Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients

NCT06029634 | Completed

• 1 other identifier: T-bet B
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The immune mechanism of the nucleos(t)ide analogs (NAs) in inhibiting HBV replication effectively while having a low sustained virus control rate after drug withdrawal is unclear. B cell immunity and antibody response are the keys to prevent HBV reinfection and keep the virus under control. T-bet+ B, which can be regulated by IL-21, is a newly discovered major effector B cell in protection of pathogens and it is a main subtype of HBsAg-specific B cells. Thus, we suspect that T-bet+ B may play a role in ongoing controlling of the virus after withdraw of NAs in CHB patient. Based on our previous studies on CHB immunity, we use the RNAseq analyse, flow cytometry, and Elispot assay to analyze the frequency, function, and phenotype of B cells in CHB patients with different profiles after withdraw of NAs.

Conditions

Chronic HBV Infection; Drug Withdrawal

Keywords

transcription factor bet; chronic hepatitis B; nucleotide analogs; function cure; B cell

Outcome Measures

Primary Outcomes (2)

• phenotype of B cells

  CD19+cells were sorted from different samples, the frequency, function, and phenotype of B cells were analyzed.

  PBMC were collected 0、4、12、24 week after withdraw the NAs

• B cell ELISPOT assay

  Sorted B cell subsets were stimulated for 5 days following which B cell ELISPOT was conducted.

  Cells were stimulated with R-848 (1 μg/ml) and IL-2 (10 ng/ml) for 5 days at 37 °C to aid memory B cell differentiation

Study Arms (3)

virologic breakthrough

CHB patients withdraw NAs with virologic breakthrough

Diagnostic Test: T-bet B cell

virologic response

CHB patients withdraw NAs with virologic response

Diagnostic Test: T-bet B cell

healthy group

The healthy (non-HBV infected) group completed a standard HBsAg vaccination scheduled before entering the study

Diagnostic Test: T-bet B cell

Interventions

T-bet B cell DIAGNOSTIC_TEST

The frequency, function, and phenotype of T-bet B cells was tested

healthy group; virologic breakthrough; virologic response

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CHB patients on NAs therapy

You may qualify if:

• to 70 years old, no gender restriction, serum HBsAg positive than 6 months, can understand and sign informed consent, good compliance.

You may not qualify if:

• coinfected with other hepatotropic virus such as hepatitis C virus,hepatitis D -virus,hepatitis E and hepatitis A etc; coinfected with HIV, markers such as ceruloplasmin, anti-nuclear antibodies and anti-mitochondrial antibodies for co-existent autoimmune and metabolic liver diseases were positive, with hepatocellular carcinoma(HCC) with uncontrollable extrehepatic disease, received glucocorticoid or other immune inhibitor therapy, pregnancy

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai hospital

Shanghai, 200433, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

pbmc

MeSH Terms

Conditions

Substance Withdrawal Syndrome; Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xuesong Liang, DR

  Chaihai hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 8, 2023
• Study Start: July 1, 2020
• Primary Completion: August 10, 2023
• Study Completion: August 20, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)