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A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
Sponsor: Vaxine Pty Ltd
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
Conditions
Interventions
Therapeutic hepatitis B vaccine
HBV vaccine based on unique combination of recombinant PreS hepatitis B surface antigen particles formulated with Advax-2 adjuvant
Commercial Hepatitis B vaccine
Commercially available prophylactic hepatitis B vaccine formulated with alum adjuvant
Locations (1)
ARASMI
Adelaide, South Australia, Australia