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

ConditionChronic Hepatitis b
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVaxine Pty Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female

18 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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Therapeutic hepatitis B vaccine

    Biological/Vaccine

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

  • Commercial Hepatitis B vaccine

    Biological/Vaccine

    Commercially available prophylactic hepatitis B vaccine formulated with alum adjuvant

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Standard vaccineActive comparator 1 intervention
Group B: Experimental therapeutic vaccineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
12 months post immunisation
2

Viral load

Suppression of HBV viral load

Time frame
1 and 12 months post final immunisation

Secondary outcomes

1

Seroconversion

Seroconversion to e antigen (if anti HBe negative at baseline) and seroconversion to surface antigen

Time frame
1 and 12 months post final immunisation
2

T-cell response

Development of memory T-cell responses to HBV

Time frame
1 and 12 months post final immunisation
3

B cell response

Development of memory B-cell responses to HBV

Time frame
1 and 12 months post final immunisation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vaxine Pty Ltd

Lead sponsor

Australian Respiratory and Sleep Medicine Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: