NCT07204236

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2024

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

September 24, 2025

Last Update Submit

September 24, 2025

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HBSAb levels after end of treatment

    Change from baseline in HBSAb levels after end of treatment

    week24

Study Arms (1)

TVAX-008

EXPERIMENTAL

TVAX-008

Drug: TVAX-008

Interventions

TVAX-008DRUG

TVAX-008

TVAX-008

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged 18-65 years (inclusive);
  • 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; ）
  • HBsAg \<10mIU/mL detected at least 4 weeks

You may not qualify if:

  • Use of immunosuppressants within 6 months prior to first dose:
  • Use of c1orticosteroids (other than topical or inhaled corticosteroids) for 1 week or more within 6 months prior to the first dose;
  • Hepatitis C virus (HCV), hepatitis D virus (HDV), Treponema pallidum (TP) antibody or human immunodeficiency virus (HIV) antibody positive:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Province Public Health Clinical Center

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2025

First Posted

October 2, 2025

Study Start

January 18, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)