COVID-19 Vaccines in Patients With Chronic Liver Disease

April 17, 2022 updated by: Beijing 302 Hospital

Safety and Immunogenicity of COVID-19 Vaccines in Patients With Chronic Liver Disease: A Multi-center Prospective Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Recruiting
        • The Fifth Medical Center of PLA General Hospital
        • Contact:
          • Fu-Sheng Wang, Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3 doses of vaccine
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
Biological: COVID-19 Vaccines
One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.
Experimental: 1 dose of the third vaccination
One dose of COVID-19 vaccine and 1 year of follow-up
Biological: COVID-19 Vaccines
One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of coronavirus vaccine
Time Frame: Within 2 months after the first dose of COVID-19 vaccination
Rate of adverse effects after COVID-19 vaccination
Within 2 months after the first dose of COVID-19 vaccination
Immunogenicity of coronavirus vaccine
Time Frame: Within 2 months after the first dose of COVID-19 vaccination
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
Within 2 months after the first dose of COVID-19 vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of coronavirus vaccine
Time Frame: Within 18 months after the first dose of COVID-19 vaccination
Rate of adverse effects after COVID-19 vaccination
Within 18 months after the first dose of COVID-19 vaccination
Immunogenicity of coronavirus vaccine
Time Frame: Within 18 months after the first dose of COVID-19 vaccination
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
Within 18 months after the first dose of COVID-19 vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing 302 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Anticipated)

August 15, 2024

Study Completion (Anticipated)

August 15, 2025

Study Registration Dates

First Submitted

August 12, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 17, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ky-2021-7-8-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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