Study Results

RATES OF PROTECTION >90% ACROSS 3 STUDY POPULATIONS

Regardless of patient type, 2 doses of HEPLISAV-B in 1 month protected >90% of adults across 3 pivotal trials.1

People Achieving Chart
People Achieving Chart

FASTER PROTECTION WITH HEPLISAV-B

95% of those who received HEPLISAV-B were protected after just 2 doses in 1 month.1*

*Compared to 81.3% who received 3 doses of Engerix-B.1

Trial 1: Adults Aged 18 to 55

FASTER AND HIGHER RATES OF PROTECTION WITH HEPLISAV-B

HEPLISAV-B provided statistically significantly higher rates of protection than Engerix-B at every timepoint in adults aged 40 to 70 years.1,4

Trial 2: Adults Aged 40 to 70

HIGHER RATES OF PROTECTION IN HYPORESPONSIVE POPULATIONS

HEPLISAV-B even provided statistically significantly higher rates of protection in diabetics and other known hyporesponsive populations.1,3

Trial 3: Hyporespinsive Populations

SAFETY PROFILE DEMONSTRATED ACROSS TRIALS IN MORE THAN 10,000 PATIENTS4

Data derived from the largest clinical trial safety database (n=14,238) for a hepatitis B vaccine.4

Safety Charts Header
Trial 1 Trial 2
Safety Population 1 Safety Population 2
Trial 1

FASTER PROTECTION WITH HEPLISAV-B

95% of those who received HEPLISAV-B were protected after just 2 doses in 1 month.1*

*Compared to 81.3% who received 3 doses of Engerix-B.1

Percentage of People Aged 18 to 55 Achieving Protective Immunity1†

Protective immunity defined as antibody concentration ≥10 mIU/mL.2

Adults Aged 18 to 55
Trial 2

FASTER AND HIGHER RATES OF PROTECTION WITH HEPLISAV-B

HEPLISAV-B provided statistically significantly higher rates of protection than Engerix-B at every timepoint in adults aged 40 to 70 years.1,4

Percentage of People Aged 40 to 70 Achieving Protective Immunity1,4*

*Protective immunity defined as antibody concentration ≥10 mIU/mL.2

Adults Aged 40 to 70
Trial 3

HIGHER RATES OF PROTECTION IN HYPORESPONSIVE POPULATIONS

HEPLISAV-B even provided statistically significantly higher rates of protection in diabetics and other known hyporesponsive populations.1,3

Percentage of People Aged 18 to 70 Achieving Protective Immunity1,3*

*Protective immunity defined as antibody concentration ≥10 mIU/mL.2

Hyporespinsive Populations
Safety

SAFETY PROFILE DEMONSTRATED ACROSS TRIALS IN MORE THAN 10,000 PATIENTS4

Data derived from the largest clinical trial safety database (n=14,238) for a hepatitis B vaccine.4

Percentage With Local or Systemic Reactions Within 7 Days of Vaccination1

Trial 1 Trial 2
Safety Population 1
Safety Population 2

*Redness and swelling ≥2.5 cm.
Oral temperature ≥100.4°F (38.0°C).

Video Thumbnail

HEPLISAV-B efficacy

Dr. Robert Gish talks about head-to-head results comparing HEPLISAV-B to Engerix-B® and safety results from HEPLISAV-B clinical studies.

Watch full video
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION

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.

IMPORTANT SAFETY INFORMATION

Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., 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%).

Please see full Prescribing Information.

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INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION

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.

IMPORTANT SAFETY INFORMATION

Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., 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%).

Please see full Prescribing Information.

References:

1. HEPLISAV-B [package insert]. Berkeley, CA: Dynavax Technologies Corporation; 2018. 2. Centers for Disease Control and Prevention. Hepatitis B. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:149-174. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepb.pdf. Accessed October 16, 2017. 3. 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. 4. 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.