Germinal center immune response in chronic hepatitis B
Official title: The Role and Regulatory Mechanism of Germinal Center Immune Response in Hepatitis B Virus Infection
Run by Nanfang Hospital, Southern Medical University · NCT07240350 · Data updated 2026-11-12
We will see if the structure and B-cell activity in germinal centers differ between people with chronic hepatitis B and people without by analyzing blood and discarded surgical tissues.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 280 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | January 1, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | February 12, 2027 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07240350 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with chronic hepatitis B or HBsAg-negative patients who are scheduled for liver, spleen, tonsil, or lymph node surgery and who meet the inclusion criteria are ideal candidates.
✕Probably not a fit
People who are not undergoing relevant surgery or who have excluded co-infections or immune/serious underlying conditions are unlikely to receive direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective cross-sectional study will enroll about 280 participants undergoing clinically indicated liver, spleen, tonsil, or lymph node surgery. Investigators will collect discarded tissues and peripheral blood to compare the phenotype, function, and clonal complexity of B cells and other immune cells in germinal centers from chronic HBV-infected and HBsAg-negative patients. The project will map HBV antigen specificity of B cell clones and examine structural, transcriptomic, and proteomic differences in germinal center tissues. No protocol-driven treatments will be given and patient care decisions remain with treating physicians.
Why it matters
Potential benefit: If successful, the findings could clarify how chronic HBV alters germinal center immunity and help guide future vaccines or immune-based therapies.
How similar studies have gone: Previous work has reported altered germinal center responses in chronic viral infections, but applying detailed phenotypic, single-cell, transcriptomic, and proteomic analyses specifically to HBV germinal centers is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Before performing any research-related steps, the patient understood the research process, signed the informed consent, and complied with the research requirements. 3. Patients diagnosed with chronic hepatitis B virus infection according to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B(2019 Version)" . Exclusion Criteria: 1. Those concomitant HCV, HIV infection, alcoholic fatty liver disease, non-alcoholic fatty liver disease, and autoimmune liver disease , etc. were excluded. 2. Diseases of the immune system or coagulation system, such as hyperthyroidism, diabetes, thrombocytopenic purpura, etc., were excluded. 3. Exclude serious underlying diseases that affect the immune status of the body. 4. The investigator believes that there are other circumstances that are not suitable for inclusion.
Where it's running
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Nanfang hospital, Southern Medical university
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Yongyin Li
- Email: yongyinli@foxmail.com
- Phone: +8613826039505
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.