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Liver disease Patients' vaccine response under the microscope

NCT ID NCT05669677

Knowledge-focused Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how people with chronic liver disease (like hepatitis B, C, or fatty liver) respond to COVID-19 vaccines. About 233 adults had three visits over a year to check their immune response and see if they got COVID-19. The goal was to understand if liver disease affects vaccine protection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

233 people

The number who actually took part.

Started

Mar 2023

Finished

Apr 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Male or female subjects greater than or equal to 18 years of age will be recruited from study 91-DK-0214: with chronic liver disease or recovery of chronic liver disease followed at the Clinical Center.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: In order to participate in this study, an individual must meet all of the following criteria: 1. Male or females \>= 18 years of age 2. Evidence of chronic liver disease within the last 12 months. a. Patients with chronic hepatitis B who became negative for HBsAg will be eligible because they may reactivate following SARS-COV-2 exposure. 3. Enrolled in protocol 91-DK-0214 or 18-DK-0091 EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. History of only resolved chronic Hepatitis C (anti-HCV positive, HCV RNA negative) with no evidence of any other chronic liver disease, unless cirrhotic or unless prior cryopreserved peripheral blood mononuclear cells (PBMC) available. 2. Inability to provide informed consent 3. Patients with primary immunodeficiency disorders 4. Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic hepatitis B virus infection chronic hepatitis C virus infection hepatitis B virus infection hepatitis C virus infection hepatitis D virus infection liver disorder metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic or recovered hepatitis B Chronic or recovered hepatitis C Chronic or recovered hepatitis D NAFLD NASH

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.