The Role and Regulatory Mechanism of Germinal Center Immune Response in Hepatitis B Virus Infection

NCT07240350 | Recruiting DMC

• 1 other identifier: NFEC-2022-279
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to investigate the structure and composition of germinal centers in individuals with chronic HBV infection. The primary questions it aims to address are: What are the phenotypes, functions, and complexity of B cell clones of the immune cells within the germinal centers of chronic HBV-infected individuals? Do chronic HBV-infected individuals have ectopic germinal centers in the liver? This will be studied by collecting peripheral blood and discarded liver, lymph node, and tonsil tissues from chronic HBV patients undergoing lymph node surgery, hepatectomy, and tonsillectomy.

Conditions

Hepatitis B Virus Infection

Keywords

Germinal center; humoral immunity; immune response; hepatitis B virus infection

Outcome Measures

Primary Outcomes (1)

• The HBV-specific immune response levels will be measured using the immune cells from lymphoid follicle of the enrolled patients

  Tissue section from the enrolled patients will be used to detect the levels of HBV-specific immunity and other laboratory indicators after restimulation with HBV peptide pools.

  After the tissue section collected

Secondary Outcomes (1)

• Germinal center organization transcriptomics will be measured using the tissue section of the enrolled patients

  After the tissue section collected

Study Arms (2)

HBV patients who underwent liver, spleen, tonsil, and lymph node surgery

The group of HBV patients who underwent liver, spleen, tonsil, and lymph node surgery.

Procedure: Tissue resection

Healthy patients who underwent liver, spleen, tonsil, and lymph node surgery

The group of HBV patients who underwent liver, spleen, tonsil, and lymph node surgery.

Procedure: Tissue resection

Interventions

Tissue resection PROCEDURE

The group of HBV patients who underwent liver, spleen, tonsil, and lymph node surgery and the group of HBV-negative patients who underwent liver, spleen, tonsil, and lymph node surgery

HBV patients who underwent liver, spleen, tonsil, and lymph node surgery; Healthy patients who underwent liver, spleen, tonsil, and lymph node surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The group of HBV patients who underwent liver, spleen, tonsil, and lymph node surgery and the group of HBV-negative patients who underwent liver, spleen, tonsil, and lymph node surgery

You may qualify if:

• Male or female, patients with chronic hepatitis B and hepatitis B surface antigen negative patients with clinical diagnosis who need to undergo liver, spleen, tonsil or lymph node surgery.
• Before performing any research-related steps, the patient understood the research process, signed the informed consent, and complied with the research requirements.
• Patients diagnosed with chronic hepatitis B virus infection according to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B(2019 Version)" .

You may not qualify if:

• Those concomitant HCV, HIV infection, alcoholic fatty liver disease, non-alcoholic fatty liver disease, and autoimmune liver disease , etc. were excluded.
• Diseases of the immune system or coagulation system, such as hyperthyroidism, diabetes, thrombocytopenic purpura, etc., were excluded.
• Exclude serious underlying diseases that affect the immune status of the body.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang hospital, Southern Medical university

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Yongyin Li

CONTACT

+8613826039505; yongyinli@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: November 20, 2025
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 12, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)