NCT01951677

Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine

Phase 1 Randomized, Controlled, Double-blind Study to Compare the Safety and Effectiveness of Hepatitis B Vaccines in Individuals With Renal Impairment, Diabetes Mellitus or Age Greater Than 40 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Vaxine Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

Adjuvants are a critical ingredient in most vaccines and act by boosting the immune response to the target protein (e.g. hepatitis B surface antigen (HBsAg)). Despite considerable research, aluminium hydroxide or phosphate compounds (collectively referred to as "alum") remain the dominant adjuvants used in human hepatitis B virus vaccines. There is thus an unmet need for new HBV vaccine adjuvants, in particular, for adjuvants capable of boosting cell-mediated immunity (this is a particular type of immune response where killer T cells are activated that are then able to attack and destroy the infection) as alum, although good at stimulating antibodies is very poor at stimulating cell-mediated immunity. Alum, whilst generally accepted as safe, can be associated with significant local vaccine reactions and this is another reason why newer better-tolerated vaccine adjuvants would be beneficial. This study will compare a range of experimental adjuvant formulations to identify those that provide the safest and most effective enhancement of T- and B-cell immunity against hepatitis B

Conditions

• Exposure to Hepatitis B Virus

Interventions

Type	Name	Description
DRUG	HBsAg	Standard hepatitis B vaccine antigen
BIOLOGICAL	PreS HBsAg	preS hepatitis B surface antigen
BIOLOGICAL	Advax-1(TM)	Adjuvant formulated with vaccine antigen
BIOLOGICAL	Advax-2(TM)	Adjuvant formulated with vaccine antigen
BIOLOGICAL	Advax-3(TM)	Adjuvant formulated with vaccine antigen
BIOLOGICAL	Alum	Adjuvant formulated with vaccine antigen

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-10-01
• Completion: 2019-05-01
• First posted: 2013-09-27
• Last updated: 2019-05-07

Locations

1 site across 1 country: Australia