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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05669677
Recruitment Status : Active, not recruiting
First Posted : January 3, 2023
Last Update Posted : April 9, 2024
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Description
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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.


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

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Study Design
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Study Type : Observational
Actual Enrollment : 216 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study to Determine the Response to COVID-19 Vaccination and Prevalence of COVID-19 in Subjects With Chronic Liver Disease
Actual Study Start Date : March 15, 2023
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Standard
Chronic liver disease


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To determine the durability of antibody against SARS-COV-2 among patients with chronic liver disease. [ Time Frame: ongoing ]
    Changes in quantitative levels of SARS-COV-2 antibody over time

  2. To determine if SARS-COV-2 seropositivity is associated with reactivation or worsening of chronic hepatitis B. [ Time Frame: ongoing ]
    Prevalence of HBV re-activation among patients with and without exposure to SARS-COV-2.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05669677


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Marc G Ghany, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Additional Information:

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT05669677    
Other Study ID Numbers: 10000118
000118-DK
First Posted: January 3, 2023    Key Record Dates
Last Update Posted: April 9, 2024
Last Verified: April 4, 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: .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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
SARS-CoV-2
Liver Disease
Natural History
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis D
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Infections
Virus Diseases
 RNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections