Hepatitis A Vaccine

Identification

Name
Hepatitis A Vaccine
Accession Number
DB10989
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

Type
Biotech
Groups
Approved
Biologic Classification
Vaccines
Other vaccines
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

Associated Conditions
Contraindications & Blackbox Warnings
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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
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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
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).
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 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
AvaximSuspensionIntramuscularSanofi Pasteur Limited1999-05-27Not applicableCanada flag
Avaxim - Pediatric -(5ml Vial)SuspensionIntramuscularSanofi Pasteur LimitedNot applicableNot applicableCanada flag
Avaxim - Pediatric -(syringe)SuspensionIntramuscularSanofi Pasteur Limited2003-04-09Not applicableCanada flag
EpaxalLiquidIntramuscularBerna Biotech Ltd2000-01-112015-01-01Canada flag
HavrixInjection, suspension1440 [iU]/1mLIntramuscularDispensing Solutions, Inc.2007-04-13Not applicableUS flag
HavrixInjection, suspension1440 [iU]/1mLIntramuscularGlaxoSmithKline Biologicals SA2007-04-13Not 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 SusSuspensionIntramuscularGlaxosmithkline Inc1994-12-312001-10-03Canada 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
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) + Hepatitis B Vaccine (Recombinant) (20 mcg)SuspensionIntramuscularGlaxosmithkline Inc1997-09-23Not applicableCanada 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 JuniorHepatitis A Vaccine (360 unit) + Hepatitis B Vaccine (Recombinant) (10 mcg)SuspensionIntramuscularGlaxosmithkline Inc1998-11-06Not applicableCanada flag
VivaximHepatitis A Vaccine (160 unit) + Typhoid Vi polysaccharide vaccine (25 mcg)Solution; SuspensionIntramuscularSanofi Pasteur Limited2005-11-09Not applicableCanada flag

Categories

Drug Categories
Classification
Not classified

Chemical Identifiers

UNII
Not Available
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. [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]
PubChem Substance
347911071
RxNav
253174
Drugs.com
Drugs.com Drug Page
AHFS Codes
  • 80:12.00 — Vaccines

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
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

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SuspensionIntramuscular160 U/0.5ml
SuspensionIntramuscular80 U/0.5ml
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
SuspensionIntramuscular50 U
Injection, suspensionIntramuscular50 U
Solution; suspensionIntramuscular
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

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 September 17, 2020 23:29

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