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

Vaxine Pty Ltd0 个研究点目标入组 24 人开始时间: 2007年11月21日最近更新: 2020年1月13日

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•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.

•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.

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