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

NCT05669677 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 233

Last updated 2026-04-17

No results posted yet for this study

Summary

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 preventing severe symptoms and death from COVID-19. Some people with chronic liver disease, especially those with an advanced condition called cirrhosis, do not respond to many vaccines as well as healthy people do. The goal of this natural history study is to find out how well people with chronic liver disease respond to the COVID-19 vaccines.

Objective:

To learn how chronic liver disease affects the body s immune response to vaccination against COVID-19.

Eligibility:

People aged 18 years or older with chronic liver disease. They must also be enrolled in protocol 91-DK-0214 or 18-DK-0091.

Design:

Participants will have 3 visits, each spaced 6 months apart. Each visit will last 2 hours.

Participants will have their vital signs recorded. These include age, sex, race, height, and weight. They will give their medical history.

At each visit, participants will have blood drawn through a needle inserted into a vein in the arm. The sample drawn at each visit will be from 1 to 8 tablespoons.

At each visit, participants will fill out a questionnaire. They will answer questions about whether they have been vaccinated against COVID-19; whether they have had COVID-19; and whether they have been exposed to someone who had COVID-19. The questionnaire will take 10 to 15 minutes.

Researchers will also look at results of past blood tests from other research studies.

Conditions

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

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Marc G Ghany, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2025-04-04
Completion
2025-04-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05669677 on ClinicalTrials.gov