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HBAI20 is an investigational hepatitis B vaccine developed by CyTuVax BV, specifically designed for individuals who fail to achieve protective antibody levels after standard vaccination (non-responders). It is a combination product consisting of the licensed recombinant hepatitis B vaccine HBVaxPro (containing 10 µg of HBsAg) and a proprietary adjuvant called AI20. The AI20 adjuvant is composed of 20 µg of recombinant human interleukin-2 (IL-2) aggregates adsorbed to 20 µg of aluminium hydroxide. This formulation acts as a depot at the injection site, allowing for the slow release of highly concentrated IL-2 aggregates, which enhances the immune response to the hepatitis B surface antigen. HBAI20 has completed Phase 2 clinical testing (the BE-Responder trial), demonstrating significantly improved seroconversion rates in previous non-responders compared to standard vaccination.
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