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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03038802
Registration number
NCT03038802
Ethics application status
Date submitted
30/01/2017
Date registered
1/02/2017
Date last updated
9/04/2024
Titles & IDs
Public title
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
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Scientific title
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
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Secondary ID [1]
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HBV003
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Universal Trial Number (UTN)
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Trial acronym
HBV003
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis b
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Therapeutic hepatitis B vaccine
Other interventions - Commercial Hepatitis B vaccine
Active Comparator: Standard vaccine - 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
Experimental: Experimental therapeutic vaccine - 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.
Other interventions: Therapeutic hepatitis B vaccine
HBV vaccine based on unique combination of recombinant PreS hepatitis B surface antigen particles formulated with Advax-2 adjuvant
Other interventions: Commercial Hepatitis B vaccine
Commercially available prophylactic hepatitis B vaccine formulated with alum adjuvant
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety assessment: Frequency of vaccine-related adverse events relative to active comparator vaccine
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Assessment method [1]
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Frequency of vaccine-related adverse events relative to active comparator vaccine
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Timepoint [1]
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12 months post immunisation
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Primary outcome [2]
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Viral load
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Assessment method [2]
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Suppression of HBV viral load
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Timepoint [2]
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1 and 12 months post final immunisation
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Secondary outcome [1]
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Seroconversion
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Assessment method [1]
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Seroconversion to e antigen (if anti HBe negative at baseline) and seroconversion to surface antigen
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Timepoint [1]
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1 and 12 months post final immunisation
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Secondary outcome [2]
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T-cell response
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Assessment method [2]
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Development of memory T-cell responses to HBV
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Timepoint [2]
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1 and 12 months post final immunisation
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Secondary outcome [3]
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B cell response
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Assessment method [3]
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Development of memory B-cell responses to HBV
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Timepoint [3]
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1 and 12 months post final immunisation
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Eligibility
Key inclusion criteria
- 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)
- Able to provide written informed consent
- Willing and able to comply with the protocol for the duration of the study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
30/09/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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ARASMI - Adelaide
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Recruitment postcode(s) [1]
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5046 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Vaxine Pty Ltd
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australian Respiratory and Sleep Medicine Institute
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03038802
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Nikolai Petrovsky, MBBS/PhD
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Address
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Vaxine Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sharen Pringle, RN
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Address
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Country
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Phone
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0437033400
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03038802
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