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NOT YET RECRUITING
NCT03038802
PHASE1/PHASE2

A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection

Sponsor: Vaxine Pty Ltd

View on ClinicalTrials.gov

Summary

This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV infection. An ongoing human clinical trial of this HBV vaccine in a prophylactic setting has confirmed this vaccine to be more effective at inducing seroconversion as measured by development of Hepatitis B surface antibody (HBsAb) in poor responder subjects than the standard alum-adjuvanted HBV vaccine, providing promise that this new vaccine may also be able to induce HBV viral control and/or seroconversion in chronically infected subjects

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-01

Completion Date

2027-06-30

Last Updated

2025-09-22

Healthy Volunteers

No

Interventions

BIOLOGICAL

Therapeutic hepatitis B vaccine

HBV vaccine based on unique combination of recombinant PreS hepatitis B surface antigen particles formulated with Advax-2 adjuvant

BIOLOGICAL

Commercial Hepatitis B vaccine

Commercially available prophylactic hepatitis B vaccine formulated with alum adjuvant

Locations (1)

ARASMI

Adelaide, South Australia, Australia