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12-10-2018

 

Inclusion completed for Phase II clinical trial - “BE-Responder”

Press release

12-10-2018

CyTuVax B.V. from Maastricht announced today that the last subject has been included in its Phase II trial “BE-Responder”. This trial focuses on so-called non-responders to hepatitis B vaccination, these are persons who have been vaccinated with at least 3 licensed hepatitis B vaccines, but never achieved a protective immune response. In the “BE-Responder” study subjects were either vaccinated with HBAI20, a combination of HBVaxPro10® (MSD) plus CyTuVax’s AI20 adjuvant or with the licensed vaccine HBVaxPro10® only. For more information on the clinical trial see www.clinicaltrials.gov study number NCT03415672.

After the promising results of the Phase I trial with 90% of the non-responders developing protective antibody titers with the new HBAI20 vaccine, a more extensive Phase II trial has been initiated. Under the leadership of dr. A.M.L. Oude Lashof (MUMC+) over 130 subjects have been included in the three participating centers in the Netherlands and Belgium since March 1017:

- Maastricht (MUMC+ – Maastricht University Medical Center)

- Antwerpen (University of Antwerp - VAXINFECTIO)

- Genk (ZOL/UH – Ziekenhuis Oost-Limburg/University Hasselt)

The applied AI20 adjuvant in Phase II study contains depot-formulated cytokine aggregates. It is able to activate the immune system in an unprecedented manner as has been shown in the Phase I trial. The final vaccination of the last enrolled subject in the Phase II trial is anticipated by end of November. CyTuVax anticipates to publish the results in the first quarter of 2019.