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Heplisav-B (Hepatitis B Vaccine [Recombinant], Adjuvanted) is a biologic vaccine developed by Dynavax Technologies for the prevention of infection caused by all known subtypes of the Hepatitis B virus in adults aged 18 and older. Approved by the FDA in 2018, it is a recombinant protein subunit vaccine that combines Hepatitis B surface antigen (HBsAg) with a proprietary synthetic cytosine phosphoguanine oligonucleotide adjuvant, CpG 1018. The CpG 1018 adjuvant acts as a Toll-like receptor 9 (TLR9) agonist, stimulating the innate immune system to enhance the adaptive immune response to the HBsAg. This adjuvanted formulation allows for a two-dose immunization series completed within one month, providing a more efficient alternative to traditional three-dose Hepatitis B vaccines.
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