Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine

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

Timeline

Start

2013-07

Primary completion

2017-10

Completion

2019-05

Drugs

Indications