COVID-19 Vaccines in Patients With Chronic Liver Disease

Not Applicable

Recruiting

• Conditions: Liver Disease Chronic
• Interventions: Biological: COVID-19 Vaccines

• Registration Number: NCT05017805
• Lead Sponsor: Beijing 302 Hospital

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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-12
• Study Start: 2021-08-15
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-24
• Last Update Submitted: 2022-04-17
• Last Update Posted: 2022-04-22
• Primary Completion: 2024-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3 doses of vaccine	COVID-19 Vaccines	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
1 dose of the third vaccination	COVID-19 Vaccines	One dose of COVID-19 vaccine and 1 year of follow-up

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Safety of coronavirus vaccine	Within 18 months after the first dose of COVID-19 vaccination	Rate of adverse effects after COVID-19 vaccination

Trial Locations

Locations (1)

The Fifth Medical Center of PLA General Hospital; 🇨🇳 Beijing, Beijing, China