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Dr. Wang reports no financial relationships relevant to this field of study.
Heplisav-B is a new hepatitis B vaccine approved by the FDA in November 2017. The indication for Heplisav-B is the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults 18 years of age or older. Heplisav-B contains an antigen similar to other HBV vaccines currently on the market. However, it uses a synthetic oligonucleotide 1018 instead of alum as an adjuvant. This new adjuvant stimulates rapid activation of the innate immune system via toll-like receptor 9 (TLR9) and supports the induction of B and T lymphocytes in the adaptive immune system.1-5
Heplisav-B is administered in two doses over one month. This compares favorably to older HBV vaccines, which are given in three doses over a six-month period. Nelson et al conducted a population-based study using the Vaccine Safety Datalink from 1997-2004. The researchers showed low compliance rates with the three-dose hepatitis B vaccine series. Less than 60% of the HBV vaccine initiators completed the three-dose series. Compliance rates were low at 45% among adolescents and 41% in 18-29 year olds at one year. Table 1 lists costs and formulations currently available in the United States.1-5
GUIDELINES
Heplisav-B was discussed in a meeting of the Advisory Committee on Immunization Practices (ACIP) on Feb. 12, 2018. Per Dynavax’s press release on Feb. 21, 2018, “Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously in favor of including Heplisav-B on its list of ACIP recommended products for use to vaccinate adults against hepatitis B.” CDC will review and approve the ACIP recommendations before publishing in the Morbidity and Mortality Weekly Report (MMWR).6
CLINICAL TRIALS
The immunogenicity of Heplisav-B was studied in three pivotal trials. These trials were multi-center, observer-blinded, randomized,...