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HBAI20 is an investigational adjuvanted hepatitis B vaccine developed by CyTuVax BV. It is designed to induce seroprotection in individuals who do not respond adequately to standard recombinant hepatitis B vaccines (non-responders). The vaccine is a combination of a novel adjuvant called AI20—which comprises 20 µg of recombinant human interleukin-2 (IL-2) attached to 20 µg of aluminium hydroxide—and the licensed recombinant hepatitis B vaccine HBVaxPro-10 µg. The AI20 adjuvant acts as a depot-attached cytokine system, facilitating the slow release of highly concentrated IL-2 nano-aggregates to enhance the immune response to the hepatitis B surface antigen (HBsAg). HBAI20 has been evaluated in Phase 1 and Phase 2 clinical trials in the Netherlands and Belgium, demonstrating improved immunogenicity and a higher rate of seroprotection in documented prior vaccine non-responders.
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