What are the different types of Hepatitis B (HBV) vaccines?

Types of Hepatitis B Vaccines

In the United States, there are three monovalent (single-antigen) hepatitis B vaccines—Recombivax HB, Engerix-B, and Heplisav-B—plus one combination vaccine (Twinrix) that protects against both hepatitis A and B. 1

Monovalent (Single-Antigen) Vaccines

All hepatitis B vaccines available in the United States use recombinant DNA technology to produce hepatitis B surface antigen (HBsAg) in yeast, which is then purified through biochemical and biophysical separation techniques. 1

Recombivax HB (Merck)

• Approved for all ages starting from birth 1
• Contains 10-40 μg of HBsAg protein/mL depending on formulation 1
• Standard 3-dose schedule at 0,1, and 6 months 1
• Unique 2-dose option: The adult formulation (10 μg) can be given to adolescents aged 11-15 years on a simplified 2-dose schedule with a 4-month minimum interval between doses 1
• Higher dose formulation (40 μg) available for hemodialysis patients and immunocompromised individuals 1

Engerix-B (GlaxoSmithKline)

• Approved for all ages starting from birth 1
• Contains 10-40 μg of HBsAg protein/mL depending on formulation 1
• Standard 3-dose schedule at 0,1, and 6 months 1
• Flexible scheduling: Can be administered at 0,1, and 4 months or 0,2, and 4 months as alternatives 1
• 4-dose accelerated schedule: Licensed for all age groups at 0,1,2, and 12 months when rapid protection is needed 1
• Higher dose formulation (40 μg given as two 1.0-mL doses at one site) available for hemodialysis patients on a 4-dose schedule 1

Heplisav-B (Dynavax)

• Adults only (≥18 years): Not approved for infants, children, or adolescents 1
• Contains 20 μg of HBsAg with a novel adjuvant 1
• Major advantage: 2-dose schedule (0 and 1 month) instead of 3 doses 1
• Superior immunogenicity: Achieves approximately 90% seroprotection compared to 70.5-90.2% with Engerix-B 1
• Important limitation: Should not be used in hemodialysis patients, immunocompromised individuals, or pregnant women due to insufficient safety data 1

Combination Vaccines

Twinrix (GlaxoSmithKline)

• Adults only (≥18 years in the United States) 1
• Contains recombinant HBsAg (20 μg) plus inactivated hepatitis A virus 1
• Standard 3-dose schedule at 0,1, and 6 months 1
• Accelerated schedule available: 4 doses at days 0,7, and 21-30, followed by a booster at 12 months for travelers needing rapid protection 1
• Use only when both hepatitis A and B protection are indicated—do not use for hepatitis B vaccination alone 1

Pediatric Combination Vaccines

• Pediarix (GlaxoSmithKline): For infants/children aged 6 weeks to 6 years; combines HBsAg with DTaP and inactivated poliovirus 1
• Comvax (Merck): Previously combined HBsAg with Haemophilus influenzae type b vaccine for ages 6 weeks to 15 months, but no longer available as of 2015 1

Key Formulation Details

All current U.S. hepatitis B vaccines are thimerosal-free or contain only trace amounts (<1.0 μg mercury/mL) from manufacturing. 1

Dosing varies significantly by age and medical condition, ranging from 5 μg for infants to 40 μg for hemodialysis patients. 1

Common Pitfalls to Avoid

• Do not use Heplisav-B in children, pregnant women, or hemodialysis patients—it is only approved and studied in healthy adults aged ≥18 years 1
• Do not use Twinrix solely for hepatitis B protection—reserve it for patients who need protection against both hepatitis A and B 1
• Do not use standard adult doses in hemodialysis patients—they require the 40 μg dialysis formulation for adequate immune response 1
• Do not restart the vaccine series if interrupted—simply continue where you left off, as restarting wastes doses and delays protection 1