xiao S, Zhang G, Shen W, Peng M, Cai D, Ren H. Safety and antibody response to inactivated COVID-19 vaccine in patients with chronic hepatitis B virus infection. Liver Int. 2022 Jun;42(6):1287-1296. doi: 10.1111/liv.15173. Epub 2022 Feb 28.
PMID: 35107848DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Ren, PH D
The Second Affiliated Hospital of Chongqing Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2021
First Posted
August 16, 2021
Study Start
July 1, 2021
Primary Completion
June 30, 2023
Study Completion
December 30, 2023
Last Updated
August 16, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share