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

Phase 1

Completed

• Conditions: Hepatitis B prevention; Infection - Other infectious diseases; Public Health - Epidemiology

• Registration Number: ACTRN12607000598482
• Lead Sponsor: Vaxine Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety assessment including adverse events and local tolerability[1 month following final immunisation]

Secondary Outcome Measures

Name	Time	Method
Efficacy of adjuvanted versus control vaccine, as determined by number of subjects achieving HBsAg seroprotection (titre>10 IU/ml)<br>Efficacy of adjuvanted versus control vaccine, as determined by number of subjects achieving positive T cell proliferative response to HBsAg[One month following final immunisation];T cell responses to HBsAg[1 month following final immunisation]