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Heplisav-B
- Development stage
- Approved
- Lead developer
- Dynavax Technologies
- Modality
- MicroRNA (miRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Recombinant Proteins and Enzymes, Antisense Oligonucleotides (ASOs) → Long RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Antisense DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Small Interfering RNA (siRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Vaccines & Immunotherapeutics
- Administration
- Intramuscular
01
Overview
**Heplisav-B** is an FDA-approved recombinant, adjuvanted hepatitis B vaccine for prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. The vaccine contains recombinant hepatitis B surface antigen produced in *Hansenula polymorpha* yeast and the CpG 1018 synthetic oligodeoxynucleotide adjuvant, a Toll-like receptor 9 agonist. It induces hepatitis B surface antigen-specific immune responses, while CpG 1018 enhances innate immune activation and adaptive antibody responses. Heplisav-B is administered as two 0.5 mL intramuscular doses one month apart. It was originally developed by Dynavax and became part of Sanofi following Sanofi's acquisition of Dynavax in February 2026.
- Brand names
- HEPLISAV-B
- Other names
- Hepatitis B Vaccine Recombinant AdjuvantedHepB-CpG
02
Targets
TLR9 (Toll-like receptor 9)MHC II (Major histocompatibility complex class II receptor)
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