ACTRN12607000598482
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hepatitis B prevention
- Sponsor
- Vaxine Pty Ltd
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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