Back to resultsCOVID-19 Vaccines in Patients With Chronic Liver Disease
Primary Purpose
Liver Disease Chronic
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
COVID-19 Vaccines
Sponsored by
About this trial
This is an interventional treatment trial for Liver Disease Chronic focused on measuring Liver Disease Chronic, COVID-19 vaccination
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.
Sites / Locations
- The Fifth Medical Center of PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
3 doses of vaccine
1 dose of the third vaccination
Arm Description
Covid-19 vaccination on day 0, day 25±3, and 6 months after the second dose , respectively，and follow up one and half a year
One dose of COVID-19 vaccine and 1 year of follow-up
Outcomes
Primary Outcome Measures
Safety of coronavirus vaccine
Rate of adverse effects after COVID-19 vaccination
Immunogenicity of coronavirus vaccine
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
Secondary Outcome Measures
Safety of coronavirus vaccine
Rate of adverse effects after COVID-19 vaccination
Immunogenicity of coronavirus vaccine
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05017805
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
August 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing 302 Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease Chronic
Keywords
Liver Disease Chronic, COVID-19 vaccination
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3 doses of vaccine
Arm Type
Experimental
Arm Description
Covid-19 vaccination on day 0, day 25±3, and 6 months after the second dose , respectively，and follow up one and half a year
Arm Title
1 dose of the third vaccination
Arm Type
Experimental
Arm Description
One dose of COVID-19 vaccine and 1 year of follow-up
Intervention Type
Biological
Intervention Name(s)
COVID-19 Vaccines
Intervention Description
One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.
Primary Outcome Measure Information:
Title
Safety of coronavirus vaccine
Description
Rate of adverse effects after COVID-19 vaccination
Time Frame
Within 2 months after the first dose of COVID-19 vaccination
Title
Immunogenicity of coronavirus vaccine
Description
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
Time Frame
Within 2 months after the first dose of COVID-19 vaccination
Secondary Outcome Measure Information:
Title
Safety of coronavirus vaccine
Description
Rate of adverse effects after COVID-19 vaccination
Time Frame
Within 18 months after the first dose of COVID-19 vaccination
Title
Immunogenicity of coronavirus vaccine
Description
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
Time Frame
Within 18 months after the first dose of COVID-19 vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Fifth Medical Center of PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fu-Sheng Wang, MD
Phone
01066933328
Email
fswang302@163.com
First Name & Middle Initial & Last Name & Degree
Fu-Sheng Wang, Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
33563499
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.
Results Reference
result
PubMed Identifier
33577086
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.
Results Reference
result
Learn more about this trial
COVID-19 Vaccines in Patients With Chronic Liver Disease
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