Hepatitis A Vaccine
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Identification
- Summary
Hepatitis A Vaccine is an inactivated 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
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used in combination to prevent Hepatitis a •••••••• ••• ••••••••• •••••••••• Used in combination to prevent Hepatitis a Combination Product in combination with: Typhoid Vi polysaccharide vaccine (DB10803) •••••••••••• ••••••••• Prevention of Hepatitis a •••••••••••• •••••••••• •••••••••• Used in combination to prevent Salmonella typhi infection Combination Product in combination with: Typhoid Vi polysaccharide vaccine (DB10803) •••••••••••• ••••••••• - Contraindications & Blackbox Warnings
- Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API
- 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
Target Actions Organism 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
- Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.
- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbatacept The therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Abatacept. Adalimumab The therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Adalimumab. Aldesleukin The therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Aldesleukin. Alefacept The therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Alefacept. Alemtuzumab The therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Alemtuzumab. - Food Interactions
- No interactions found.
Products
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- Product Ingredients
Ingredient UNII CAS InChI Key Hepatitis A virus strain CR 326F antigen (formaldehyde inactivated) Q04Q922K9Q Not Available Not applicable Hepatitis A virus strain HM175 antigen (formaldehyde inactivated) 5BFC8LZ6LQ Not Available Not applicable - Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Avaxim Suspension 160 unit / 0.5 mL Intramuscular Sanofi Pasteur Limited 1999-05-27 Not applicable Canada Avaxim - Pediatric Suspension 80 unit / 0.5 mL Intramuscular Sanofi Pasteur Limited 2003-04-09 2022-06-08 Canada Avaxim - Pediatric -(5ml Vial) Suspension 800 unit / 5 mL Intramuscular Sanofi Pasteur Limited Not applicable Not applicable Canada Epaxal Liquid 500 unit / 0.5 mL Intramuscular Berna Biotech Ltd 2000-01-11 2015-01-01 Canada Havrix Injection, suspension 720 [iU]/0.5mL Intramuscular GlaxoSmithKline Biologicals SA 2007-02-16 Not applicable US - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Ambirix Hepatitis A Vaccine (720 ELISA Units) + Hepatitis B Vaccine (Recombinant) (20 mcg) Injection, suspension Intramuscular Glaxo Smith Kline Biologicals S.A. 2021-03-18 Not applicable EU Ambirix Hepatitis A Vaccine (720 ELISA Units) + Hepatitis B Vaccine (Recombinant) (20 mcg) Injection, suspension Intramuscular Glaxo Smith Kline Biologicals S.A. 2021-03-18 Not applicable EU Ambirix Hepatitis A Vaccine (720 ELISA Units) + Hepatitis B Vaccine (Recombinant) (20 mcg) Injection, suspension Intramuscular Glaxo Smith Kline Biologicals S.A. 2021-03-18 Not applicable EU Ambirix Hepatitis A Vaccine (720 ELISA Units) + Hepatitis B Vaccine (Recombinant) (20 mcg) Injection, suspension Intramuscular Glaxo Smith Kline Biologicals S.A. 2021-03-18 Not applicable EU Ambirix Hepatitis A Vaccine (720 ELISA Units) + Hepatitis B Vaccine (Recombinant) (20 mcg) Injection, suspension Intramuscular Glaxo Smith Kline Biologicals S.A. 2021-03-18 Not applicable EU
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Not Available
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
- 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]
- 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]
- MSDS [Link]
- WHO website [Link]
- product info [Link]
- Havrix Monograph [Link]
- FDA approved vaccines: Havrix (Hepatitis A) intramuscular injection [Link]
- WHO: Vaccine immunology [Link]
- GSK: Twinrix adult MSDS [Link]
- NIH StatPearls: Hepatitis A Vaccine [Link]
- Health Canada Product Monograph: Vivaxim (Combined Purified Vi Polysaccharide Typhoid and Inactivated Hepatitis A Vaccine) for intramuscular administration [Link]
- External Links
- PubChem Substance
- 347911071
- 253174
- Drugs.com
- Drugs.com Drug Page
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Completed Not Available Astrocytoma / Glioma / Oligodendroglioma 1 somestatus stop reason just information to hide Not Available Completed Not Available Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD / Vaccine Reaction / Viral Hepatitis B 1 somestatus stop reason just information to hide Not Available Completed Not Available Pneumococcal Infection 1 somestatus stop reason just information to hide Not Available Completed Not Available Rheumatoid Arthritis / Spondylarthritis / Vasculitis 1 somestatus stop reason just information to hide Not Available Completed Prevention Adherence, Medication / Hepatitis A / Hepatitis C Virus (HCV) Infection / Risky Behaviors / Substance Abuse, Intravenous / Viral Hepatitis B 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection Intramuscular 160 U/0.5ml Injection, suspension Intramuscular 160 UE Injection, suspension Intramuscular 160 IU Suspension Intramuscular 160 unit / 0.5 mL Suspension Intramuscular 160 UE Suspension Intramuscular 80 unit / 0.5 mL Suspension Intramuscular 800 unit / 5 mL Suspension Intramuscular 160 U/0.5ml Injection Intramuscular 80 EU/0.5ml Injection Intramuscular 80 U/0.5ml Suspension Intramuscular 80 U/0.5ml Injection, suspension Intramuscular 80 U/ml Injection, suspension Intramuscular 80 U/0.5ml Injection, suspension Intramuscular Emulsion Intramuscular Liquid Intramuscular 500 unit / 0.5 mL Injection, solution Intramuscular 1440 IU/mL Injection, solution Intramuscular 720 IU/0.5mL Injection, suspension Intramuscular 1440 [iU]/1mL Injection, suspension Intramuscular 1440 IU/mL Injection, suspension Intramuscular 1441 IU/mL Injection, suspension Intramuscular 1442 IU/mL Injection, suspension Intramuscular 1443 IU/mL Injection, suspension Intramuscular 1444 IU/mL Injection, suspension Intramuscular 1445 IU/mL Injection, suspension Intramuscular 720 [iU]/0.5mL Suspension Intramuscular 720 unit / mL Suspension Intramuscular 1440 unit / mL Injection, suspension Intramuscular 1440 ElU/ml Injection, suspension Parenteral 0.5 ml Injection Intramuscular 1440 EL.U./1ml Injection, suspension Intramuscular 1440 units Injection Intramuscular 1440 elisa units/ml Suspension Intramuscular 720 unit / 0.5 mL Injection, suspension Intramuscular 720 units Injection Intramuscular 1440 EU Injection Intramuscular 720 elisa units/0.5ml Injection Intramuscular 720 EU Injection, suspension 500 IU/ml Injection, solution Intramuscular Injection Intramuscular 12 U Injection Intramuscular Injection, suspension Intramuscular Suspension Intramuscular Injection, suspension Intramuscular 25 U Injection, suspension Intramuscular 25 [iU]/0.5mL Injection, suspension Intramuscular 50 [iU]/1mL Suspension Intramuscular 50 unit / mL Suspension Intramuscular 50 U Suspension Intramuscular 25 U Injection, suspension Parenteral 50 E./1ml Injection, suspension Parenteral 25 E./0.5ml Injection Intramuscular 25 u/0.5ml Injection Intramuscular 50 U/ml Injection, suspension Intramuscular 50 U Injection, suspension Intramuscular 0.5 mL Solution; suspension Intramuscular Suspension Intramuscular 160 i.u./0.5 ml Injection Intramuscular 50 U/1ml - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Targets
Drug created at December 01, 2015 20:04 / Updated at September 15, 2024 21:55