• Vaccine Name: Engerix-B
• Target Pathogen: Hepatitis B virus
• Target Disease: Hepatitis B
• Product Name: Hepatitis B Vaccine (Recombinant)
• Tradename: Engerix-B
• Manufacturer: GlaxoSmithKline Biologicals
• Vaccine Ontology ID: VO_0010711
• CDC CVX code: 08, 44
• Type: Subunit vaccine
• Status: Licensed
• Location Licensed: USA (License #1617)
• Host Species for Licensed Use: Human
• Antigen: Hepatitis B surface antigen
• Adjuvant:
  • Adjuvant name:
  • VO adjuvant ID: VO_0000127
• Preparation: ENGERIX-B contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The surface antigen expressed in Saccharomyces cerevisiae cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. Each 0.5-mL dose contains 10 mcg of hepatitis B surface antigen adsorbed on 0.25 mg aluminum as aluminum hydroxide (FDA: ENGERIX-B).
• Storage: Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze.
• Approved Age for Licensed Use: All ages
• Contraindication: ENGERIX-B should not be administered to anyone with known hypersensitivity to any component of the vaccine, including yeast and any previous hypersensitivity to any hepatitis B-containing vaccine.
• Description: ENGERIX-B is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It is manufactured by GlaxoSmithKline Biologicals. It is licensed for human use in USA (FDA: ENGERIX-B).

Human Response

• Vaccination Protocol: Many clinical trials were conducted on subjects ranging in ages from 6 months old to 65 years.
• Side Effects: Side Effects of vaccination with ENGERIX-B include: redness, swelling and pain of the injection site, fever, headache and dizziness