Clinical trial NCT05017805: COVID-19 Vaccines in Patients With Chronic Liver Disease
Official title: Safety and Immunogenicity of COVID-19 Vaccines in Patients With Chronic Liver Disease: A Multi-center Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Disease Chronic
Keywords: Liver Disease Chronic
COVID-19 vaccination
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of coronavirus vaccine
timeFrame: Within 2 months after the first dose of COVID-19 vaccination
measure: Immunogenicity of coronavirus vaccine
timeFrame: Within 2 months after the first dose of COVID-19 vaccination
Secondary outcomes:
measure: Safety of coronavirus vaccine
timeFrame: Within 18 months after the first dose of COVID-19 vaccination
measure: Immunogenicity of coronavirus vaccine
timeFrame: Within 18 months after the first dose of COVID-19 vaccination
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital
state: Beijing
Study officials:
References:
citation: 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.jhep.2021.01.032. Epub 2021 Feb 6.
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 Working Group. American Association for the Study of Liver Diseases Expert Panel Consensus Statement: Vaccines to Prevent Coronavirus Disease 2019 Infection in Patients With Liver Disease. Hepatology. 2021 Aug;74(2):1049-1064. doi: 10.1002/hep.31751.