Identification

Summary

Hepatitis A Vaccine is a live attenuated vaccine against infection with the Hepatitis A virus.

Brand Names
Avaxim, Havrix, Twinrix, Vaqta
Generic Name
Hepatitis A Vaccine
DrugBank Accession Number
DB10989
Background

Hepatitis A viral infection can lead to significant morbidity and mortality, with signs and symptoms that include anorexia, nausea, vomiting, and liver failure.1 Known by several trade names, such as Havrix and Twinrix, the Hepatitis A vaccine has been formulated for immunization against hepatitis A virus (HAV) infection and safely confers strong protection against the disease caused by infection with this virus.2,7 In the US, the approved vaccine is inactivated while live Hepatitis A vaccines are currently available in other countries.10

Type
Biotech
Groups
Approved
Biologic Classification
Vaccines
Inactivated
Synonyms
  • Hepatitis A vaccine, inactivated

Pharmacology

Indication

Hepatitis A vaccine is indicated for immunization against hepatitis A virus (HAV) infection in patients aged 12 months and older, and the first dose should be administered at least 2 weeks before expected exposure to the Hepatitis A virus.7

Pharmacology
Reduce drug development failure rates
Build, train, & validate machine-learning models
with evidence-based and structured datasets.
See how
Build, train, & validate predictive machine-learning models with structured datasets.
See how
Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
Avoid life-threatening adverse drug events
Improve clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.
Learn more
Avoid life-threatening adverse drug events & improve clinical decision support.
Learn more
Pharmacodynamics

Hepatitis A vaccine stimulates the immune-mediated production of anti-Hepatitis A antibodies, allowing for protection against Hepatitis A infection via the production of specific antibodies against the virus and other immune cells that prevent infection with Hepatitis A virus.6,7

Mechanism of action

The administration of the hepatitis A vaccine leads to immune activation of lymphocytes, which proceed to engulf the hepatitis A antigen, leading to the release of inflammatory mediators that stimulate B and T cells to attack the viral antigen. Following this stimulation, the B cells and T cells then differentiate into memory cells, antibody-producing B cells, cytotoxic T cells, and helper T cells to provide immunity against infection with Hepatitis A.7

TargetActionsOrganism
AB-lymphocytes
inducer
Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
Adverseeffects
Improve decision support & research outcomes
With structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.
Learn more
Improve decision support & research outcomes with our structured adverse effects data.
Learn more
Toxicity

LD50 information for the hepatitis A vaccine is not readily available in the literature. The prescribing information for the inactivated Hepatitis A vaccine indicates that postmarketing reports of adverse effects following an overdose with the vaccine that were similar to those that are normally expected. This may include pain or redness at the injection site, headache, irritability, appetite loss, and other symptoms. Prescribing information also advises contacting the local poison control center in the case of an overdose.6

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 A Vaccine can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Alemtuzumab.
AltretamineThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Altretamine.
AmsacrineThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Amsacrine.
AnakinraThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Anakinra.
Antilymphocyte immunoglobulin (horse)The therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Antilymphocyte immunoglobulin (horse).
Antithymocyte immunoglobulin (rabbit)The therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Antithymocyte immunoglobulin (rabbit).
Interactions
Identify potential medication risks
Easily compare up to 40 drugs with our drug interaction checker.
Get severity rating, description, and management advice.
Learn more
Food Interactions
No interactions found.

Products

Products2
Drug product information from 10+ global regions
Our datasets provide approved product information including:
dosage, form, labeller, route of administration, and marketing period.
Access now
Access drug product information from over 10 global regions.
Access now
Product Ingredients
IngredientUNIICASInChI Key
Hepatitis A virus strain CR 326F antigen (formaldehyde inactivated)Q04Q922K9QNot AvailableNot applicable
Hepatitis A virus strain HM175 antigen (formaldehyde inactivated)5BFC8LZ6LQNot AvailableNot applicable
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
AvaximSuspension160 unit / 0.5 mLIntramuscularSanofi Pasteur Limited1999-05-27Not applicableCanada flag
Avaxim - PediatricSuspension80 unit / 0.5 mLIntramuscularSanofi Pasteur Limited2003-04-09Not applicableCanada flag
Avaxim - Pediatric -(5ml Vial)Suspension800 unit / 5 mLIntramuscularSanofi Pasteur LimitedNot applicableNot applicableCanada flag
EpaxalLiquid500 unit / 0.5 mLIntramuscularBerna Biotech Ltd2000-01-112015-01-01Canada flag
HavrixInjection, suspension1440 [iU]/1mLIntramuscularGlaxoSmithKline Biologicals SA2007-04-13Not applicableUS flag
HavrixInjection, suspension1440 [iU]/1mLIntramuscularDispensing Solutions, Inc.2007-04-13Not applicableUS flag
HavrixInjection, suspension720 [iU]/0.5mLIntramuscularGlaxoSmithKline Biologicals SA2007-02-16Not applicableUS flag
HavrixInjection, suspension1440 [iU]/1mLIntramuscularDispensing Solutions, Inc.2007-04-13Not applicableUS flag
HavrixInjection, suspension1440 [iU]/1mLIntramuscularA-S Medication Solutions2007-04-13Not applicableUS flag
Havrix - 720unit/ml SusSuspension720 unit / mLIntramuscularGlaxosmithkline Inc1994-12-312001-10-03Canada flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
AmbirixHepatitis A Vaccine (720 ELISA Units) + Hepatitis B Vaccine (Recombinant) (20 mcg)Injection, suspensionIntramuscularGlaxo Smith Kline Biologicals S.A.2021-03-18Not applicableEU flag
AmbirixHepatitis A Vaccine (720 ELISA Units) + Hepatitis B Vaccine (Recombinant) (20 mcg)Injection, suspensionIntramuscularGlaxo Smith Kline Biologicals S.A.2021-03-18Not applicableEU flag
AmbirixHepatitis A Vaccine (720 ELISA Units) + Hepatitis B Vaccine (Recombinant) (20 mcg)Injection, suspensionIntramuscularGlaxo Smith Kline Biologicals S.A.2021-03-18Not applicableEU flag
AmbirixHepatitis A Vaccine (720 ELISA Units) + Hepatitis B Vaccine (Recombinant) (20 mcg)Injection, suspensionIntramuscularGlaxo Smith Kline Biologicals S.A.2021-03-18Not applicableEU flag
AmbirixHepatitis A Vaccine (720 ELISA Units) + Hepatitis B Vaccine (Recombinant) (20 mcg)Injection, suspensionIntramuscularGlaxo Smith Kline Biologicals S.A.2021-03-18Not applicableEU flag
TwinrixHepatitis A virus strain HM175 antigen (formaldehyde inactivated) (720 [iU]/1mL) + Hepatitis B virus subtype ADW2 HBSAG surface protein antigen (20 ug/1mL)Injection, suspensionIntramuscularA-S Medication Solutions2007-06-07Not applicableUS flag
TwinrixHepatitis A Vaccine (720 unit / 1.0 mL) + Hepatitis B Vaccine (Recombinant) (20 mcg / 1.0 mL)SuspensionIntramuscularGlaxosmithkline Inc1997-09-23Not applicableCanada flag
TWINRIXHepatitis A Vaccine (720 EL.U./mL) + Hepatitis B Vaccine (Recombinant) (20 mcg/mL)InjectionIntramuscularบริษัท แกล็กโซสมิทไคล์น (ประเทศไทย) จำกัด2005-04-23Not applicableThailand flag
TwinrixHepatitis A virus strain HM175 antigen (formaldehyde inactivated) (720 [iU]/1mL) + Hepatitis B virus subtype ADW2 HBSAG surface protein antigen (20 ug/1mL)Injection, suspensionIntramuscularGlaxoSmithKline Biologicals SA2007-06-07Not applicableUS flag
Twinrix AdultHepatitis A Vaccine (720 ELISA Units/ml) + Hepatitis B Vaccine (Recombinant) (20 mcg/ml)Injection, suspensionIntramuscularGlaxo Smith Kline Biologicals S.A.2021-02-11Not applicableEU flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
G54MT8V18G
CAS number
Not Available

References

Synthesis Reference

Beth Junker John A. Lewis Cynthia Newell Oliver Charles J. Orella Robert D. Sitrin Robert A. Aboud John G. Aunins Barry C. Buckland Peter A. Dephillips Anna J. Hagen John P. Hennessey Jr. Hepatitis A virus vaccine. Patent EP0583142A2. https://patents.google.com/patent/EP0583142A2/en

General References
  1. Wu J, Zou S, Giulivi A: Current hepatitis A status in Canada. Can J Infect Dis. 2001 Nov;12(6):341-4. doi: 10.1155/2001/834670. [Article]
  2. Demicheli V, Tiberti D: The effectiveness and safety of hepatitis A vaccine: a systematic review. Vaccine. 2003 Jun 2;21(19-20):2242-5. doi: 10.1016/s0264-410x(03)00135-x. [Article]
  3. MSDS [Link]
  4. WHO website [Link]
  5. product info [Link]
  6. Havrix Monograph [Link]
  7. FDA approved vaccines: Havrix (Hepatitis A) intramuscular injection [Link]
  8. WHO: Vaccine immunology [Link]
  9. GSK: Twinrix adult MSDS [Link]
  10. NIH StatPearls: Hepatitis A Vaccine [Link]
  11. Health Canada Product Monograph: Vivaxim (Combined Purified Vi Polysaccharide Typhoid and Inactivated Hepatitis A Vaccine) for intramuscular administration [Link]
PubChem Substance
347911071
RxNav
253174
Drugs.com
Drugs.com Drug Page

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingBasic ScienceFlu caused by Influenza / Healthy Adults / Hepatitis A / Salmonella Typhi Infection1
4Active Not RecruitingPreventionHepatitis A / Measles / Varicella1
4CompletedOtherMeningococcal Serogroup B1
4CompletedPreventionChickenpox / Hepatitis A / Measles / Mumps / Rubella1
4CompletedPreventionCrohn's Disease (CD) / Hepatitis A / Inflammatory Bowel Diseases (IBD) / Ulcerative Colitis1
4CompletedPreventionEncephalitis1
4CompletedPreventionFlu caused by Influenza3
4CompletedPreventionHepatitis A8
4CompletedPreventionHepatitis A Virus2
4CompletedPreventionHepatitis A / Hepatitis A Virus1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
InjectionIntramuscular160 U/0.5ml
Injection, suspensionIntramuscular160 IU
Injection, suspensionIntramuscular160 UE
SuspensionIntramuscular160 UE
SuspensionIntramuscular160 unit / 0.5 mL
SuspensionIntramuscular80 unit / 0.5 mL
SuspensionIntramuscular800 unit / 5 mL
SuspensionIntramuscular
InjectionIntramuscular
InjectionIntramuscular80 U/0.5ml
Injection, suspensionIntramuscular80 U/0.5ml
Injection, suspensionIntramuscular
EmulsionIntramuscular
LiquidIntramuscular500 unit / 0.5 mL
Injection, solutionIntramuscular1440 IU/mL
Injection, solutionIntramuscular720 IU/0.5mL
Injection, suspensionIntramuscular1440 IU/mL
Injection, suspensionIntramuscular1440 [iU]/1mL
Injection, suspensionIntramuscular1441 IU/mL
Injection, suspensionIntramuscular1442 IU/mL
Injection, suspensionIntramuscular1443 IU/mL
Injection, suspensionIntramuscular1444 IU/mL
Injection, suspensionIntramuscular1445 IU/mL
Injection, suspensionIntramuscular720 [iU]/0.5mL
SuspensionIntramuscular720 unit / mL
SuspensionIntramuscular1440 unit / mL
Injection, suspensionParenteral
InjectionIntramuscular1440 EL.U./1ml
InjectionIntramuscular1440 elisa units/ml
SuspensionIntramuscular720 unit / 0.5 mL
InjectionIntramuscular720 elisa units/0.5ml
Injection, suspension500 IU/ml
Injection, solutionIntramuscular
InjectionIntramuscular12 U
InjectionIntramuscular
Injection, suspensionIntramuscular
SuspensionIntramuscular
InjectionIntramuscular720 elisa units/ml
InjectionIntramuscular50 U/mL
Injection, suspensionIntramuscular25 U
Injection, suspensionIntramuscular25 [iU]/0.5mL
Injection, suspensionIntramuscular50 [iU]/1mL
SuspensionIntramuscular50 unit / mL
SuspensionIntramuscular50 U
InjectionIntramuscular25 u/0.5ml
Injection, suspensionIntramuscular0.5 mL
Solution; suspensionIntramuscular
SuspensionIntramuscular160 i.u./0.5 ml
InjectionIntramuscular50 U/1ml
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Targets

Drugtargets2
Build, predict & validate machine-learning models
Use our structured and evidence-based datasets to unlock new
insights and accelerate drug research.
Learn more
Use our structured and evidence-based datasets to unlock new insights and accelerate drug research.
Learn more
1. B-lymphocytes
Kind
Group
Organism
Not Available
Pharmacological action
Yes
Actions
Inducer
References
  1. WHO: Vaccine immunology [Link]
  2. NIH StatPearls: Vaccination [Link]
  3. WHO vaccine safety: Hepatitis A vaccine [Link]

Drug created at December 01, 2015 20:04 / Updated at October 26, 2021 21:40