2-DOSE HEPLISAV-B CAN MAKE SERIES COMPLETION EASIER AND PROTECT PATIENTS FASTER1-3

Regardless of patient type, 2 doses of HEPLISAV-B in 1 month protected >90% of adults across 3 pivotal trials1

 

FASTER PROTECTION WITH HEPLISAV-B1-3

95% of those who received HEPLISAV-B were protected after just 2 doses1,2,*

Trial 1

PERCENTAGE OF PEOPLE AGED 18 TO 55 ACHIEVING PROTECTIVE IMMUNITY

95% of those who received HEPLISAV-B were protected after 2 doses in 1 month[1,2*] 95% of those who received HEPLISAV-B were protected after 2 doses in 1 month[1,2*]
  • 13.7% difference (95% CI, 10.4-17.5) in protective immunity between patient groups at primary endpoint1
  • The primary analysis compared the rate of protective immunity at week 12 for HEPLISAV-B with that at week 28 for Engerix-B1
  • Statistical significance was met; however, statistical significance was not prespecified in trial 12
  • Noninferiority was met because the 95% CI lower bound of the difference in SPRs was greater than -10%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.

 

FASTER AND HIGHER RATES OF PROTECTION WITH HEPLISAV-B1-3

Statistically significantly higher rates of protection with HEPLISAV-B vs Engerix-B at every timepoint in adults aged 40 to 70 years1,2

Trial 2

PERCENTAGE OF PEOPLE AGED 40 TO 70 ACHIEVING PROTECTIVE IMMUNITY*

Get higher rates of protection with HEPLISAV-B[1,2] Get higher rates of protection with HEPLISAV-B[1,2]
  • 19.6% (95% CI, 14.7-24.8) difference in protective immunity between patient groups at primary endpoint1,2
  • The primary analysis compared the rate of protective immunity at week 12 for HEPLISAV-B with that at week 32 for Engerix-B1

Protective immunity defined as antibody concentration ≥10 mIU/mL.4

 

HIGHER RATES OF PROTECTION IN HYPORESPONSIVE POPULATIONS1,5

HEPLISAV-B provided statistically significantly higher rates of protection in people with diabetes and other known hyporesponsive populations1,5

Trial 3

PERCENTAGE OF PEOPLE AGED 18 TO 70 ACHIEVING PROTECTIVE IMMUNITY*

HEPLISAV-B provided statistically higher rates of protection in people with diabetes and other known hyporesponsive populations[1,5] HEPLISAV-B provided statistically higher rates of protection in people with diabetes and other known hyporesponsive populations[1,5]

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

 

SAFETY PROFILE DEMONSTRATED ACROSS TRIALS IN MORE THAN 10,000 PATIENTS2

Data derived from the largest clinical trial safety database (N=14,238) for a hepatitis B vaccine2

Percentage With Local or Systemic Reactions Within 7 Days of Vaccination1

Safety profile demonstrated across trial 1 Safety profile demonstrated across trial 1

Percentage With Local or Systemic Reactions Within 7 Days of Vaccination1

Safety profile demonstrated across trial 2 Safety profile demonstrated across trial 2

Redness and swelling ≥2.5 cm.1

Oral temperature ≥100.4°F (38.0°C).1

SAFETY PROFILE DEMONSTRATED ACROSS 3 TRIALS WITH 12 MONTHS OF FOLLOW-UP2

Unsolicited adverse events reported in 3 pivotal clinical trials

Percentage WHO EXPERIENCED ADVERSE EVENTS AFTER VACCINATION1

Unsolicited adverse events reported in 3 HEPLISAV-B pivotal clinical trials Unsolicited adverse events reported in 3 HEPLISAV-B pivotal clinical trials

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

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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%).

References: 1. HEPLISAV-B [package insert]. Emeryville, CA: Dynavax Technologies Corporation; 2020. 2. 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

See the CDC recommendation

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.