Study to Evaluate Immunogenicity and Safety of TVAX-008 Injection in Non/Treated Chronic Hepatitis B Patients With HBsAg≤20IU/ml or HBsAg Negative Without Serological Conversion

Early Phase 1Active Not RecruitingNCT07204236

Grand Theravac Life Sciences (Nanjing) Co., Ltd.20 enrolled

Overview

The objective of this study is to assess the immunogenicity and safety of TVAX-008 injection in antiviral untreated/untreated chronic hepatitis B patients with HBsAg≤20 IU/mL, or HBsAg negative and no seroconversion through an investigator-initiated clinical study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

TVAX-008DRUG

TVAX-008

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female, aged 18-65 years (inclusive); 2. Chronic hepatitis B patients with HBsAg\<20 IU/mL without/on antiviral therapy; or HBsAg negative and no seroconversion population (HBsAg \<20 IU/mL;HBVDNA\<20 IU/mL; ） 3. HBsAg \<10mIU/mL detected at least 4 weeks Exclusion Criteria: 1. Use of immunosuppressants within 6 months prior to first dose: 2. Use of c1orticosteroids (other than topical or inhaled corticosteroids) for 1 week or more within 6 months prior to the first dose; 3. Hepatitis C virus (HCV), hepatitis D virus (HDV), Treponema pallidum (TP) antibody or human immunodeficiency virus (HIV) antibody positive:

Locations (1)

Shandong Province Public Health Clinical Center

Jinan, Shandong, China

Outcomes

Primary Outcomes

Change from baseline in HBSAb levels after end of treatment

Time frame: week24

Data from ClinicalTrials.gov

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