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Higher rates of protection with HEPLISAV‑B1,2

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In a pivotal study of adults aged 18–55, 95% of those who received HEPLISAV‑B were protected after only 2 doses in 1 month, in a 3-month, head-to-head study vs Engerix‑B*

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STUDY 1: Percentage of participants achieving protective immunity†

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In study 1, 95% of those who received HEPLISAV-B 2-dose series (n=1511) achieved protective immunity after only 2 doses in 1 month by the 3-month mark. 98.2% of that group achieved protective immunity at the 6-month mark. Versus Engerix-B 3-dose series (n=521), 32.7% achieved protective immunity after 3 doses in 6 months at the 6-month mark, and 81.3% of that group achieved protective immunity at the 7-month mark.
  • Noninferiority was met because the 95% CI lower bound of the difference in SPRs was greater than -10%
  • 13.7% difference (95% CI, 10.4–17.5) in protective immunity between patient groups at primary endpoint
  • The primary analysis compared the rate of protective immunity at week 12 for HEPLISAV‑B with that at week 28 for Engerix‑B

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

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


CI=confidence interval; SPRs=seroprotection rates

Faster and higher rates of protection with HEPLISAV‑B1,2

Statistically significantly higher rates of protection with HEPLISAV‑B vs Engerix‑B at every timepoint in adults aged 40–70 years

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STUDY 2: Percentage of participants aged 40–70 achieving protective immunity†

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In study 2, 90.1% of adults aged 40-70 years who received HEPLISAV-B 2-dose series (n=1121) achieved protective immunity by month 3 (primary endpoint). 95.1% achieved protective immunity by month 6 and this remained steady through the 12-month mark. 21.5% of adults aged 40-70 years who received Engerix-B 3-dose series (n=353) achieved protective immunity by month 6. 72.9% achieved protective immunity by month 7, and 70.5 achieved protective immunity by month 9 (primary endpoint) and this declines slightly through the 12-month mark.
  • 19.6% (95% CI, 14.7–24.8) difference in protective immunity between patient groups at primary endpoint
  • The primary analysis compared the rate of protective immunity at week 12 for HEPLISAV‑B with that at week 32 for Engerix‑B
  • Noninferiority was met because the lower bound of the 95% confidence interval of the difference in SPRs was greater than -10%. The SPR following HEPLISAV‑B was statistically significantly higher than following Engerix‑B (lower bound of the 95% confidence interval of the difference in SPRs was greater than 0%).

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

Higher rates of protection in adults with diabetes and other known hyporesponsive populations1,2

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STUDY 3: Percentage of participants aged 18–70 achieving protective immunity†

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ADULTS WITH DIABETES ACHIEVING PROTECTIVE IMMUNITY1,2

Study 3 demographic information: Columns from left to right: HEPLISAV-B (90.0%), Engerix-B (65.1%). Rows: Total trial population (n=6665): 95.4% and 81.3%. Male (n=3353): 94.5% and 78.8%. Aged 40-70 (n=5434): 94.6% and 78.7%. Obesity (n=3241): 94.7% and 75.4%. Smokers (n=2082): 95.9% and 78.6%. Study 3 demographic information: Columns from left to right: HEPLISAV-B (90.0%), Engerix-B (65.1%). Rows: Total trial population (n=6665): 95.4% and 81.3%. Male (n=3353): 94.5% and 78.8%. Aged 40-70 (n=5434): 94.6% and 78.7%. Obesity (n=3241): 94.7% and 75.4%. Smokers (n=2082): 95.9% and 78.6%.

Trial 3 study design: A clinical trial in adults aged 18 to 70 years who received HEPLISAV‑B (n=4376) or Engerix‑B (n=2289).

  • The primary analysis compared the seroprotection rate at week 24 for HEPLISAV‑B (n=640) with that at week 28 for Engerix‑B (n=321) in subjects with type 2 diabetes mellitus. Non-inferiority of the seroprotection rate induced by HEPLISAV‑B compared to Engerix‑B was demonstrated.
  • A secondary analysis compared the seroprotection rate at week 24 for HEPLISAV‑B with that at week 28 for Engerix‑B in the total study population. Non-inferiority of the seroprotection rate induced by HEPLISAV‑B compared to Engerix‑B was demonstrated.
  • Other secondary analyses compared the seroprotection rate at week 24 for HEPLISAV‑B with that at week 28 for Engerix‑B, in subgroups defined by age, sex, body mass index (BMI), diabetes, and smoking status among adults aged 18 to 70 years. For each subgroup non-inferiority of the seroprotection rate induced by HEPLISAV‑B compared to Engerix‑B was demonstrated.

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

Study Design

The immunogenicity of HEPLISAV‑B was evaluated in comparison with a licensed hepatitis B vaccine (Engerix‑B) in 3 randomized active-controlled, observer-blinded, multicenter Phase 3 clinical trials of adults. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by saline placebo at 6 months. Engerix‑B was given at 0, 1, and 6 months. The trials compared the seroprotection rates (% with antibody concentration ≥10 mIU/mL) induced by HEPLISAV‑B and Engerix‑B.1

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Safety Profile
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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 (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV‑B, including yeast.

IMPORTANT SAFETY INFORMATION
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.

ADDITIONAL IMPORTANT INFORMATION
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.3

Please see full Prescribing Information.

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. National Cancer Institute. Liver cancer causes, risk factors, and prevention. Last updated May 15, 2024. Accessed July 15, 2024. https://www.cancer.gov/types/liver/what-is-liver-cancer/causes-risk-factors