SIMPLE: Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver Diseases
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Chronic Liver Diseases Patients/Healthy People Chronic hepatitis (B OR C) , autoimmune hepatitis, liver cirrhosis, primary hepatocellular carcinoma |
Biological: SARS-COV-2 VACCINE
the antibody titer and adverse reactions were observed.
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Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events after injection. [4 weeks after vaccination]
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
- Number of participants with adverse events after injection. [12 weeks after vaccination]
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
- Number of participants with adverse events after injection. [24 weeks after vaccination]
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
- Number of participants with adverse events after injection. [48 weeks after vaccination]
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Secondary Outcome Measures
- Titer and duration of COVID-19 antibody production after vaccination [4 weeks after vaccination]
The titer and duration of COVID-19 antibody were produced at 4 weeks
- Titer and duration of COVID-19 antibody production after vaccination [12 weeks after vaccination]
The titer and duration of COVID-19 antibody were produced at 12 weeks
- Titer and duration of COVID-19 antibody production after vaccination [24 weeks after vaccination]
The titer and duration of COVID-19 antibody were produced at 24 weeks
- Titer and duration of COVID-19 antibody production after vaccination [48 weeks 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Patients with chronic liver disease diagnosed clinically or pathologically and receiving the whole-course COVID-19 vaccination.
Exclusion Criteria:
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Patients previously diagnosed or with a history of contact with confirmed cases
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Patients with contraindications for vaccination.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The second affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing | China | 400010 |
Sponsors and Collaborators
- The Second Affiliated Hospital of Chongqing Medical University
Investigators
- Principal Investigator: Hong Ren, PH D, The Second Affiliated Hospital of Chongqing Medical University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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. Erratum in: Lancet. 2020 Jan 30;:.
- 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.
- 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.
- 2021-48