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VVX001 is a recombinant fusion protein vaccine developed as a therapeutic and preventive vaccine for hepatitis B virus (HBV) infection, particularly targeting individuals who do not respond to conventional HBsAg-based HBV vaccines. The vaccine is based on the preS domain of the HBV surface antigen, which includes the binding site for the sodium taurocholate co-transporting polypeptide (NTCP), a key receptor mediating HBV entry into hepatocytes. Immunization with VVX001 induces strong and sustained preS-specific antibody responses—mainly IgG1 subclass—directed at the N-terminal part of preS containing the NTCP attachment site. It also elicits robust CD4+ T cell responses and a mixed Th2/Th1 cytokine profile, leading to high levels of in vitro HBV neutralization across multiple genotypes. The vaccine is being developed by Viravaxx AG and has reached Phase II clinical development[1][2][3][4][7].
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