COVID-19 Vaccines in Patients With Chronic Liver Disease

Liver Disease Chronic Clinical Trial

Official title:

Safety and Immunogenicity of COVID-19 Vaccines in Patients With Chronic Liver Disease: A Multi-center Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05017805
• Other study ID #: ky-2021-7-8-1
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: August 15, 2025

Study information

• Verified date: August 2021
• Source: Beijing 302 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.

Description:

This study is a prospective, open-label clinical trial. A total of 300 patients with different cancers including chronic hepatitis, cirrhosis .All of the patients will further accept 18 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 15, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Serum ALT and AST are both = 80 U/L.

• HIV and TPHA screening were negative.

• Body temperature =37.0?.

Exclusion Criteria:

• Patients who confirmed the diagnosis of liver cancer by imaging examination (CT/MRI/B scan).

• Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.

• Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months.

• Patients with cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.

• Patients with severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / neuroedema.c.

• Patients with urticaria within a year.

• Patients with coagulation disorder.

• Faintng during acupuncture treatment .

• Patients who received other investigational drugs within one month.

• Be receiving anti-TB treatment.

• Other conditions determined by the researcher.

Related Conditions & MeSH terms

• COVID-19
• Liver Disease Chronic
• Liver Diseases

Intervention

Biological:
• COVID-19 Vaccines
One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.

Locations

Country	Name	City	State
China	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Cornberg M, Buti M, Eberhardt CS, Grossi PA, Shouval D. EASL position paper on the use of COVID-19 vaccines in patients with chronic liver diseases, hepatobiliary cancer and liver transplant recipients. J Hepatol. 2021 Apr;74(4):944-951. doi: 10.1016/j.jh — View Citation

Fix OK, Blumberg EA, Chang KM, Chu J, Chung RT, Goacher EK, Hameed B, Kaul DR, Kulik LM, Kwok RM, McGuire BM, Mulligan DC, Price JC, Reau NS, Reddy KR, Reynolds A, Rosen HR, Russo MW, Schilsky ML, Verna EC, Ward JW, Fontana RJ; AASLD COVID-19 Vaccine Work — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of coronavirus vaccine	Rate of adverse effects after COVID-19 vaccination	Within 2 months after the first dose of COVID-19 vaccination
Primary	Immunogenicity of coronavirus vaccine	Detected the dynamics and titers of anti-SARS-CoV-2 antibodies	Within 2 months after the first dose of COVID-19 vaccination
Secondary	Safety of coronavirus vaccine	Rate of adverse effects after COVID-19 vaccination	Within 18 months after the first dose of COVID-19 vaccination
Secondary	Immunogenicity of coronavirus vaccine	Detected the dynamics and titers of anti-SARS-CoV-2 antibodies	Within 18 months after the first dose of COVID-19 vaccination