Hepatitis B Vaccine (Recombinant)

Identification

Name
Hepatitis B Vaccine (Recombinant)
Accession Number
DB11627  (DB10308, DB10993)
Type
Biotech
Groups
Approved, Withdrawn
Biologic Classification
Vaccines
Inactivated / Recombinant
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Hepatitis B Vaccine is an ingredient in the EMA-withdrawn product Quintanrix.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.

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
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
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Engerix B Inj Sus 20mcg/mlSuspension20 mcgIntramuscularGlaxosmithkline Inc1991-12-31Not applicableCanada
Engerix-BInjection, suspension20 ug/1mLIntramuscularDispensing Solutions, Inc.2009-05-28Not applicableUs
Engerix-BInjection, suspension10 ug/0.5mLIntramuscularA-S Medication Solutions2007-04-25Not applicableUs
Engerix-BInjection, suspension20 ug/1mLIntramuscularGlaxoSmithKline Biologicals SA2007-03-28Not applicableUs
Engerix-BInjection, suspension20 ug/1mLIntramuscularA-S Medication Solutions2007-03-28Not applicableUs
Engerix-BInjection, suspension10 ug/0.5mLIntramuscularGlaxoSmithKline Biologicals SA2007-04-25Not applicableUs
Engerix-BInjection, suspension20 ug/1mLIntramuscularPhysicians Total Care, Inc.2002-08-052012-06-30Us
Engerix-B (pediatric Dose)Suspension10 mcgIntramuscularGlaxosmithkline Inc2008-07-25Not applicableCanada
Heplisav-BInjection, solution20 ug/0.5mLIntramuscularDynavax Technologies Corporation2018-01-01Not applicableUs
Heplisav-BInjection, solution20 ug/0.5mLIntramuscularA-S Medication Solutions2018-01-01Not applicableUs
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
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
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
TwinrixHepatitis B Vaccine (Recombinant) (20 mcg) + Hepatitis A Vaccine (720 unit)SuspensionIntramuscularGlaxosmithkline Inc1997-09-23Not applicableCanada
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
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
Twinrix JuniorHepatitis B Vaccine (Recombinant) (10 mcg) + Hepatitis A Vaccine (360 unit)SuspensionIntramuscularGlaxosmithkline Inc1998-11-06Not applicableCanada
Categories
UNII
IFJ010MNE4
CAS number
Not Available

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.
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.

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
DrugInteraction
2-MethoxyethanolThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with 2-Methoxyethanol.
6-Deoxyerythronolide BThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with 6-Deoxyerythronolide B.
9-(N-methyl-L-isoleucine)-cyclosporin AThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with 9-(N-methyl-L-isoleucine)-cyclosporin A.
AbataceptThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Abatacept.
AbetimusThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Abetimus.
Acetyl sulfisoxazoleThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Acetyl sulfisoxazole.
ActeosideThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Acteoside.
AdalimumabThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Adalimumab.
AfelimomabThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Afelimomab.
AldesleukinThe therapeutic efficacy of Hepatitis B Vaccine (Recombinant) can be decreased when used in combination with Aldesleukin.
Food Interactions
Not Available

References

General References
  1. Engerix-B Monograph [Link]
External Links
PubChem Substance
347911220
Drugs.com
Drugs.com Drug Page
Wikipedia
Hepatitis_B_vaccine
AHFS Codes
  • 80:12.00 — Vaccines

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1Active Not RecruitingPreventionExposure to Hepatitis B Virus1
1Active Not RecruitingPreventionHealthy Volunteers1
1CompletedPreventionDiseases Caused by Streptococcus Pneumoniae and Nontypable Haemophilus Influenzae / Haemophilus Influenzae / Haemophilus Influenzae-Streptococcus Pneumoniae Vaccine / Streptococcus Pneumoniae1
1CompletedPreventionHookworm Disease / Hookworm Infection1
1CompletedPreventionHuman Immunodeficiency Virus (HIV) Infections1
1CompletedPreventionInflammatory Bowel Diseases (IBD)1
1CompletedPreventionViral Hepatitis B3
1CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections1
1RecruitingPreventionHookworm Disease / Hookworm Infection1
1Unknown StatusPreventionHuman Immunodeficiency Virus (HIV) Infections1
1Unknown StatusPreventionPlasmodium Infections2
1Unknown StatusTreatmentHepatitis B Chronic Infection1
2CompletedPreventionBacterial Infections; Virus Diseases1
2CompletedPreventionCervical Cancers / Cervical Intraepithelial Neoplasia (CIN)1
2CompletedPreventionDiphtheria / Haemophilus Influenzae Type b (Hib) / Pertussis / Poliomyelitis / Tetanus / Viral Hepatitis B1
2CompletedPreventionDiphtheria / Pertussis / Poliomyelitis / Tetanus / Viral Hepatitis B1
2CompletedPreventionHepatocellular,Carcinoma / Viral Hepatitis B1
2CompletedPreventionMeningitis / Meningococcal Infections1
2CompletedPreventionPlasmodium Infections4
2CompletedPreventionPrevention of Meningococcal Disease1
2CompletedPreventionViral Hepatitis B8
2CompletedTreatmentBipolar Disorder (BD) / Depression / Human Immunodeficiency Virus (HIV) Infections / Schizoaffective Disorders / Schizophrenic Disorders / Substance Abuse1
2RecruitingPreventionHepatitis / Safety and Tolerability1
2TerminatedTreatmentBladder Cancers / Cancer, Breast / Malignant Neoplasm of Colon1
3Active Not RecruitingPreventionHepatitis E1
3CompletedPreventionAcellular Pertussis / Diphtheria / Haemophilus Influenzae Type B / Poliomyelitis / Tetanus / Viral Hepatitis B1
3CompletedPreventionChronic Kidney Disease (CKD)1
3CompletedPreventionDiphtheria / Haemophilus Influenzae Type B Infection / Pertussis / Poliomyelitis / Tetanus / Viral Hepatitis B1
3CompletedPreventionDiphtheria / Pertussis / Poliomyelitis / Viral Hepatitis B1
3CompletedPreventionEnd Stage Renal Disease (ESRD)1
3CompletedPreventionHaemophilus Influenzae Infections / Pneumococcal Diseases / Streptococcal Infections / Streptococcus Pneumoniae1
3CompletedPreventionHaemophilus Influenzae Type B1
3CompletedPreventionHaemophilus Influenzae Type B / Haemophilus Influenzae Type b Diseases / Meningococcal Serogroup C Diseases / Neisseria Meningitidis1
3CompletedPreventionHealthy Volunteers2
3CompletedPreventionHealthy Volunteers / Infants / Viral Hepatitis B1
3CompletedPreventionHepatitis B Virus Infection1
3CompletedPreventionPneumonia & AOM Caused by S. Pneumoniae & H. Influenzae / Streptococcal Infections1
3CompletedPreventionStreptococcal Infections1
3CompletedPreventionViral Hepatitis B21
3CompletedPreventionViral Hepatitis B / Virus Diseases1
3Not Yet RecruitingPreventionHealthy Volunteers (Meningococcal Infection)1
3RecruitingPreventionHealthy Volunteers (Meningococcal Infection)2
3RecruitingPreventionInfections, Pneumococcal1
3RecruitingPreventionMeningococcal Infections1
3RecruitingPreventionVenereal Warts1
4Active Not RecruitingBasic ScienceImmunization; Infection / Viral Hepatitis B1
4Active Not RecruitingPreventionHIV/AIDS and Infections1
4CompletedNot AvailableHepatitis1
4CompletedNot AvailableProphylaxis Hepatitis B / Viral Hepatitis B1
4CompletedBasic ScienceViral Hepatitis B1
4CompletedPreventionHepatitis1
4CompletedPreventionHepatitis A / Viral Hepatitis B4
4CompletedPreventionHepatitis A / Viral Hepatitis B / Viral Hepatitis Vaccines1
4CompletedPreventionHepatitis B Vaccine1
4CompletedPreventionHepatitis B Vaccine / Viral Hepatitis B1
4CompletedPreventionHuman Immunodeficiency Virus (HIV) Infections / Viral Hepatitis B1
4CompletedPreventionImmune Response / Seroprevalence / Viral Hepatitis B1
4CompletedPreventionPapillomavirus Infections1
4CompletedPreventionPeritoneal dialysis therapy / Renal Disease, End-Stage1
4CompletedPreventionVaccination / Viral Hepatitis B1
4CompletedPreventionViral Hepatitis B9
4CompletedTreatmentHepatitis B Chronic Infection1
4Enrolling by InvitationTreatmentHepatitis B Chronic Infection1
4RecruitingBasic ScienceHepatitis C Infection1
4RecruitingPreventionApnea / Apnoea neonatal / Infants, Premature1
4RecruitingPreventionVertical Transmission of Infectious Disease / Viral Hepatitis B1
4TerminatedPreventionHuman Papillomavirus Infections1
4Unknown StatusPreventionHealthy Volunteers1
4Unknown StatusPreventionViral Hepatitis B3
Not AvailableCompletedNot AvailableChronic Kidney Disease (CKD)1
Not AvailableCompletedNot AvailableHealthy Volunteers1
Not AvailableCompletedNot AvailableViral Hepatitis B1
Not AvailableCompletedBasic ScienceInnate Immune Response1
Not AvailableCompletedBasic ScienceViral Hepatitis B1
Not AvailableCompletedPreventionHepatitis A / Hepatitis C Viral Infection / Medication Adherence / Risk Behaviors / Substance Abuse, Intravenous / Viral Hepatitis B1
Not AvailableCompletedPreventionHuman Immunodeficiency Virus (HIV) Infections / Infections, Pneumococcal / Pertussis / Rubeola / Viral Hepatitis B1
Not AvailableCompletedPreventionVaccination; Complications, Reaction, Serum1
Not AvailableCompletedPreventionViral Hepatitis B1
Not AvailableCompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections3
Not AvailableRecruitingNot AvailableInflammatory Bowel Diseases (IBD)1
Not AvailableRecruitingNot AvailableNon-Alcoholic Fatty Liver Disease (NAFLD) / Vaccine Reaction / Viral Hepatitis B1
Not AvailableRecruitingNot AvailablePregnant State1
Not AvailableRecruitingBasic ScienceNewborn Vaccine Immunogenicity1
Not AvailableTerminatedTreatmentGluten Enteropathy1
Not AvailableUnknown StatusPreventionInflammatory Bowel Diseases (IBD)1
Not AvailableUnknown StatusPreventionVaccines / Viral Hepatitis B1
Not AvailableWithdrawnPreventionHealthy, no Evidence of Disease1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Injection, suspensionIntramuscular
SuspensionIntramuscular20 mcg
Injection, suspensionIntramuscular10 ug/0.5mL
Injection, suspensionIntramuscular20 ug/1mL
SuspensionIntramuscular10 mcg
Injection, solutionIntramuscular20 ug/0.5mL
Injection, suspensionIntramuscular10 ug/1mL
Injection, suspensionIntramuscular; Subcutaneous10 ug/1mL
Injection, suspensionIntramuscular; Subcutaneous40 ug/1mL
Injection, suspensionIntramuscular; Subcutaneous5 ug/0.5mL
SolutionIntramuscular40 mcg
SolutionIntramuscular10 mcg
SuspensionIntramuscular
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

Classification
Not classified

Drug created on October 17, 2016 15:25 / Updated on December 10, 2018 13:39