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

NCT05669677 | Completed

• 2 other identifiers: 10000118000118-DK
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 1

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

Keywords

SARS-CoV-2; Liver Disease; Natural History

Outcome Measures

Primary Outcomes (1)

• Prevalence of SARSCOV-2 in subjects with chronic liver disease

  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

  ongoing

Secondary Outcomes (2)

• To determine the durability of antibody against SARS-COV-2 among patients with chronic liver disease.

  ongoing

• To determine if SARS-COV-2 seropositivity is associated with reactivation or worsening of chronic hepatitis B.

  ongoing

Study Arms (1)

Standard

Chronic liver disease

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• In order to participate in this study, an individual must meet all of the following criteria:
• Male or females \>= 18 years of age
• 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.
• Enrolled in protocol 91-DK-0214 or 18-DK-0091

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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.
• Inability to provide informed consent
• Patients with primary immunodeficiency disorders
• Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Non-alcoholic Fatty Liver Disease; Liver Diseases

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Fatty Liver; Digestive System Diseases

Study Officials

• Marc G Ghany, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 3, 2023
• Study Start: March 15, 2023
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04-15

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)