NCT05017805

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

August 15, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

April 22, 2022

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

August 12, 2021

Last Update Submit

April 17, 2022

Conditions

Liver Disease Chronic

Keywords

Liver Disease ChronicCOVID-19 vaccination

Outcome Measures

Primary Outcomes (2)

  • Safety of coronavirus vaccine

    Rate of adverse effects after COVID-19 vaccination

    Within 2 months after the first dose of COVID-19 vaccination

  • Immunogenicity of coronavirus vaccine

    Detected the dynamics and titers of anti-SARS-CoV-2 antibodies

    Within 2 months after the first dose of COVID-19 vaccination

Secondary Outcomes (2)

  • Safety of coronavirus vaccine

    Within 18 months after the first dose of COVID-19 vaccination

  • Immunogenicity of coronavirus vaccine

    Within 18 months after the first dose of COVID-19 vaccination

Study Arms (2)

3 doses of vaccine

EXPERIMENTAL

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

1 dose of the third vaccination

EXPERIMENTAL

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

Biological: COVID-19 Vaccines

Interventions

COVID-19 VaccinesBIOLOGICAL

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

1 dose of the third vaccination3 doses of vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Serum ALT and AST are both ≤ 80 U/L.
  • HIV and TPHA screening were negative.
  • Body temperature ≤37.0℃.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

Related Publications (2)

  • Cornberg M, Buti M, Eberhardt CS, Grossi PA, Shouval D. EASL position paper on the use of COVID-19 vaccines in patients with chronic liver diseases, hepatobiliary cancer and liver transplant recipients. J Hepatol. 2021 Apr;74(4):944-951. doi: 10.1016/j.jhep.2021.01.032. Epub 2021 Feb 6.

    PMID: 33563499RESULT

  • Fix OK, Blumberg EA, Chang KM, Chu J, Chung RT, Goacher EK, Hameed B, Kaul DR, Kulik LM, Kwok RM, McGuire BM, Mulligan DC, Price JC, Reau NS, Reddy KR, Reynolds A, Rosen HR, Russo MW, Schilsky ML, Verna EC, Ward JW, Fontana RJ; AASLD COVID-19 Vaccine Working Group. American Association for the Study of Liver Diseases Expert Panel Consensus Statement: Vaccines to Prevent Coronavirus Disease 2019 Infection in Patients With Liver Disease. Hepatology. 2021 Aug;74(2):1049-1064. doi: 10.1002/hep.31751.

    PMID: 33577086RESULT

MeSH Terms

Interventions

COVID-19 Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2021

First Posted

August 24, 2021

Study Start

August 15, 2021

Primary Completion

August 15, 2024

Study Completion

August 15, 2025

Last Updated

April 22, 2022

Record last verified: 2021-08

Locations

CN(1)