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HEPLISAV-B (Dynavax Technologies)
- Development stage
- Unknown
- 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 a monovalent, recombinant, adjuvanted vaccine developed by Dynavax Technologies for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults. The vaccine consists of the hepatitis B surface antigen (HBsAg) combined with a proprietary Toll-like receptor 9 (TLR9) agonist adjuvant, known as 1018 Immunostimulatory Sequence (ISS). The 1018 ISS adjuvant is a synthetic 22-mer oligonucleotide that stimulates the innate immune system to enhance the adaptive immune response against the HBsAg. This advanced adjuvant system allows for a two-dose regimen administered over one month, providing a faster and more convenient immunization schedule compared to traditional three-dose, six-month alum-adjuvanted vaccines. HEPLISAV-B was approved by the FDA in 2017 and is specifically indicated for adults aged 18 and older, including those with chronic conditions such as end-stage renal disease.
- Brand names
- HEPLISAV-B
- Other names
- ISS-HBsAg-SingleHepatitis B Vaccine (Recombinant), Adjuvanted
02
Targets
TLR9 (Toll-like receptor 9)
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