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

Completed

• Conditions: Chronic HBV Infection; Drug Withdrawal
• Interventions: Diagnostic Test: T-bet B cell

• Registration Number: NCT06029634
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2023-08
• Primary Completion: 2023-08-10
• Study Completion: 2023-08-20
• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Study First Posted: 2023-09-08
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
virologic response	T-bet B cell	CHB patients withdraw NAs with virologic response
healthy group	T-bet B cell	The healthy (non-HBV infected) group completed a standard HBsAg vaccination scheduled before entering the study
virologic breakthrough	T-bet B cell	CHB patients withdraw NAs with virologic breakthrough

Primary Outcome Measures

Name	Time	Method
B cell ELISPOT assay	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	Sorted B cell subsets were stimulated for 5 days following which B cell ELISPOT was conducted.
phenotype of B cells	PBMC were collected 0、4、12、24 week after withdraw the NAs	CD19+cells were sorted from different samples, the frequency, function, and phenotype of B cells were analyzed.

Trial Locations

Locations (1)

Changhai hospital; 🇨🇳 Shanghai, China