HEPLISAV-B is a Recombinant Hepatitis B Vaccine with CpG Adjuvant
HEPLISAV-B is a two-dose recombinant hepatitis B vaccine containing hepatitis B surface antigen (HBsAg) combined with a CpG 1018 adjuvant, approved for adults aged ≥18 years and administered at 0 and 1 month 1, 2.
Key Characteristics
Composition and Mechanism
- Contains 20 μg of recombinant HBsAg per 0.5 mL dose 1
- Uses CpG 1018 adjuvant (a synthetic oligonucleotide with CpG motifs) that stimulates innate immunity through Toll-like receptor 9 (TLR9) 3
- This adjuvant system enhances immune response compared to conventional alum-adjuvanted vaccines
Dosing Schedule
- Two-dose regimen: 0 and 1 month 1
- Significantly shorter than conventional 3-dose vaccines (Engerix-B, Recombivax HB) which require 0,1, and 6 months
- Administered intramuscularly only 2
- Must be stored at 2-8°C (36-46°F); do not freeze 2
Clinical Performance
Superior Efficacy
HEPLISAV-B demonstrates seroprotection rates of 90-100% compared to 71-90% with conventional Engerix-B across four randomized controlled trials involving over 10,000 subjects 3. The vaccine achieves:
- Earlier seroprotection (after just 1 month vs. 6 months)
- Higher antibody titers
- Better completion rates due to simplified schedule (81% vs. 60% for Recombivax HB) 4
Enhanced Response in Difficult-to-Vaccinate Populations
The CpG adjuvant provides particular benefit in populations with traditionally poor vaccine responses 3:
- Older adults (≥60 years)
- Patients with diabetes
- Chronic kidney disease patients
- People living with HIV 5
Important Clinical Restrictions
Populations Where HEPLISAV-B Should NOT Be Used
Pregnant women should receive Engerix-B, Recombivax HB, or Twinrix instead of HEPLISAV-B 1. Data are currently insufficient to inform vaccine-associated risks in pregnancy.
Adults on hemodialysis should NOT receive HEPLISAV-B 1. Safety and effectiveness have not been established in this population. Use Engerix-B (40 μg, 4-dose series) or Recombivax HB (40 μg, 3-dose series) instead.
Additional Limitations
- Insufficient data on effects during breastfeeding 1
- Not established for other immunocompromised adults on hemodialysis 1
Clinical Pearls
When to Choose HEPLISAV-B
This vaccine is particularly advantageous for:
- Adults aged 19-59 years requiring hepatitis B vaccination 1
- Patients with compliance concerns (shorter schedule improves completion)
- Populations with poor response to conventional vaccines
- Healthcare workers needing rapid seroprotection 6
Post-Vaccination Monitoring
For thoracic organ transplant recipients, pretransplant vaccination with achieved seroprotection (HBsAb ≥10 IU/L) is optimal 7. Completing both doses post-transplant results in only 36% seroprotection compared to 71% when completed pre-transplant with documented response.
Safety Profile
The safety profile is similar to conventional hepatitis B vaccines across nearly 10,000 subjects studied 3. No significant safety concerns have emerged beyond standard vaccine reactions.