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

NCT03038802 | Not Yet Recruiting Phase 1

• 1 other identifier: HBV003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (2)

• Safety assessment: Frequency of vaccine-related adverse events relative to active comparator vaccine

  Frequency of vaccine-related adverse events relative to active comparator vaccine

  12 months post immunisation

• Viral load

  Suppression of HBV viral load

  1 and 12 months post final immunisation

Secondary Outcomes (3)

• Seroconversion

  1 and 12 months post final immunisation

• T-cell response

  1 and 12 months post final immunisation

• B cell response

  1 and 12 months post final immunisation

Study Arms (2)

Standard vaccine

ACTIVE COMPARATOR

Subjects will receive regular intramuscular injections of a commercial hepatitis B vaccine (HBsAg containing aluminium hydroxide adjuvant) according to the same study schedule as the subjects in the experimental arm

Biological: Commercial Hepatitis B vaccine

Experimental therapeutic vaccine

EXPERIMENTAL

Subjects will receive regular intramuscular injections of the experimental therapeutic hepatitis B vaccine (preS HBsAg containing Advax-2 adjuvant) in two cycles with the first cycle of four immunisations administered on days 0, 14, 28, 42. and the second cycle of four immunisations on days 70, 84, 98, and 112.

Biological: Therapeutic hepatitis B vaccine

Interventions

Therapeutic hepatitis B vaccine BIOLOGICAL

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

Also known as: Hepadvax(TM)

Experimental therapeutic vaccine

Commercial Hepatitis B vaccine BIOLOGICAL

Commercially available prophylactic hepatitis B vaccine formulated with alum adjuvant

Also known as: Engerix B

Standard vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• years of age or older
• Current evidence of HBV chronic infection (with or without cirrhosis) as indicated by detection of HBsAg and/or Hepatitis B DNA (Subjects on current nucleoside therapy may have no detectable Hep B DNA)
• If child bearing age, using contraception (barrier method, IUD or oral contraception)
• Able to provide written informed consent
• Willing and able to comply with the protocol for the duration of the study.

You may not qualify if:

• Positive for antibody to hepatitis B core antigen (anti-HBc) IgM with negative results for the rest of the HBV markers, indicating acute infection,
• Positive for anti-delta virus, or anti-hepatitis C virus or HIV
• Childs Pugh Score for Cirrhosis Mortality of Child grade B or greater
• Liver transaminases greater than 5 times the upper limit of normal
• History of severe allergic reaction to hepatitis B vaccine.
• Pregnancy or female of child-bearing age not using effective method of contraception.
• Presence of any other organ-specific disease that in the opinion of the investigator may result in risk to the subject from involvement in the study
• Current alcohol or drug abuse that in the opinion of the investigator may result in non-compliance.
• Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment

Sponsors & Collaborators

• Vaxine Pty Ltd: lead
• Australian Respiratory and Sleep Medicine Institute: collaborator

Study Sites (1)

ARASMI

Adelaide, South Australia, 5046, Australia

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Engerix-B

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nikolai Petrovsky, MBBS/PhD

  Vaxine Pty Ltd

  STUDY DIRECTOR

Central Study Contacts

Sharen Pringle, RN

CONTACT

0437033400; admin@arasmi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, the investigator and outcomes assessors will be blinded as to which vaccine the subject has received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 1, 2017
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

AU (1)