• 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:
  • VO 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).

• Vaccine Ontology ID: VO_0004359
• Type: DNA vaccine
• Status: Research
• Host Species as Laboratory Animal Model: Human
• HbS gene engineering:
  • Type: DNA vaccine construction
  • Description: Vector pcDNA3 expressed carcinoembryonic antigen (CEA) and hepatitis B surface antigen (HBsAg) (Conry et al., 2002).
  • Detailed Gene Information: Click Here.
• Vector: pcDNA3 (Conry et al., 2002)
• Immunization Route: Intramuscular injection (i.m.)

• Vaccine Ontology ID: VO_0004251
• Type: Subunit vaccine
• Status: Research
• Antigen: Recombinant S gene of hepatitis B (Quiroga et al., 1990).
• Adjuvant:
  • VO ID: VO_0001296
• Immunization Route: Intramuscular injection (i.m.)

• Product Name: Hepatitis B Vaccine (Recombinant)
• Tradename: Recombivax HB
• Manufacturer: Merck & Co, Inc
• Vaccine Ontology ID: VO_0010737
• CDC CVX code: 08, 43,
• Type: Subunit vaccine
• Status: Licensed
• Location Licensed: USA (License #0002)
• Host Species for Licensed Use: Human
• Antigen: Hepatitis B surface antigen (HBsAg) produced in yeast cells.
• Adjuvant:
  • VO ID: VO_0000127
• Preparation: RECOMBIVAX HB is a sterile suspension for intramuscular injection. It is a non-infectious subunit viral vaccine derived from hepatitis B surface antigen (HBsAg) produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories. The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg (Merck: Recombivax HB).
• Storage: Store vials and syringes at 2-8°C (36-46°F). Do not freeze.
• Approved Age for Licensed Use: All ages
• Contraindication: RECOMBIVAX-HB should not be administered to anyone with a known hypersensitivity to yeast or any component of the vaccine.

• Product Name: Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine
• Tradename: Twinrix
• Manufacturer: GlaxoSmithKline Biologicals
• Vaccine Ontology ID: VO_0000113
• CDC CVX code: 104
• Type: Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA (License #1617), Canada
• Host Species for Licensed Use: Human
• Allergen: Neomycin, latex
• Preparation: TWINRIX is a sterile suspension of inactivated hepatitis A virus (strain HM175) propagated in MRC-5 cells, and combined with purified surface antigen of the hepatitis B virus.
• Immunization Route: Intramuscular injection (i.m.)
• Storage: TWINRIX should be refrigerated between 2° and 8° C (36° and 46° F). Do not freeze.
• Approved Age for Licensed Use: Ages 18 and older
• Contraindication: TWINRIX should not be administered to anyone with known hypersensitivity to any component of the vaccine, including yeast and neomycin and in patients with previous hypersensitivity to TWINRIX or monovalent hepatitis A or hepatitis B vaccines (FDA: TWINRIX).

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

Human Response

• Vaccine Immune Response Type: VO_0000286
• Immune Response: CEA-specific antibody and lymphoproliferative responses have been reported after vaccination with an anti-idiotype monoclonal antibody mimicking a portion of the CEA molecule in patients with colorectal carcinoma (Conry et al., 2002).
• Efficacy: Repetitive dosing of pCEA/HBsAg induced HBsAg antibodies in 6 of 8 patients, with protective antibody levels achieved in 4 of these patients. (Conry et al., 2002).

Human Response

• Vaccination Protocol: 81 adult white hemodialysis patients (46 men, 35 women aged 19-65 yrs) with no serological evidence of immunity to hepatitis B were used in the study. Patients were randomly allocated to one of two groups. Group I comprised 41 patients who recieved 40μg of recombinant (S gene) hepatitis B vaccine by i.m. injection and 0,1, and 6 months. Group II comprised 40 patients who received 40 μg of recombinant (S gene) hepatitis B vaccine given intramuscularly with 2 million units (MU) of rIFN-gamma/m^2 body surface given subcutaneously at 0,1, and 6 months (Quiroga et al., 1990).
• Immune Response: The titers of anti-HBs achieved among patients who received vaccine and rIFN-gamma were higher than among those receiving the vaccine alone (Quiroga et al., 1990).

Human Response

• Side Effects: Side effects included: pain, redness and swelling of the injection site, fatigue, fever, headache and nausea.

Human Response

• Immune Response: In clinical trials, it has been found that combining the hepatitis A antigen with the hepatitis B surface antigen in TWINRIX resulted in comparable anti-HAV or anti-HBsAg titers, relative to vaccination with the individual monovalent vaccines or the concomitant administration of each vaccine in opposite arms (FDA: TWINRIX).
• Side Effects: Side effects of immunization included: redness, itching and swelling of the injection site, headache and fatigue. Severe adverse effects were limited and resolved in a timely matter.