Liver Disease Chronic
Conditions
Keywords
Liver Disease Chronic, COVID-19 vaccination
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.
Interventions
BIOLOGICALCOVID-19 Vaccines
One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.
Sponsors
Beijing 302 Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of coronavirus vaccine | Within 2 months after the first dose of COVID-19 vaccination | Rate of adverse effects after COVID-19 vaccination |
| Immunogenicity of coronavirus vaccine | Within 2 months after the first dose of COVID-19 vaccination | Detected the dynamics and titers of anti-SARS-CoV-2 antibodies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of coronavirus vaccine | Within 18 months after the first dose of COVID-19 vaccination | Rate of adverse effects after COVID-19 vaccination |
| Immunogenicity of coronavirus vaccine | Within 18 months after the first dose of COVID-19 vaccination | Detected the dynamics and titers of anti-SARS-CoV-2 antibodies |
Countries
China
Outcome results
None listed