Clinical trial to evaluate a new Hepatitis B vaccine (CONSTANT study)


What is the purpose of this study?

This study is being performed to compare an “investigational” HBV vaccine against a “standard” HBV vaccine (Engerix-B®) that is already licensed in the United Kingdom (UK), to measure whether it is as good as the currently used vaccine. The study will also compare three lots of the study vaccine (produced at different times), to ensure that the vaccine quality is consistently good. The study vaccine is classed as “investigational” because it is not currently approved for use by the regulatory authorities in the UK, United State (US), Canada or the European Union (EU). However, it has been used in Israel for almost 20 years, and has been approved for use in several other countries to provide protection for infants, children, and adults against hepatitis B disease. Since its original development, the study vaccine has undergone changes in some ingredients used to prepare the study vaccine to make it more effective and safer. Previous studies suggest that the study vaccine has remained an effective vaccine against HBV throughout these changes; however, only a small number of clinical studies have been carried out with the current formulation of the study vaccine. The results of this study will be used to support an application for approval to use the study vaccine in the UK, US, Canada, and Europe.


For further information, please see the Participant Information Sheet: CONSTANT PIS.pdf