CyTuVax has reported the interim results of a phase I clinical trial assessing the safety and efficacy of its lead product, a Hepatitis B HBAI20 vaccine for non- responders. The interim analysis shows that a combination of CyTuVax’s HBAI20 adjuvant and a standard vaccine induced protective anti-Hepatitis B titres after only 2 vaccinations in 60% of true non-responders. This promising result will be extended in a Phase II study in a larger group of true non-responders. The data of the phase I trial will be published in Q3, 2016.
The Hepatitis B HBAI20 vaccine is intended to fulfill a high unmet medical need among persons requiring protective titres against hepatitis B, such as in a medical profession or for travel purposes. True non-responders have received at least 6 vaccinations with a standard vaccine but failed to build up sufficient immune protection against hepatitis B. The trial is conducted at the Ease Travel Clinic by the Department of Medical Microbiology of the MAASTRICHT UMC and coordinated by Dr. A.M. L. Oude Lashof, MD PhD, Internist and Consultant Infectious Diseases of Maastricht UMC.
The study consists of 3 groups of subjects: 10 true non-responders (no protective anti-Hepatitis B titres after 6 Hepatitis B vaccinations) that were vaccinated with HBAI20 (CyTuVax’s AI20 adjuvant added to HBVaxPro-10 μg), 12 naïve subjects (volunteers who have never received a hepatitis B vaccination before) that were vaccinated with HBAI20 and 12 naïve subjects that were vaccinated with HBVaxPro 10 μg.
Currently, all subjects have been vaccinated twice. In the non-responders group, 60 days after the first vaccination and 30 days after the second vaccination, 60% had protective antibody titres. The adverse events and adverse reactions reported after the first and second vaccination with HBAI20 experimental vaccine were of the number and scale expected for a vaccine and comparable to the HBVaxPro-10μg. There were no serious adverse events reported. The immunogenicity of the HBAI20 is comparable with the immunogenicity of the HBVaxPro-10μg in healthy subjects.
This interim analysis shows that the combined AI20/HBVaxPro vaccination induced protective anti- Hepatitis B titres after 2 vaccinations in 60% of true non-responders. This promising result will be extended in a Phase II study in a larger group of true non-responders and a group of persons with renal deficiency, diabetes and transplant recipients.