COVID-19 vaccination for patients with chronic liver disease
Safety and Immunogenicity of COVID-19 Vaccines in Patients With Chronic Liver Disease: A Multi-center Prospective Study
This study is testing how safe and effective COVID-19 vaccines are for people with chronic liver disease to help protect them from severe illness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing 302 Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05017805 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and immunogenicity of COVID-19 vaccines in patients with chronic liver disease, who are at increased risk for severe outcomes from COVID-19. The study will enroll 300 participants with various liver conditions, including chronic hepatitis and cirrhosis, and will follow them for 18 months post-vaccination. The trial is open-label and aims to gather comprehensive data on the vaccine's effects in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with chronic liver disease who meet specific health criteria.
Not a fit: Patients with liver cancer, severe uncontrolled chronic diseases, or significant vaccine allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and efficacy of COVID-19 vaccines for patients with chronic liver disease.
How similar studies have performed: While there have been numerous studies on COVID-19 vaccines, this specific focus on chronic liver disease patients is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- The Fifth Medical Center of PLA General Hospital — Beijing, Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.