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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07204236

Enrollment

Registered

2025-10-02

Start date

2024-01-18

Completion date

2026-03-01

Last updated

2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief summary

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.

Interventions

DRUGTVAX-008

TVAX-008

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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:

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in HBSAb levels after end of treatment	week24	Change from baseline in HBSAb levels after end of treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026