A database of FDA approved therapeutic peptides and proteins
Details of Th1229 which contains 2 entries. |
| Entry 1 | |
| (1) Primary information | |
|---|---|
| ID | 1840 |
| ThPP ID | Th1229 |
| Therapeutic Peptide/Protein Name | Hepatitis A Vaccine |
| Sequence | NA view full sequnce in fasta |
| Functional Classification | IIIa |
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting Point (℃) | NA |
| Half Life | Evaluation of pharmacokinetic properties is not required for vaccines. |
| Description | Two 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/Disease | Hepatitis 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. |
| Pharmacodynamics | Elevation of Anti-Hepatitis A antibodies which gives protection against Hepatitis A infection. |
| Mechanism of Action | The 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. |
| Toxicity | Health injuries are not known or expected under normal use. LD50 |
| Metabolism | |
| Absorption | Vaccine is intended for intramuscular injection. Evaluation of pharmacokinetic properties is not required for vaccines. |
| Volume of Distribution | Evaluation of pharmacokinetic properties is not required for vaccines. |
| Clearance | Evaluation of pharmacokinetic properties is not required for vaccines. |
| Categories | Vaccine |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Information of corresponding available drug in the market | |
| Brand Name | Avaxim |
| Company | Sanofi Pasteur Limited |
| Brand Discription | Avaxim contains inactivated hepatitis A virus that is not capable of causing disease, but instead stimulates your body to produce its own protection (antibodies) against the disease. Protection against hepatitis A is usually in place within one month of injection. |
| Prescribed for | AVAXIM is indicated for active immunisation against infection caused by hepatitis A virus in susceptible adults and adolescents of 16 years of age and above. |
| Chemical Name | NA |
| Formulation | Each 0.5 mL dose of sterile, whitish, cloudy suspension, contains 80 antigen units of inactivated hepatitis A virus. Nonmedicinal ingredients: aluminum hydroxide (expressed as aluminum): 0.15 mg; 2-phenoxyethanol: 2.5 µL; formaldehyde: 12.5 µg; polysorbate 80 in less than 750 µg; medium 199, water for injection up to: 0.5 mL; neomycin: trace amounts. |
| Physcial Appearance | Suspension |
| Route of Administration | Intramuscular |
| Recommended Dosage | NA |
| Contraindication | Hypersensitivity to the active substance(s) or to any of the excipients. |
| Side Effects | diarrhea, drowsiness, fatigue, fever, generally feeling unwell, headache, irritability, loss of appetite, muscle or joint achiness, nausea or vomiting, pain and redness at the injection site, swelling or hard lump at the injection site, weakness might occur as side reaction |
| Useful Link | https://www.medicines.org.uk/emc/medicine/6206, http://www.netdoctor.co.uk/medicines/infections/a7882/hepatitis-a-vaccine/, http://chealth.canoe.com/drug/getdrug/avaxim |
| PubMed ID | 28319454, 28183000, 27942197 |
| 3-D Structure | N.A. |
| Entry 2 | |
| (2) Primary information | |
|---|---|
| ID | 1841 |
| ThPP ID | Th1229 |
| Therapeutic Peptide/Protein Name | Hepatitis A Vaccine |
| Sequence | NA view full sequnce in fasta |
| Functional Classification | IIIa |
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting Point (℃) | NA |
| Half Life | Evaluation of pharmacokinetic properties is not required for vaccines. |
| Description | Two 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/Disease | Hepatitis 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. |
| Pharmacodynamics | Elevation of Anti-Hepatitis A antibodies which gives protection against Hepatitis A infection. |
| Mechanism of Action | The 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. |
| Toxicity | Health injuries are not known or expected under normal use. LD51 |
| Metabolism | |
| Absorption | Vaccine is intended for intramuscular injection. Evaluation of pharmacokinetic properties is not required for vaccines. |
| Volume of Distribution | Evaluation of pharmacokinetic properties is not required for vaccines. |
| Clearance | Evaluation of pharmacokinetic properties is not required for vaccines. |
| Categories | Vaccine |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Information of corresponding available drug in the market | |
| Brand Name | Havrix |
| Company | Dispensing Solutions, Inc. |
| Brand Discription | HAVRIX (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 for | HAVRIX® is indicated for active immunization against disease caused by hepatitis A virus (HAV) |
| Chemical Name | NA |
| Formulation | Each 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 Appearance | Suspension |
| Route of Administration | Intramuscular |
| Recommended Dosage | Primary 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. |
| Contraindication | Severe 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 Effects | Injection site hematoma, upper respiratory tract infections, Insomnia etc |
| Useful Link | http://www.rxlist.com/havrix-drug.htm |
| PubMed ID | 28319454, 28183000, 27942198 |
| 3-D Structure | N.A. |