Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000598482
Ethics application status
Approved
Date submitted
14/11/2007
Date registered
21/11/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety study of an improved aluminium-free Hepatitis B vaccine based on a natural plant sugar
Scientific title
A study in healthy adults of a randomised, controlled vaccine intervention study evaluating the safety and immunogenicity of a Hepatitis B vaccine containing Advax adjuvant
Secondary ID [1] 262905 0
HBV001
Universal Trial Number (UTN)
Trial acronym
HBV001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B prevention 2230 0
Condition category
Condition code
Infection 2321 2321 0 0
Other infectious diseases
Public Health 2654 2654 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hepatitis B vaccination comparing three intramuscular immunisations one month apart of hepatitis B surface antigen (HBsAg) 7 micrograms in normal saline with HBsAg 7 micrograms with Advax 5 or 10mg
Intervention code [1] 1939 0
Prevention
Comparator / control treatment
Hepatitis B surface antigen in saline
Control group
Active

Outcomes
Primary outcome [1] 3564 0
Safety assessment including adverse events and local tolerability
Timepoint [1] 3564 0
1 month following final immunisation
Secondary outcome [1] 5367 0
Efficacy of adjuvanted versus control vaccine, as determined by number of subjects achieving HBsAg seroprotection (titre>10 IU/ml)
Efficacy of adjuvanted versus control vaccine, as determined by number of subjects achieving positive T cell proliferative response to HBsAg
Timepoint [1] 5367 0
One month following final immunisation
Secondary outcome [2] 5966 0
T cell responses to HBsAg
Timepoint [2] 5966 0
1 month following final immunisation

Eligibility
Key inclusion criteria
• Age between 18-40
• Healthy male or female
• Non-pregnant
• If child bearing age, using contraception (barrier method, intrauterine device (IUD) or oral contraception)
• No history or evidence of Hep B infection or vaccination
• No history of blood transfusion within last 6 months
• Able to provide written informed consent
• Willing and able to comply with the protocol for the duration of the study.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Serum positive for antibodies to hepatitis B virus (HBV) or for HBV antigens
• History of hepatitis B vaccination
• Previous Hepatitis B infection
• Immunodeficiency
• Diabetes mellitus
• Significant Liver disease (any liver enzyme > 1.5 times upper limit normal)
• Kidney disease (Calculated creatinine clearance female < 60 ml/min, male <60 ml/min).
• Any serious systemic illness last 6 months
• History of vaccine allergy
• Women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, IUD or mechanical barrier device.
• Pregnant or lactating women.
• Concurrent immunosuppressive therapy, including corticosteroids (with the exception of topically applied/inhaled steroids).
• Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment.
• Individuals with a known infection of human immunodeficiency virus (HIV)
• History intravenous drug abuse or alcohol abuse
• Clinically significant abnormal baseline full blood count:
• Any other serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Blinded envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 323 0
5042

Funding & Sponsors
Funding source category [1] 2798 0
Commercial sector/Industry
Name [1] 2798 0
Vaxine Pty Ltd
Country [1] 2798 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vaxine Pty Ltd
Address
Flinders Medical Centre
Adelaide SA 5042
Country
Australia
Secondary sponsor category [1] 2529 0
Hospital
Name [1] 2529 0
Flinders Medical Centre
Address [1] 2529 0
Adelaide SA 5042
Country [1] 2529 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4716 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 4716 0
Flinders Medical Centre
Adelaide SA 5042
Ethics committee country [1] 4716 0
Australia
Date submitted for ethics approval [1] 4716 0
Approval date [1] 4716 0
Ethics approval number [1] 4716 0

Summary
Brief summary
The basic goal for hepatitis B vaccination is to achieve a protective immune response with a minimum of discomfort and without any risk of serious side effects. Current hepatitis B vaccines whilst safe are associated with significant injection site discomfort. In addition they contain aluminium salts which pose uncertain long term risks of toxicity. This study was designed to collect preliminary data on the safety and tolerability of a new hepatitis B vaccine where the aluminium component has been replaced by a natural plant derived sugar which in animal studies has been shown to markedly reduce injection pain while enhancing the protection conferred by the vaccine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27971 0
Address 27971 0
Country 27971 0
Phone 27971 0
Fax 27971 0
Email 27971 0
Contact person for public queries
Name 11128 0
Nikolai Petrovsky
Address 11128 0
Flinders Medical Centre
Adelaide SA 5042
Country 11128 0
Australia
Phone 11128 0
+61 8 82044572
Fax 11128 0
+61 8 82045987
Email 11128 0
[email protected]
Contact person for scientific queries
Name 2056 0
Nikolai Petrovsky
Address 2056 0
Flinders Medical Centre
Adelaide SA 5042
Country 2056 0
Australia
Phone 2056 0
+61 8 82044572
Fax 2056 0
+61 8 82045987
Email 2056 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIImmunogenicity and safety of Advax™, a novel polysaccharide adjuvant based on delta inulin, when formulated with hepatitis B surface antigen: A randomized controlled Phase 1 study2014https://doi.org/10.1016/j.vaccine.2014.09.034
N.B. These documents automatically identified may not have been verified by the study sponsor.