Clinical Phase 2 Study - BE RESPONDER!
Hepatitis B HBAI20 vaccine for Non-responders
Cytuvax has completed the Phase 2 BE RESPONDER! clinical study to investigate the immunogenicity and safety of its Hepatitis B HBAI20 vaccine for Non-responders.
The double blinded multi-center international study was conducted at Maastricht University Medical Center, the Ziekenhuis Oost Limburg Genk - Hasselt University and the University of Antwerp under the responsibility of Dr. Astrid Oude Lashof, Dr. Geert Robaeys, and Prof. Pierre van Damme. The study started in February 2017 with the enrolment of the first volunteer. NCT03415672
Worldwide people are suffering from the effects of a hepatitis B virus (HBV) infection. HBV is a virus that can cause acute or chronic liver inflammation, which can lead to liver failure and liver cancer. The disease occurs in particular in Africa, South of the Sahara and in East Asia, where around 10% of the adults are chronic carriers of the virus. About 750,000 people worldwide die annually from the disease.
There are vaccinations available against HBV and these usually provide sufficient protection from HBV after 3 vaccinations. However, there is a small group of people (5% of the population) that does not respond to the standard HBV vaccination, the so-called non-responders.
For these non-responders CyTuVax developed the HBAI20 vaccine. The HBAI20 vaccine consists of a standard HBV vaccine to which the AI20 adjuvant is added. The adjuvant is able to give an additional stimulus to the immune system and may provide sufficient protection against HBV for the non-responders. In addition, the HBAI20 gives a faster protection offering the potential of less vaccinations in the future.