==== Reference: Usmani SS, Bedi G, Samuel JS, Singh S, Kalra S, Kumar P, et al. (2017) THPdb: Database of FDA-approved peptide and protein therapeutics. PLoS ONE 12(7) e0181748.====

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1841 details
Primary information
ThPP IDTh1229
Therapeutic Peptide/Protein NameHepatitis A Vaccine
SequenceNA view full sequnce in fasta
Functional ClassificationIIIa
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting Point (℃)NA
Half LifeEvaluation of pharmacokinetic properties is not required for vaccines.
DescriptionTwo types of HAV vaccines are currently available internationally: 1. Formaldehyde-inactivated vaccines: Inactivated HAV vaccines are used in most countries. Monovalent inactivated HAV vaccines are available in paediatric dose (0.5 ml) for children aged 1 year to 15 years, and in adult dose (1 ml). 2. Live attenuated vaccines (based on H2 or LA-1 HAV strains): These vaccines are manufactured and used mainly in China and India. Inactivated hepatitis A vaccines are safe and highly effective. Traditionally, a two-dose schedule is recommended, particularly in travellers at substantial risk of contracting hepatitis A and in immunocompromised individuals. However, in healthy individuals, comparable effectiveness has been achieved with a single dose. The Chinese live attenuated hepatitis A vaccines have been shown to be safe and highly protective (95%) against clinical infection for at least 3 years. Among the adverse effects from Hepatitis A vaccine injection are fatigue, fever > 99.5°F (37.5°C), induration, redness, and swelling of the injection site and malaise. Anorexia and nausea could be possible side effects.
Indication/DiseaseHepatitis A vaccine is indicated for active immunization against disease caused by hepatitis A virus (HAV). It is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. HAVRIX® will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low to intermediate prevalence of hepatitis A, immunization with HAVRIX® is particularly recommended in subjects who are, or will be, at increased risk of infection such as: * Travelers: Persons traveling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the Mediterranean basin, the Middle East, Central and South America. * Armed Forces: Armed Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor have an increased risk of HAV infection. Active immunization is indicated for these individuals. * Persons for whom Hepatitis A is an Occupational Hazard: These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and pediatric units, sewage workers, and food handlers, among others. * Persons for whom there is an Increased Risk of Transmission of Hepatitis A: e.g. homosexuals, persons with multiple sexual partners, abusers of injectable drugs, hemophiliac patients. * Contacts of Infected Persons: Since virus shedding of infected persons may occur for a prolonged period, active immunization of close contacts is recommended. * Specific Population Groups known to have Higher Incidence of Hepatitis A: e.g. North American Indians, Inuits, recognized community-wide HAV epidemics. * Subjects with chronic liver disease or who are at risk of developing chronic liver disease e.g. Hepatitis B (HB) and Hepatitis C (HC) chronic carriers and alcohol abusers.
PharmacodynamicsElevation of Anti-Hepatitis A antibodies which gives protection against Hepatitis A infection.
Mechanism of ActionThe hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined.
ToxicityHealth injuries are not known or expected under normal use. LD51
Metabolism
AbsorptionVaccine is intended for intramuscular injection. Evaluation of pharmacokinetic properties is not required for vaccines.
Volume of DistributionEvaluation of pharmacokinetic properties is not required for vaccines.
ClearanceEvaluation of pharmacokinetic properties is not required for vaccines.
CategoriesVaccine
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetNA
Information of corresponding available drug in the market
Brand NameHavrix
CompanyDispensing Solutions, Inc.
Brand DiscriptionHAVRIX (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration. The virus (strain HM175) is propagated in MRC-5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.).
Prescribed forHAVRIX® is indicated for active immunization against disease caused by hepatitis A virus (HAV)
Chemical NameNA
FormulationEach 1-mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. It contains few excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL).
Physcial AppearnceSuspension
Route of AdministrationIntramuscular
Recommended DosagePrimary immunization for children and adolescents (12 months through 18 years of age) consists of a single 0.5-mL dose and a 0.5-mL booster dose administered anytime between 6 and 12 months later.
ContraindicationSevere allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX
Side EffectsInjection site hematoma, upper respiratory tract infections, Insomnia etc
Useful Linkhttp://www.rxlist.com/havrix-drug.htm
PubMed ID28319454, 28183000, 27942198
3-D StructureN.A.