Regardless of patient type, 2 doses of HEPLISAV-B in 1 month protected >90% of adults across 3 pivotal trials1
Trial 1
Compared to 81.3% who received 3 doses of Engerix-B.1
Protective immunity defined as antibody concentration ≥10 mIU/mL.4
CI, confidence interval; SPRs, seroprotection rates.
Trial 2
Protective immunity defined as antibody concentration ≥10 mIU/mL.4
Trial 3
Trial 3 study design: A clinical trial in adults aged 18 to 70 years who received HEPLISAV-B (n=4537) or Engerix-B (n=2289). The primary analysis evaluated the noninferiority of the rate of protective immunity at week 28 induced by HEPLISAV-B (n=640) to Engerix-B (n=321) in patients with type 2 diabetes mellitus. A secondary immunogenicity objective was to demonstrate the noninferiority of the rate of protective immunity with HEPLISAV-B at week 24 compared with Engerix-B at week 28 in all subjects and in subgroups defined by age, sex, body mass index (BMI), diabetes, and smoking status among adults aged 18 to 70 years.5
Protective immunity defined as antibody concentration ≥10 mIU/mL.4
Redness and swelling ≥2.5 cm.1
Oral temperature ≥100.4°F (38.0°C).1
For trial 3, only unsolicited medically attended adverse events, those for which a subject sought medical care, were captured.1
For trials 2 and 3, new-onset autoimmune adverse events are listed. Herpes zoster was reported in 0.7% of HEPLISAV-B patients and 0.3% of patients receiving Engerix-B.1
Find HEPLISAV-B reimbursement information
See DetailsHEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).
There are no clinical studies of HEPLISAV-B in pregnant women. Available human data on HEPLISAV-B administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
It is not known whether HEPLISAV-B is excreted in human milk. Data are not available to assess the effects of HEPLISAV-B on the breastfed infant or on milk production/excretion.
Vaccination with HEPLISAV-B may not result in protection of all vaccine recipients.
HEPLISAV-B does not treat liver diseases such as cirrhosis or liver cancer.1
Not all liver cancer is caused by the hepatitis B virus.6
Please see accompanying full Prescribing Information. Or visit www.heplisavbhcp.com
References: 1. HEPLISAV-B [package insert]. Emeryville, CA: Dynavax Technologies Corporation; 2023. 2. Data on file. Dynavax Technologies Corporation. FDA advisory committee briefing document: HEPLISAV-B™ (Hepatitis B Vaccine [recombinant], adjuvanted). Presented at: Meeting of the Vaccines and Related Biological Products Advisory Committee; July 28, 2017; Silver Spring, MD. 3. Engerix-B [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2018. 4. Haber P, Schillie S. Hepatitis B. In: Hall E, Wodi AP, Hamborsky J, Morelli V, Schillie S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 14th ed. Public Health Foundation; 2021:143-164. 5. Jackson S, Lentino J, Kopp J, et al. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018;36(5):668-674. doi:10.1016/j.vaccine.2017.12.038 6. Hepatitis B Foundation. Risk factors. Accessed May 13, 2024. https://www.hepb.org/research-and-programs/liver/risk-factors-for-liver-cancer
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.