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.
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.
Biological: COVID-19 Vaccines
One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.
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.
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing, China
Investigator: Fu-Sheng Wang, MD
Contact: 01066933328
fswang302@163.com