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On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAï¼²S-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.
Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as autoimmune 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 / influenza vaccine can effectively prevent COVID-19 / influenza virus infection and delay or prevent patients from developing into critical illness and reduce mortality. The safety and effectiveness of COVID-19 / influenza vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively. The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University. Patients with contraindications for vaccination will be excluded. The detected indexes included blood routine test, liver function, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and patients with chronic liver disease before and after vaccination ( 1, 3, 6, 12 months after vaccination). The adverse reactions related to the vaccine were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Liver Diseases Patients/Healthy People | Chronic hepatitis (B OR C) , autoimmune hepatitis, liver cirrhosis, primary hepatocellular carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-COV-2 VACCINE | Biological | the antibody titer and adverse reactions were observed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 4 weeks | 4 weeks after vaccination |
| Titer and duration of COVID-19 antibody production after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic liver disease vaccinated with SARS-Cov-2 vaccine.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DACHUAN CAI, PH D | Contact | 18323409779 | 597521685@qq.com | |
| DAZHI ZHANG, PH D | Contact | 13452382818 | dzhzhang@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Ren, PH D | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31986264 | Background | 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. | |
| 31978945 |
| Label | URL |
|---|---|
| World Health Organization (WHO) Influenza (Seasonal) 2018 Available from | View source |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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The titer and duration of COVID-19 antibody were produced at 12 weeks
| 12 weeks after vaccination |
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 24 weeks | 24 weeks after vaccination |
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 48 weeks after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with chronic liver disease. | 48 weeks after vaccination |
| Background |
| Zhu 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. |
| 32145190 | Background | Zhang 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. |
| 32109013 | Background | 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. |
| 31441906 | Background | Grohskopf 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. |
| 32504052 | Result | Xu 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. |
| 33257893 | Result | Shi 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. |
| 32555424 | Result | Long 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. |
| 32350462 | Result | Long 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. |
| 37457966 | Derived | Zhou 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. |
| 36946505 | Derived | Chen 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. |
| 36705404 | Derived | He 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. |
| 35107848 | Derived | He 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. |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |