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Recombinant hepatitis B surface antigen (HBsAg) is a protein biologic that serves as a key component of the TherVacB therapeutic vaccine regimen. Developed by Helmholtz Munich and the Technical University of Munich, it is produced as virus-like particles (VLPs) using recombinant DNA technology. In the TherVacB protocol, it is formulated with Th1-inducing adjuvants, such as saponin QS21 and monophosphoryl lipid A, and administered as a 'prime' to stimulate the immune system against the hepatitis B virus. This priming is followed by a 'boost' with a viral vector (MVA-HBVAC). The drug is currently being evaluated in Phase 1b/2a clinical trials for the treatment of chronic hepatitis B, aiming to induce a functional cure by restoring effective B-cell and T-cell responses.
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