Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver Diseases

Covid19 Clinical Trial

— SIMPLE  

Official title:

Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver （CQMU）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05007665
• Other study ID #: 2021-48
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2021
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: DACHUAN CAI, PH D
• Phone: 18323409779
• Email: 597521685[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Patients with chronic liver disease diagnosed clinically or pathologically and receiving the whole-course COVID-19 vaccination.

Exclusion Criteria:

1. Patients previously diagnosed or with a history of contact with confirmed cases

2. Patients with contraindications for vaccination.

Related Conditions & MeSH terms

• Adverse Reaction to Vaccine
• Covid19
• Liver Diseases

Intervention

Biological:
• SARS-COV-2 VACCINE
the antibody titer and adverse reactions were observed.

Locations

Country	Name	City	State
China	The second affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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;:. — View Citation

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, — View Citation

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):1200-1 — View Citation

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. Epu — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Titer and duration of COVID-19 antibody production after vaccination	The titer and duration of COVID-19 antibody were produced at 12 weeks	12 weeks after vaccination
Secondary	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
Secondary	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

External Links

•   World Health Organization (WHO) Influenza (Seasonal) 2018 Available from