Safety study of an improved aluminium-free Hepatitis B vaccine based on a natural plant sugar

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000598482

Acronym

HBV001

Enrollment

Registered

2007-11-21

Start date

2006-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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collect preliminary data on the safety and tolerability of a new hepatitis B vaccine where the aluminium component has been replaced by a natural plant derived sugar which in animal studies has been shown to markedly reduce injection pain while enhancing the protection conferred by the vaccine.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

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.

Outcome results