Rapid T-cell Test to Assess Immune Response in Adults with Chronic HBV and HBV-HDV Infection

What This Trial Is About

Researchers are conducting a prospective, non-pharmacological, single-center observational study to understand the immune response in patients with chronic HBV infection, with or without HBV-HDV co-infection. The study aims to observe the natural history of the infection and treatment effects, correlating immune data with disease outcomes and antiviral therapies. This research is part of an international collaboration between an Italian hospital and Duke-NUS Medical School in Singapore. The study involves groups of patients with chronic HBV or HBV-HDV infections, including those under nucleostide analog treatment, inactive carriers, and patients treated or untreated for HDV infection. The main focus is on applying a rapid T cell assay to measure specific T cell responses. The study includes efforts to improve this assay by simplifying the process and reducing blood sample requirements. Participants will be followed longitudinally for about two years, during which researchers will assess T cell responses and correlate these with clinical profiles, disease severity, and therapy responses. Data will be collected from clinical records and laboratory tests. The primary outcome is the prevalence of specific T cell responses, with secondary outcomes including differences between patient groups and assay optimization. The study does not involve administering drugs or treatments as part of the protocol.

Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease