In a recent press release, CyTuVax B.V. (Maastricht, The Netherlands) unveiled the results of the HBAI20 Phase 2 “BE-Responder” trial. The trial focused on “non-responders” to hepatitis B vaccination—persons who have been vaccinated with at least one complete vaccination course (three injections of a licensed hepatitis B vaccine) without achieving a protective immune response.
In this study, the HBAI20 vaccine can reduce the percentage of non-responders to eight percent compared to 21 percent in the HBVaxPro-10 group (p = .068 Fisher). A statistical evaluation using a generalized linear mixed model demonstrates that subjects who have received the HBAI20 vaccine are 3.5 times more likely to attain seroprotection at the end of the study compared with subjects who received the licensed HBVaxPro-10 vaccine (p < .05).
With the HBAI20 vaccine, seroprotection was achieved earlier than with the HBVAxPro-10 vaccine. Eighty-three percent of the non-responders attained seroprotection after two vaccinations. In contrast, with the licensed HBVaxPro-10 vaccine, after three injections only 79 percent of the non-responders achieved seroprotection.
The safety profile of HBAI20, as compared to HBVaxPro-10, showed a temporary higher number of transient mild and moderate local side effects including: Impaired arm movement, redness, and pain at injection site. This indicates that HBAI20 induces a stronger immune response. No differences regarding systemic side effects were observed in the study.