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Study to Determine the Response to COVID-19 Vaccination and Prevalence of COVID-19 in Subjects With Chronic Liver Disease | Clinical Trials | Clareo Health

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COMPLETEDNCT05669677

Study to Determine the Response to COVID-19 Vaccination and Prevalence of COVID-19 in Subjects With Chronic Liver Disease

Background: The COVID-19 global pandemic killed more than 6 million people worldwide. Several vaccines have been developed against the virus that causes this disease. These vaccines are effective at ...

Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description: The goals of this study are to assess the response to COVID vaccination in patients with chronic liver disease. Secondary goals are to evaluate the durability of antibody response against SARSCOV-2 and if SARS-COV-2 seropositivity is associated with reactivation or worsening of chronic hepatitis B. Hypothesis: Subjects with cirrhosis will have poorer response to COVID vaccination compared to subjects without cirrhosis and to healthy controls. Objectives: Primary Objective To determine the response to SARS-COV-2 vaccination among patients with chronic liver disease stratified by severity (cirrhosis vs no cirrhosis) and compare to healthy controls Secondary Objectives * To determine the durability of antibody against SARS-COV-2 among patients with chronic liver disease * To determine if SARS-COV-2 seropositivity is associated with reactivation or worsening of chronic hepatitis B Tertiary Objective * To determine how SARS-COV-2 affects the pre-existing HBV, HCV, HDV-specific immune response of subjects with liver disease via T cell receptor cross-reactivity or cytokine-mediated bystander cell activation * To determine whether T and B responses to SARS-COV-2 infection or SARS-COV-2 vaccination differ in subjects with and without chronic liver disease and with and without liver cirrhosis. * To determine whether antibody and T and B cell responses against polyethylene glycol (PEG) increase over time and affect the response to the covid vaccine. Endpoints: Primary Endpoints The proportion of patients with \>100 BAU/mL SARS-COV2 antibody levels one year after Covid-19 vaccination Secondary Endpoints * Changes in levels of SARS- COV-2 antibody over time among patients with chronic liver disease stratified by severity (cirrhosis vs no cirrhosis) compared to healthy controls * Assess prevalence of HBV reactivation, defined as reappearance of HBsAg in serum and/or reappearance or increase in HBV DNA by 1 log10 IU/mL in serum in patients with and without prior Covid-19 Tertiary Endpoint * Comparison of HBV, HCV and HDV-specific immune responses before and after SARS-COV-2 infection in patients who experienced SARS-COV-2 between study time points or using as pre-infection time point PBMC stored prior to November 2019 (first global report of SARS-COV-2) * Comparison of T and B responses to SARS-COV-2 infection or SARS-COV-2 vaccines in subjects with and without chronic liver disease and with and without liver cirrhosis, and evaluation of durability of responses in subsequent study visit. * Assessment of anti-PEG IgM and IgG levels and T and B responses against PEG.

Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 16, 2025Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment233

Start dateMar 2023

Last updatedMay 16, 2025

Condition

Chronic or Recovered Hepatitis B Chronic or Recovered Hepatitis C Chronic or Recovered Hepatitis D NAFLD NASH

Locations shown

National Institutes of Health Clinical Center

Bethesda, Maryland

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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