This is a multicenter, open-label, non-randomized, Phase 1 clinical study with single-dose and multiple-dose dose-escalation cohorts. The study is designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of TVAX-028 in patients with chronic hepatitis B virus infection
1. Subjects voluntarily sign the informed consent, fully understand the study content, and are willing and able to comply with all trial procedures.
2. Male or female, aged 18 to 65 years.
3. Has a clinical diagnosis of chronic hepatitis B virus infection based on protocol-defined criteria.
4. Is receiving stable antiviral treatment with a single nucleos(t)ide analogue before enrollment. Has adequately suppressed HBV DNA and acceptable liver function based on protocol-defined criteria before the first administration of adjuvant or TVAX-028.
1. Has liver disease other than chronic hepatitis B virus infection that may interfere with study participation or interpretation of study results
2. Has evidence or suspected evidence of hepatocellular carcinoma, cirrhosis, clinically significant hepatic space-occupying lesions, or clinically significant liver fibrosis based on imaging, laboratory testing, or non-invasive liver assessment.
3. Has clinically significant abnormalities in laboratory tests, including but not limited to liver function, renal function, hematology, coagulation, or electrolyte parameters, based on protocol-defined criteria.
4. Has received interferon or pegylated interferon treatment within the protocol-defined period before the first administration of adjuvant or TVAX-028, or plans to receive such treatment during the study.