COVID-19 Vaccines in Patients With Chronic Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2025-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Immunogenicity of COVID-19 Vaccine Booster in Patients With Liver Diseases

NCT05204602

COVID-19 Vaccine Reaction Liver Diseases

UNKNOWN

Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver Diseases

NCT05007665

Liver Diseases Covid19 Adverse Reaction to Vaccine

UNKNOWN

Antibody Response to COVID-19 Vaccines in Liver Disease Patients

NCT04775069

Chronic Liver Disease

COMPLETED PHASE4

A Study to Evaluate Vaccines Against COVID-19 in the Real World

NCT04775056

Chronic Liver Disease Hepatic Carcinoma

WITHDRAWN

Robust Antibody and Cytokine Response to Hepatitis B Vaccine Among Not-in-treatment Patients With Chronic Hepatitis C：An Open-label Control Study in China

NCT02898922

Hepatitis B Vaccines

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Disease Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

COVID-19 Vaccines

Intervention Type BIOLOGICAL

One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.

1 dose of the third vaccination

One dose of COVID-19 vaccine and 1 year of follow-up

Group Type EXPERIMENTAL

COVID-19 Vaccines

Intervention Type BIOLOGICAL

One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COVID-19 Vaccines

One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No