Components of

Hepatitis B Vaccines

Components Page
Excipients Table
Allergens Table
       
Name Engerix-B HEPLISAV-B Recombivax HB
Manufacturer GlaxoSmithKline Dynavax Merck
Viability Inactivated Inactivated Inactivated
Indicated Ages All ages 18 years and older  
Dose 0-19yrs: 0.5mL
20+ yrs: 1 mL
Adults on hemodialysis: 2 mL
0.5 mL 0-19yrs: 0.5mL
11-15yrs: either 3x0.5mL or 2x1.0mL doses
20+ yrs: 1.0 mL
Schedule 3 doses: all ages
Hemodialsis: 4 doses
2 doses 3 doses
11-15 yrs may choose 2 x 1.0mL doses
Route Intramuscular Intramuscular Intramuscular
Appearance Homogeneous, turbid white Clear to slightly opalescent, colorless to slightly yellow Slightly opaque, white
Concentration 20 mcg/1.0 mL dose ≥10 mIU/mL Ped/Adolescent: 5 mcg
Adult: 10 mcg
Dialysis: 40 mcg
Preservative None None None
Adjuvant Aluminum Hydroxide, ≤ 0.5 mg/mL CpG 1018 adjuvant Amorphous aluminum hydroxyphosphate sulfate
Excipients • Sodium chloride, 9 mg
• Disodium phosphate dihydrate, 0.98 mg
• Sodium dihydrogen phosphate dihydrate, 0.71 mg
• Yeast protein, ≤5.0%
• Yeast DNA, <20 pg
• Deoxycholate, <0.9 ppm
• Sodium Chloride, 9.0 mg/mL
• Sodium phosphate, diabasic dodecahycrate, 1.75 mg/mL
• Sodium phosphate, monobasic dihydrate, 0.48 mg/mL
• Polysorbate 80, 0.1 mg/mL
Aluminum, 0.5 mg
Formaldehyde, <15 mcg/mL
Allergens Yeast protein, <5% or plasmid DNA Yeast protein,  ≤5.0%
• Yeast DNA, <20 pg
Yeast protein, <1%
Media Saccharomyces cerevisiae cells Hansenula polymorpha yeast Saccharomyces cerevisiae cells
Packaging Vials and Prefilled TIP-LOK syringes 0.5 mL and 1 mL single-dose vials 0.5 mL and 1 mL single-dose vials
Storage 2 to 8 C (36-46 F)
Do not freeze
2 to 8 C (36-46 F)
Do not freeze
2 to 8 C (36-46 F)
Do not freeze
PI date May 2016 Nov 2017 Nov 2014
      Table last updated 3/6/18