ANZCTR - Registration

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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]

HBV001

Universal Trial Number (UTN)

Trial acronym

HBV001

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hepatitis B prevention

Condition category

Condition code

Infection

Other infectious diseases

Public Health

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]

Prevention

Comparator / control treatment

Hepatitis B surface antigen in saline

Control group

Active

Outcomes

Primary outcome [1]

Safety assessment including adverse events and local tolerability

Timepoint [1]

1 month following final immunisation

Secondary outcome [1]

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]

One month following final immunisation

Secondary outcome [2]

T cell responses to HBsAg

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5042

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Vaxine Pty Ltd

Address [1]

Flinders Medical Centre
Adelaide SA 5042

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Vaxine Pty Ltd

Address

Flinders Medical Centre
Adelaide SA 5042

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Flinders Medical Centre

Address [1]

Adelaide SA 5042

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Flinders Clinical Research Ethics Committee

Ethics committee address [1]

Flinders Medical Centre
Adelaide SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Nikolai Petrovsky

Address

Flinders Medical Centre
Adelaide SA 5042

Country

Australia

Phone

+61 8 82044572

Fax

+61 8 82045987

[email protected]

Contact person for scientific queries

Name

Nikolai Petrovsky

Address

Flinders Medical Centre
Adelaide SA 5042

Country

Australia

Phone

+61 8 82044572

Fax

+61 8 82045987

[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

Source	Title	Year of Publication	DOI
Dimensions AI	Immunogenicity and safety of Advax™, a novel polysaccharide adjuvant based on delta inulin, when formulated with hepatitis B surface antigen: A randomized controlled Phase 1 study	2014	https://doi.org/10.1016/j.vaccine.2014.09.034

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically