Identification

Name
Hepatitis A Vaccine
Accession Number
DB10989  (DB10309)
Type
Biotech
Groups
Approved
Biologic Classification
Vaccines
Other vaccines
Description

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

Synonyms
  • Hepatitis A vaccine, inactivated
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
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
AvaximSuspensionIntramuscularSanofi Pasteur Limited1999-05-27Not applicableCanada
Avaxim - Pediatric -(5ml Vial)SuspensionIntramuscularSanofi Pasteur LimitedNot applicableNot applicableCanada
Avaxim - Pediatric -(syringe)SuspensionIntramuscularSanofi Pasteur Limited2003-04-09Not applicableCanada
EpaxalLiquidIntramuscularBerna Biotech Ltd2000-01-112015-01-01Canada
HavrixInjection, suspension1440 [iU]/1mLIntramuscularDispensing Solutions, Inc.2007-04-13Not applicableUs
HavrixInjection, suspension1440 [iU]/1mLIntramuscularDispensing Solutions, Inc.2007-04-13Not applicableUs
HavrixInjection, suspension720 [iU]/0.5mLIntramuscularGlaxoSmithKline Biologicals SA2007-02-16Not applicableUs
HavrixInjection, suspension1440 [iU]/1mLIntramuscularA-S Medication Solutions2007-04-13Not applicableUs
HavrixInjection, suspension1440 [iU]/1mLIntramuscularGlaxoSmithKline Biologicals SA2007-04-13Not applicableUs
Havrix - 720unit/ml SusSuspensionIntramuscularGlaxosmithkline Inc1994-12-312001-10-03Canada
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 End
TwinrixHepatitis A Vaccine (720 unit) + Hepatitis B Vaccine (Recombinant) (20 mcg)SuspensionIntramuscularGlaxosmithkline Inc1997-09-23Not applicableCanada
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
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
Twinrix JuniorHepatitis A Vaccine (360 unit) + Hepatitis B Vaccine (Recombinant) (10 mcg)SuspensionIntramuscularGlaxosmithkline Inc1998-11-06Not applicableCanada
VivaximHepatitis A Vaccine (160 unit) + Typhoid Vi polysaccharide vaccine (25 mcg)Solution; SuspensionIntramuscularSanofi Pasteur Limited2005-11-09Not applicableCanada
Categories
UNII
Not Available
CAS number
Not Available

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

Associated Conditions
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
Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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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
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

Affected organisms
Not Available
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
2-MethoxyethanolThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with 2-Methoxyethanol.
9-(N-methyl-L-isoleucine)-cyclosporin AThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with 9-(N-methyl-L-isoleucine)-cyclosporin A.
AbataceptThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Abatacept.
AbetimusThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Abetimus.
ActeosideThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Acteoside.
AdalimumabThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Adalimumab.
AfelimomabThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Afelimomab.
AlclometasoneThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Alclometasone.
AldesleukinThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Aldesleukin.
AldosteroneThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Aldosterone.
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.

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. [PubMed:18159360]
  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. [PubMed:12744850]
  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]
External Links
PubChem Substance
347911071
RxNav
253174
Drugs.com
Drugs.com Drug Page
AHFS Codes
  • 80:12.00 — Vaccines

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1Active Not RecruitingPreventionHealthy Volunteers1
1CompletedBasic ScienceHealthy Volunteers1
1CompletedPreventionHepatitis C Viral Infection / Human Immunodeficiency Virus (HIV) Infections1
1CompletedPreventionPlasmodium Infections1
1CompletedPreventionRespiratory Synctial Virus1
2Active Not RecruitingPreventionPlasmodium Infections1
2Active Not RecruitingPreventionVaccine Response Impaired1
2CompletedOtherMeningococcal Disease / Meningococcal Infections1
2CompletedPreventionDengue Diseases / Dengue Fever / Dengue Hemorrhagic Fever / Dengue Virus1
2CompletedPreventionDengue Fever / Dengue Hemorrhagic Fever1
2CompletedPreventionDiseases Caused by Measles, Mumps, Rubella and Varicella Viruses / Measles-Mumps-Rubella-Varicella Vaccine / Mumps / Rubella / Rubeola / Varicella1
2CompletedPreventionEncephalitis, Japanese B / Hepatitis A1
2CompletedPreventionHealthy Volunteers / Norovirus / Norovirus, Prevention1
2CompletedPreventionHepatitis A1
2CompletedPreventionMeasles-Mumps-Rubella Vaccine / Mumps / Rubella / Rubeola1
2CompletedPreventionMeningococcal Infections1
2CompletedPreventionResponse to Hepatitis A Vaccine1
2CompletedPreventionStreptococcal Infections / Streptococcus Pneumoniae and Nontypable Haemophilus Influenzae / Streptococcus Pneumoniae Vaccines1
2CompletedPreventionViral Hepatitis B1
2CompletedTreatmentBipolar Disorder (BD) / Depression / Human Immunodeficiency Virus (HIV) Infections / Schizoaffective Disorders / Schizophrenia / Substance Abuse1
2CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections1
2TerminatedBasic ScienceTransplant-Related Cancer1
2TerminatedTreatmentBreast Cancer / Cancer, Bladder / Malignant Neoplasm of Colon1
2, 3TerminatedPreventionInfections, Cytomegalovirus1
2, 3Unknown StatusPreventionHepatitis A / Varicella1
3Active Not RecruitingPreventionHepatitis A Vaccine1
3Active Not RecruitingPreventionInfections, Pneumococcal / Vaccines, Pneumococcal1
3CompletedPreventionCervical Cancers / Precancerous Conditions1
3CompletedPreventionCervical Intraepithelial Neoplasia (CIN) / Papillomavirus Infection1
3CompletedPreventionEncephalitis, Japanese B1
3CompletedPreventionEncephalitis, Japanese B / Hepatitis A1
3CompletedPreventionFlu caused by Influenza3
3CompletedPreventionHaemophilus Influenzae Infections / Pneumococcal Diseases / Streptococcal Infections / Streptococcus Pneumoniae1
3CompletedPreventionHaemophilus Influenzae Type B / Neisseria Meningitidis1
3CompletedPreventionHepatitis A4
3CompletedPreventionHepatitis A Vaccine1
3CompletedPreventionHepatitis A Virus Infection1
3CompletedPreventionHepatitis A / Hepatitis A Vaccine1
3CompletedPreventionHepatitis A / Meningococcal Disease / Meningococcal Meningitis / Viral Hepatitis B1
3CompletedPreventionHepatitis A / Salmonella Typhi Infection / Viral Hepatitis B1
3CompletedPreventionHepatitis A / Viral Hepatitis B5
3CompletedPreventionHerpes Simplex1
3CompletedPreventionHerpes Simplex Infection1
3CompletedPreventionHuman Papillomavirus (HPV) Infection / Papillomavirus Infections / Papillomavirus Vaccines1
3CompletedPreventionInflammation, Brain1
3CompletedPreventionMeasles; Mumps; Rubella1
3CompletedPreventionMeningococcal Infections / Meningococcal Serogroup A, C, W-135, Y Diseases1
3CompletedPreventionMeningococcal Meningitis1
3CompletedPreventionMeningococcal Vaccines1
3CompletedPreventionMumps / Rubella / Rubeola2
3CompletedPreventionPapillomavirus Infections1
3CompletedPreventionPneumonia & AOM Caused by S. Pneumoniae & H. Influenzae / Streptococcal Infections1
3CompletedPreventionStreptococcal Infections1
3CompletedPreventionStreptococcal Infections / Streptococcus Pneumoniae Vaccines1
3CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections1
3RecruitingPreventionMeningococcal Infections1
3RecruitingPreventionViral Hepatitis B1
3Unknown StatusPreventionHepatitis A / Human Immunodeficiency Virus (HIV) Infections / Viral Hepatitis B1
3WithdrawnBasic ScienceHuman Immunodeficiency Virus (HIV) Infections1
3WithdrawnPreventionPapillomavirus Infections1
4Active Not RecruitingBasic ScienceFlu caused by Influenza / Healthy Adults / Hepatitis A / Salmonella Typhi Infection1
4Active Not RecruitingPreventionHepatitis A / Rubeola / Varicella1
4Active Not RecruitingPreventionPneumonia, Pneumococcal1
4CompletedOtherMeningococcal Serogroup B1
4CompletedPreventionChickenpox / Hepatitis A / Mumps / Rubella / Rubeola1
4CompletedPreventionCrohn's Disease (CD) / Hepatitis A / Inflammatory Bowel Diseases (IBD) / Ulcerative Colitis1
4CompletedPreventionFlu caused by Influenza1
4CompletedPreventionFlu caused by Influenza / Influenza Infection2
4CompletedPreventionHepatitis A8
4CompletedPreventionHepatitis A Virus2
4CompletedPreventionHepatitis A / Hepatitis A Virus1
4CompletedPreventionHepatitis A / Mumps / Rubella / Rubeola1
4CompletedPreventionHepatitis A / Viral Hepatitis B5
4CompletedPreventionHepatitis A / Viral Hepatitis B / Viral Hepatitis Vaccines1
4CompletedPreventionHuman Immunodeficiency Virus (HIV) Infections1
4CompletedPreventionHuman Immunodeficiency Virus (HIV) Infections / Viral Hepatitis B1
4CompletedPreventionInflammation, Brain1
4CompletedPreventionParatyphoid Fever / Salmonella Typhi Infection2
4CompletedPreventionViral Hepatitis B1
4Enrolling by InvitationPreventionHepatitis A1
4RecruitingPreventionHepatitis A / Human Immunodeficiency Virus (HIV) Infections / Vaccine Response Impaired1
4RecruitingPreventionHuman Papillomavirus Infections1
4TerminatedPreventionAcellular Pertussis / Diphtheria / Hepatitis A / Pertussis / Tetanus1
4Unknown StatusPreventionAntibody Response After Vaccination1
4Unknown StatusPreventionMeasurement of Immune Response to Hepatitis A / Measurement of Immune Response to Prevenar131
4Unknown StatusPreventionViral Hepatitis B2
4WithdrawnPreventionHepatitis A1
Not AvailableActive Not RecruitingNot AvailableAstrocytomas / Gliomas / Oligodendrogliomas1
Not AvailableActive Not RecruitingNot AvailableInfections, Pneumococcal1
Not AvailableCompletedNot AvailableRheumatoid Arthritis / Spondylarthritis / Vasculitis1
Not AvailableCompletedPreventionHepatitis1
Not AvailableCompletedPreventionHepatitis A1
Not AvailableCompletedPreventionHepatitis A / Hepatitis C Viral Infection / Medication Adherence / Risk Behaviors / Substance Abuse, Intravenous / Viral Hepatitis B1
Not AvailableCompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections4
Not AvailableEnrolling by InvitationPreventionCystic Fibrosis (CF) / Hepatitis A / Tuberculosis Infection / Viral Hepatitis B1
Not AvailableRecruitingPreventionAutoimmune Rheumatologic Disease1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
LiquidIntramuscular
Injection, suspensionIntramuscular1440 [iU]/1mL
Injection, suspensionIntramuscular720 [iU]/0.5mL
SuspensionIntramuscular
Injection, suspensionIntramuscular
SuspensionIntramuscular
Injection, suspensionIntramuscular25 [iU]/0.5mL
Injection, suspensionIntramuscular50 [iU]/1mL
SuspensionIntramuscular50 unit
Solution; suspensionIntramuscular
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Taxonomy

Classification
Not classified

Targets

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 on December 01, 2015 13:04 / Updated on May 25, 2020 23:44

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