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Trial record 4 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection (HBV003)

This study is not yet open for participant recruitment.
Verified May 2017 by Vaxine Pty Ltd
Sponsor:
ClinicalTrials.gov Identifier:
NCT03038802
First Posted: February 1, 2017
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Flinders University
Australian Respiratory and Sleep Medicine Institute
Information provided by (Responsible Party):
Vaxine Pty Ltd
  Purpose
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

Condition Intervention Phase
Chronic Hepatitis b Biological: Therapeutic hepatitis B vaccine Biological: Commercial Hepatitis B vaccine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Participants, the investigator and outcomes assessors will be blinded as to which vaccine the subject has received
Primary Purpose: Treatment
Official Title: A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection

Resource links provided by NLM:


Further study details as provided by Vaxine Pty Ltd:

Primary Outcome Measures:
  • Safety assessment: Frequency of vaccine-related adverse events relative to active comparator vaccine [ Time Frame: 12 months post immunisation ]
    Frequency of vaccine-related adverse events relative to active comparator vaccine

  • Viral load [ Time Frame: 1 and 12 months post final immunisation ]
    Suppression of HBV viral load


Secondary Outcome Measures:
  • Seroconversion [ Time Frame: 1 and 12 months post final immunisation ]
    Seroconversion to e antigen (if anti HBe negative at baseline) and seroconversion to surface antigen

  • T-cell response [ Time Frame: 1 and 12 months post final immunisation ]
    Development of memory T-cell responses to HBV

  • B cell response [ Time Frame: 1 and 12 months post final immunisation ]
    Development of memory B-cell responses to HBV


Estimated Enrollment: 40
Anticipated Study Start Date: June 1, 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: Commercial Hepatitis B vaccine
Commercially available prophylactic hepatitis B vaccine formulated with alum adjuvant
Other Name: Engerix B
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.
Biological: Therapeutic hepatitis B vaccine
HBV vaccine based on unique combination of recombinant PreS hepatitis B surface antigen particles formulated with Advax-2 adjuvant
Other Name: Hepadvax(TM)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038802


Contacts
Contact: Kathrina Bartolay, RN 0882044572 kathrina.bartolay@sa.gov.au

Locations
Australia, South Australia
Flinders University Not yet recruiting
Adelaide, South Australia, Australia, 5042
Contact: Kathrina Bartolay, RN    08 8204 7467    kathrina.bartolay@sa.gov.au   
Sub-Investigator: Dimitar Sajkov, MBBS, PhD         
Principal Investigator: David Gordon, MBBS, PhD         
Sub-Investigator: Kate Muller, FRACP         
Sponsors and Collaborators
Vaxine Pty Ltd
Flinders University
Australian Respiratory and Sleep Medicine Institute
Investigators
Principal Investigator: David Gordon, FRACP Flinders University
  More Information

Responsible Party: Vaxine Pty Ltd
ClinicalTrials.gov Identifier: NCT03038802     History of Changes
Other Study ID Numbers: HBV003
First Submitted: January 30, 2017
First Posted: February 1, 2017
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Virus Diseases
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs