Hepatitis B Vaccine (Recombinant)

Identification

Name
Hepatitis B Vaccine (Recombinant)
Accession Number
DB11627
Description

Hepatitis B Vaccine is an ingredient in the EMA-withdrawn product Quintanrix. It is marketed in Canada as Engerix B. It is also a part of Twinrix (Hep A/Hep B vaccine) available also in Canada. The hepatitis B virus induces a severe form of viral hepatitis. Other causative agents are hepatitis A virus, and the non-A, non-B hepatitis viruses. Hepatitis D virus, a defective virus requiring the “keeper function” of the hepatitis B virus, occurs either as a co-infection or super-infection in a HBsAg carrier.

Transmission of the virus occurs through percutaneous contact with contaminated blood, serum or plasma. Infection may also occur by the exposure of mucous surfaces, or intact or damaged skin to other body fluids such as saliva, mucosal secretions and semen.

There is no specific treatment for hepatitis. The incubation period may be as long as 6 months, followed by a very complex clinical course of an acute or chronic nature, often leading to hospitalization.

Viral hepatitis caused by hepatitis B virus is a major worldwide health problem, though the incidence and epidemiology vary widely among geographical areas and population subgroups.

In Canada, the United States and Northern Europe, 4% to 6% of the population are infected during their lifetime (mostly young adults); between 5% and 10% of infections lead to persistent viremia (carrier state). Certain population subgroups in these areas, however, are at high risk (see Indications and Clinical Use).

In Asia, infection often occurs early in life, leading to a hepatitis B marker prevalence of more than 70% in the general population and a carrier rate of up to 20%.

It is estimated that the reservoir of persistent hepatitis B surface antigen carriers amounts to 350 million people worldwide. Carriers are at a high risk of developing chronic liver disease which may lead to cirrhosis or primary hepatocellular carcinoma. A significant reduction in the incidence of hepatocellular carcinoma has been observed in children aged 6 to14 years following a nationwide hepatitis B vaccination in Taiwan. This resulted from a significant decline in the prevalence of hepatitis B antigen, the persistence of which is an essential factor in the development of hepatocellular carcinoma.

Vaccination against hepatitis B is expected in the long term to reduce the overall incidence of both hepatitis B and the chronic complications such as chronic active hepatitis and cirrhosis.

Type
Biotech
Groups
Approved, Withdrawn
Biologic Classification
Vaccines
Inactivated / Recombinant
Synonyms
  • HBSAG
  • Hepatitis B antigen
  • Hepatitis B surface antigen
  • Hepatitis B Surface Antigen (rDNA)
  • Hepatitis B surface antigen (recombinant)
  • Hepatitis B surface antigen vaccine
  • Hepatitis B surface antigens
  • Hepatitis B Vaccine
  • Hepatitis B virus hbsag surface protein antigen
  • Hepatitis-B surface antigen

Pharmacology

Indication

Active immunization against hepatitis B virus infection.

The vaccine will not protect against infection caused by hepatitis A and non-A non-B hepatitis viruses. As hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection or carrier state, it can be expected that hepatitis D will also be prevented by vaccination with hepatitis B virus vaccine.

The vaccine can be administered at any age from birth onwards. It may be used to start a primary course of vaccination or as a booster dose. It may also be used to complete a primary course of vaccination started with plasma-derived or yeast-derived vaccines or as a booster dose in subjects who have previously received a primary course of vaccination with plasma-derived or yeast-derived vaccines.

In areas of low prevalence of hepatitis B, vaccination is strongly recommended in subjects who are at increased risk of infection. These include the following groups:

  • Health professionals: physicians and surgeons; oral surgeons and dentists; nurses, dental nurses, dental hygienists, podiatrists; IV teams and operating room personnel; paramedical personnel in close contact with patients; staff in hemodialysis, nephrology, hepatology, hematology and oncology units; laboratory personnel handling blood and other clinical specimens; blood bank and plasma fractionation workers; pathologists and morgue attendants; cleaning staff who handle waste in hospitals; emergency and first aid workers; ambulance staff; dental, medical and nursing students.
  • Patients: patients receiving frequent blood transfusion or clotting factor concentrates, such as those in oncology units and those with thalassemia, sickle-cell anemia, cirrhosis, hemophilia, etc.; patients on hemodialysis; patients with type 2 diabetes.
  • Personnel and residents of institutions: persons with frequent and/or close contacts with high-risk groups; prisoners and prison staff; residents and staff of institutions for the developmentally challenged (those who are in contact with aggressive biting residents being at highest risk).
  • Persons at increased risk due to their sexual practices: males having sexual contact with other males; others with multiple sexual partners or with a recent history of sexually transmitted disease.
  • Persons who use injectable drugs illicitly.
  • Travellers to areas of high endemicity and their close contacts.
  • Household contacts of any of the above groups and of patients with acute or chronic hepatitis B infection.
  • Infants born of HBsAg-positive mothers.
  • Chronic Liver Disease (CLD): subjects with chronic liver disease; subjects at risk of developing CLD (e.g. Hepatitis C virus carriers, persons who abuse alcohol).
  • Others: police; fire fighters; armed forces personnel; morticians and embalmers; those who through their work or personal lifestyle may be exposed to the hepatitis B virus.
  • In areas of both low and high prevalence, vaccination should be offered to all young children and neonates at risk, as well as to adult high risk groups.
Associated Conditions
Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
Learn More
Pharmacodynamics

ENGERIX-B induces specific humoral antibodies against the surface antigen of hepatitis B virus (anti-HBs antibodies). An anti-HBs antibody titre above 10 IU/l correlates with protection to HBV infection.

Mechanism of action

ENGERIX®-B induces specific humoral antibodies against HBsAg (anti-HBs antibodies). It is generally accepted that an anti-HBs titre greater than 10 IU/L correlates with protection against hepatitis B virus infection. More than 90% of healthy adults, children and neonates developed protective anti-HBs titres one month after completing a primary vaccination schedule of ENGERIX®-B (hepatitis B vaccine (recombinant)).

Absorption

Vaccine is intended for intramuscular injection. Evaluation of pharmacokinetic properties is not required for vaccines.

Volume of distribution

Evaluation of pharmacokinetic properties is not required for vaccines.

Protein binding

Evaluation of pharmacokinetic properties is not required for vaccines.

Metabolism

Evaluation of pharmacokinetic properties is not required for vaccines.

Route of elimination

Evaluation of pharmacokinetic properties is not required for vaccines.

Half-life

Evaluation of pharmacokinetic properties is not required for vaccines.

Clearance

Evaluation of pharmacokinetic properties is not required for vaccines.

Adverse Effects
Learn about our commercial Adverse Effects data.
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Toxicity

Cases of overdose have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.

Affected organisms
  • Hepatitis B virus
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbataceptThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Alemtuzumab.
AltretamineThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Altretamine.
AmsacrineThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Amsacrine.
AnakinraThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Anakinra.
Antilymphocyte immunoglobulin (horse)The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Antilymphocyte immunoglobulin (horse).
Antithymocyte immunoglobulin (rabbit)The therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Antithymocyte immunoglobulin (rabbit).
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

    An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions
No interactions found.

Products

Product Ingredients
IngredientUNIICASInChI Key
Hepatitis B virus subtype ADW HBSAG surface protein antigenXL4HLC6JH6Not AvailableNot applicable
Hepatitis B virus subtype ADW2 HBSAG surface protein antigen9GCJ1L5D1P351186-51-1Not applicable
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Engerix-BInjection, suspension20 ug/1mLIntramuscularDispensing Solutions, Inc.2009-05-28Not applicableUS flag
Engerix-BInjection, suspension10 ug/0.5mLIntramuscularGlaxoSmithKline Biologicals SA2007-04-25Not applicableUS flag
Engerix-BInjection, suspension20 ug/1mLIntramuscularA-S Medication Solutions2007-03-28Not applicableUS flag
Engerix-BSuspensionIntramuscularGlaxosmithkline Inc2008-07-252020-04-01Canada flag
Engerix-BSuspensionIntramuscularGlaxosmithkline Inc1991-12-312020-05-26Canada flag
Engerix-BSuspension20 mcgIntramuscularGlaxosmithkline Inc2019-11-15Not applicableCanada flag
Engerix-BInjection, suspension20 ug/1mLIntramuscularPhysicians Total Care, Inc.2002-08-052012-06-30US flag
Engerix-BInjection, suspension20 ug/1mLIntramuscularGlaxoSmithKline Biologicals SA2007-03-28Not applicableUS flag
Engerix-BInjection, suspension10 ug/0.5mLIntramuscularA-S Medication Solutions2007-04-25Not applicableUS flag
Engerix-BSuspension10 mcgIntramuscularGlaxosmithkline Inc2019-10-07Not applicableCanada flag
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
ComvaxHepatitis B virus subtype ADW HBSAG surface protein antigen (5 ug/0.5mL) + Haemophilus influenzae type B capsular polysaccharide meningococcal outer membrane protein conjugate antigen (7.5 ug/0.5mL)Injection, suspensionIntramuscularMerck Sharp & Dohme Limited1996-10-022016-08-19US flag
PediarixHepatitis B virus subtype ADW2 HBSAG surface protein antigen (10 ug/0.5mL) + Bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) (25 ug/0.5mL) + Bordetella pertussis pertactin antigen (formaldehyde inactivated) (8 ug/0.5mL) + Bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) (25 ug/0.5mL) + Clostridium tetani toxoid antigen (formaldehyde inactivated) (10 [iU]/0.5mL) + Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (25 [iU]/0.5mL) + Poliovirus type 1 antigen (formaldehyde inactivated) (40 [iU]/0.5mL) + Poliovirus type 2 antigen (formaldehyde inactivated) (8 [iU]/0.5mL) + Poliovirus type 3 antigen (formaldehyde inactivated) (32 [iU]/0.5mL)Injection, suspensionIntramuscularGlaxoSmithKline Biologicals SA2009-07-24Not applicableUS flag
TwinrixHepatitis B virus subtype ADW2 HBSAG surface protein antigen (20 ug/1mL) + Hepatitis A virus strain HM175 antigen (formaldehyde inactivated) (720 [iU]/1mL)Injection, suspensionIntramuscularA-S Medication Solutions2007-06-07Not applicableUS flag
TwinrixHepatitis B Vaccine (Recombinant) (20 mcg) + Hepatitis A Vaccine (720 unit)SuspensionIntramuscularGlaxosmithkline Inc1997-09-23Not applicableCanada flag
TwinrixHepatitis B virus subtype ADW2 HBSAG surface protein antigen (20 ug/1mL) + Hepatitis A virus strain HM175 antigen (formaldehyde inactivated) (720 [iU]/1mL)Injection, suspensionIntramuscularGlaxoSmithKline Biologicals SA2007-06-07Not applicableUS flag
Twinrix JuniorHepatitis B Vaccine (Recombinant) (10 mcg) + Hepatitis A Vaccine (360 unit)SuspensionIntramuscularGlaxosmithkline Inc1998-11-06Not applicableCanada flag
VaxelisHepatitis B virus subtype ADW HBSAG surface protein antigen (10 ug/0.5mL) + Bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) (20 ug/0.5mL) + Bordetella pertussis fimbriae 2/3 antigen (5 ug/0.5mL) + Bordetella pertussis pertactin antigen (3 ug/0.5mL) + Bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (20 ug/0.5mL) + Clostridium tetani toxoid antigen (formaldehyde inactivated) (5 [Lf]/0.5mL) + Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (15 [Lf]/0.5mL) + Haemophilus influenzae type B capsular polysaccharide meningococcal outer membrane protein conjugate antigen (3 ug/0.5mL) + Poliovirus type 1 antigen (formaldehyde inactivated) (29 [D'ag'U]/0.5mL) + Poliovirus type 2 antigen (formaldehyde inactivated) (7 [D'ag'U]/0.5mL) + Poliovirus type 3 antigen (formaldehyde inactivated) (26 [D'ag'U]/0.5mL)Injection, suspensionIntramuscularMCM Vaccine Co.2018-12-212020-04-10US flag
VaxelisHepatitis B virus subtype ADW HBSAG surface protein antigen (10 ug/0.5mL) + Bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) (20 ug/0.5mL) + Bordetella pertussis fimbriae 2/3 antigen (5 ug/0.5mL) + Bordetella pertussis pertactin antigen (3 ug/0.5mL) + Bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (20 ug/0.5mL) + Clostridium tetani toxoid antigen (formaldehyde inactivated) (5 [Lf]/0.5mL) + Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (15 [Lf]/0.5mL) + Haemophilus influenzae type B capsular polysaccharide meningococcal outer membrane protein conjugate antigen (3 ug/0.5mL) + Poliovirus type 1 antigen (formaldehyde inactivated) (29 [D'ag'U]/0.5mL) + Poliovirus type 2 antigen (formaldehyde inactivated) (7 [D'ag'U]/0.5mL) + Poliovirus type 3 antigen (formaldehyde inactivated) (26 [D'ag'U]/0.5mL)Injection, suspensionIntramuscularMSP Vaccine Company2018-12-21Not applicableUS flag

Categories

Drug Categories
Classification
Not classified

Chemical Identifiers

UNII
IFJ010MNE4
CAS number
Not Available

References

General References
  1. Engerix-B Monograph [Link]
  2. FDA Approved Products: Recombivax HB (hepatitis B) vaccine [Link]
PubChem Substance
347911220
RxNav
797752
Drugs.com
Drugs.com Drug Page
Wikipedia
Hepatitis_B_vaccine
AHFS Codes
  • 80:12.00 — Vaccines

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingBasic ScienceImmunization; Infection / Viral Hepatitis B1
4Active Not RecruitingPreventionHepatitis B Vaccine1
4Active Not RecruitingPreventionViral Hepatitis B1
4CompletedNot AvailableViral Hepatitis B1
4CompletedBasic ScienceViral Hepatitis B1
4CompletedPreventionAcellular Pertussis / Diphtheria / Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines / Haemophilus Influenzae Type B / Poliomyelitis / Tetanus / Viral Hepatitis B1
4CompletedPreventionAcellular Pertussis / Diphtheria / Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines / Poliomyelitis / Tetanus1
4CompletedPreventionAcellular Pertussis / Diphtheria / Poliomyelitis / Tetanus / Viral Hepatitis B1
4CompletedPreventionChronic Infection / Hepatitis B Infection / Viral sepsis1
4CompletedPreventionDrug Therapy, Combination / Fever, Chemically Induced / Infants / Vaccines, Pneumococcal1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, suspensionIntramuscular
Injection, suspensionIntramuscular10 mcg/0.5mL
Injection, suspensionIntramuscular10 MICROGRAMMI
Injection, suspensionIntramuscular20 mcg/mL
Injection, suspensionIntramuscular; Subcutaneous10 mcg/0.5mL
Injection, suspensionIntramuscular; Subcutaneous20 mcg/mL
Injection, suspensionIntramuscular10 ug/0.5mL
Injection, suspensionIntramuscular20 ug/1mL
SuspensionIntramuscular
SuspensionIntramuscular10 mcg
Suspension
Injection, suspensionParenteral10 Mikrogramm/0.5ml
Injection, suspensionParenteral20 Mikrogramm/1ml
SuspensionIntramuscular20 mcg/1ml
SuspensionIntramuscular10 mcg/0.5ml
SuspensionIntramuscular20 cg
InjectionIntramuscular20 μg/ml
Injection, suspensionIntramuscular20 mcg/0.5ml
SuspensionIntramuscular20 µg
SuspensionIntramuscular10 µg
Injection, suspensionIntramuscular10 MCG/ML
Injection, suspensionIntramuscular40 MCG/ML
Injection, suspensionIntramuscular5 mcg/0.5mL
Injection, suspensionIntramuscular; Subcutaneous10 mcg/mL
Injection, suspensionIntramuscular; Subcutaneous5 mcg/0.5mL
SuspensionIntramuscular10 µg/ml
SuspensionIntramuscular5 mcg/0.5ml
Injection, solutionIntramuscular20 ug/0.5mL
Injection, suspensionIntramuscular20 UI
Injection, solutionIntramuscular20 IU
Injection, powder, for suspensionIntramuscular25 mcg
Injection, powder, for suspensionIntramuscular25 mcg/0.5mL
Injection, powder, for suspensionIntramuscular30 UI
SuspensionIntramuscular30 UI
Injection, powder, for suspensionIntramuscular10 mcg
Injection, suspensionIntramuscular10 ug/1mL
Injection, suspensionIntramuscular; Subcutaneous10 ug/1mL
Injection, suspensionIntramuscular; Subcutaneous40 ug/1mL
Injection, suspensionIntramuscular; Subcutaneous5 ug/0.5mL
SolutionIntramuscular
Injection, suspensionIntramuscular10 mcg
Injection, suspensionIntramuscular20 mcg
Injection, suspensionIntramuscular360 Unità ELISA
Injection, suspensionIntramuscular720 Unità ELISA
SuspensionIntramuscular
SuspensionIntramuscular720 ELU
SuspensionIntramuscular360 ELU
SuspensionIntramuscular20 mcg
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created on October 17, 2016 15:25 / Updated on October 29, 2020 19:26

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