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Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine

NCT01951677 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2019-05-07

No results posted yet for this study

Summary

There is a need for more effective and better-tolerated hepatitis B vaccines for low responder high-risk populations including patients with renal impairment and/or diabetes mellitus and those aged over 40 years. Several approaches are available to enhance the potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens, replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine antigen. A combination of these strategies is being tested in this study to identify the most promising candidate approaches to take forward into advanced clinical development

Conditions

  • Exposure to Hepatitis B Virus

Interventions

DRUG

HBsAg

Standard hepatitis B vaccine antigen

BIOLOGICAL

PreS HBsAg

preS hepatitis B surface antigen

BIOLOGICAL

Advax-1(TM)

Adjuvant formulated with vaccine antigen

BIOLOGICAL

Advax-2(TM)

Adjuvant formulated with vaccine antigen

BIOLOGICAL

Advax-3(TM)

Adjuvant formulated with vaccine antigen

BIOLOGICAL

Alum

Adjuvant formulated with vaccine antigen

Sponsors & Collaborators

  • Flinders Medical Centre

    collaborator OTHER_GOV

  • Vaxine Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Jeffrey Barbara, MBBS PhD · Flinders Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-10-31
Completion
2019-05-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01951677 on ClinicalTrials.gov