Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

There is a need for more effective and better-tolerated hepatitis B vaccines for low responder high-risk populations including patients with renal impairment and/or diabetes mellitus and those aged over 40 years. Several approaches are available to enhance the potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens, replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine antigen. A combination of these strategies is being tested in this study to identify the most promising candidate approaches to take forward into advanced clinical development

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vaxine Pty Ltd
• Collaborator: Flinders Medical Centre
• Treatments: Aluminum Hydroxide; Aluminum sulfate; Vaccines

Criteria

Inclusion Criteria:

• Age 18 years and above

• Male or female

• Able to provide written informed consent

• Willing and able to comply with the protocol for the duration of the study.

• Has one or more of

• Age 40 years or above

• Impaired renal function (creatinine >120 mmol/L or calculated glomerular filtration rate <60mls/min)

• Diagnosis of diabetes mellitus (any type)

Exclusion Criteria:

• History of prior hepatitis B vaccination

• History of serious vaccine allergy if in the opinion of the Investigator this represents a contraindication to hepatitis B vaccination

• Women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device or mechanical barrier device.

• Pregnant or lactating women.

• History of systemic autoimmune disease including Wegener's granulomatosis, systemic lupus erythematosus, Guillain-Barre, scleroderma or multiple sclerosis.

• Participation in another clinical trial with an investigational agent within 28 days of the scheduled date of first immunization.

• Any other serious medical, social or mental condition that, in the opinion of the investigator, would be detrimental to the subjects or the study.