Chronic or Recovered Hepatitis BNCT05669677
Study to Determine the Response to COVID-19 Vaccination and Prevalence of COVID-19 in Subjects With Chronic Liver Disease
An observational study of Chronic or Recovered Hepatitis B and Chronic or Recovered Hepatitis C, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic or Recovered Hepatitis B, Chronic or Recovered Hepatitis C, Chronic or Recovered Hepatitis D
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 4 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Prospective Cohort 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 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic or Recovered Hepatitis B, Chronic or Recovered Hepatitis C, Chronic or Recovered Hepatitis D, NAFLD, NASH
- Keywords
- SARS-CoV-2, Liver Disease, Natural History
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Chronic liver disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: ongoing
Secondary outcomes (2)
To determine the durability of antibody against SARS-COV-2 among patients with chronic liver disease.
Changes in quantitative levels of SARS-COV-2 antibody over time
Measured: ongoing
To determine if SARS-COV-2 seropositivity is associated with reactivation or worsening of chronic hepatitis B.
Prevalence of HBV re-activation among patients with and without exposure to SARS-COV-2.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start15 Mar 2023
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic or Recovered Hepatitis BStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marc G Ghany, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669677
- Sponsor's protocol ID
- 10000118
- Other IDs
- 000118-DK
- Status last verified
- 15 Apr 2026
- First submitted
- 30 Dec 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since the clinical significance of COVID antibody test results is unclear, we do not plan to inform subjects of these results. Should participants be interested in their current COVID status, we will refer them to testing clinics or to their primary provider for PCR testing.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study to Determine the Response to COVID-19 Vaccination and Prevalence of COVID-19 in Subjects With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT05669677
- Acronym / sponsor ID
- 10000118
- Conditions
- Chronic or Recovered Hepatitis B, Chronic or Recovered Hepatitis C, Chronic or Recovered Hepatitis D, NAFLD, NASH
- Keywords
- SARS-CoV-2, Liver Disease, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard | – | –Chronic liver disease |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- Enrolled in protocol 91-DK-0214 or 18-DK-0091
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of SARSCOV-2 in subjects with chronic liver disease
Time frame: ongoing
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
2 secondary outcomes
To determine the durability of antibody against SARS-COV-2 among patients with chronic liver disease.
Time frame: ongoing
To determine if SARS-COV-2 seropositivity is associated with reactivation or worsening of chronic hepatitis B.
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Since the clinical significance of COVID antibody test results is unclear, we do not plan to inform subjects of these results. Should participants be interested in their current COVID status, we will refer them to testing clinics or to their primary provider for PCR testing.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc G Ghany, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic or Recovered Hepatitis B and Chronic or Recovered Hepatitis C, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of SARSCOV-2 in subjects with chronic liver disease (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.