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Citation
Belle, Steven (2024). Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B (HBRN Immunology Treatment) (Version 1) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/tthh-e971
Data Availability Statement
Data from the Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B (HBRN Immunology Treatment) [(Version 1) https://doi.org/10.58020/tthh-e971] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgment Statement
The HBRN Immunology Treatment study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the HBRN Immunology Treatment study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the HBRN Immunology Treatment study and does not necessarily reflect the opinions or views of the HBRN Immunology Treatment study, NIDDK-CR, or NIDDK.
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General Description

Hepatitis B, a significant cause of cirrhosis and hepatocellular carcinoma worldwide, affects an estimated 800,000 to 1.4 million people in the United States. Liver disease pathogenesis and viral clearance in hepatitis B virus (HBV) infection is believed to be immune-mediated, defined by distinct patterns of immune effector and regulatory responses. The Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B study was designed to examine the effects of antiviral therapy in host immune phenotype and to investigate if antiviral immune responses before, during, and after therapy can predict long term therapeutic response. This study is ancillary to two clinical trials conducted by the Hepatitis B Research Network, titled Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B. It is hypothesized that therapeutic HBV suppression will enhance antiviral immune effector responses and reduce immune inhibitory factors in participants with chronic hepatitis B.

Participants for the Immune Regulation and Costimulation study are recruited from individuals who are enrolled in the HBRN clinical trials of adults with chronic hepatitis B. Immune regulatory and effector responses relative to serum HBV DNA, alanine aminotransferase (ALT), and clinical outcome are assessed as primary outcome measures. Specifically, IFN-gamma and IL 10 responses, T cell activation and costimulatory markers (PD1, CTLA4, CD28, CD127), FoxP3+ Treg frequency, dendritic cell frequency, and NK frequency are evaluated as measures of immune response. These measures are evaluated throughout the course of the two clinical trials until the termination of the treatment studies.

Objectives

The study aims to examine the effects of antiviral therapy in host immune phenotype and to investigate if antiviral immune responses before, during, and after therapy can predict long term therapeutic response.

Outcome Measure

Immune regulatory and effector responses relative to serum HBV DNA, alanine aminotransferase (ALT), and clinical outcome are assessed as primary outcome measures. Specifically, IFN-gamma and IL 10 responses, T cell activation and costimulatory markers (PD1, CTLA4, CD28, CD127), FoxP3+ Treg frequency, dendritic cell frequency, and NK frequency are evaluated as measures of immune response. These measures are evaluated throughout the course of the two clinical trials until the termination of the treatment studies.

Eligibility Criteria

Individuals from the HBRN adult clinical trials are enrolled after providing informed consent.

Outcome

This study is ongoing.

Research Area

Liver Disease

Study Type

Observational

Study Sites

21

Study Start Date

2013-03

Study End Date

2024-12

Condition

Hepatitis B Virus Infection

Keywords

Immune Effector Response, HBV DNA, Antiviral Immune Response, Immune Regulatory Response, Chronic Hepatitis B Virus (HBV) Infection, T Cell Activation, Costimulatory Markers, Alanine Aminotransferase (ALT), Ancillary Study

NIDDK Division

DDN

86
Participants

Target Population
Adults
Sex statistics is not available for this study
Age statistics is not available for this study
Race statistics is not available for this study
Ethnicity statistics is not available for this study
Location statistics is not available for this study

Public Documents Table
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Non-Public Documents (7)
Non-Public Documents Table
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Datasets (5)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
ICIT Dataset
Contains data from the Immunology Enrollment Criteria Adult Immune Tolerant Trial (ICIT) formsas7bdat (128 KB); csv (1.58 KB)
ICIA Dataset
Contains data from the Immunology Enrollment Criteria Adult Immune Active Trial (ICIA) formsas7bdat (128 KB); csv (11.55 KB)
IMMUNO TRIALS DS Dataset
Result file from the Immunology Lab containing data from Immune Tolerant and Immune Active immunology samplessas7bdat (768 KB); csv (163.72 KB)
IMMUNO TRIALS RECEIVED Dataset
Log file of samples sent and received at the immunology lab for the Immunology Trial Protocolsas7bdat (128 KB); csv (22.48 KB)
IMMUNO IA DS Dataset
Result file from the Immunology Lab containing data from only Immune Active immunology samplessas7bdat (304 KB); csv (107.29 KB)
Specimens (0)
There are currently no specimens available