Hepatitis A virus 12092 The virus spreads by the fecal-oral route, and infections often occur in conditions of poor sanitation and overcrowding. HAV enters the bloodstream through the epithelium of the oropharynx or intestine. Once HAV comes to the liver through the blood, it lives and multiplies within hepatocytes and Kupffer cells (i.e., liver macrophages). There is no apparent virus-mediated cytotoxicity, and liver pathology is likely immune-mediated. Virions are secreted into the bile and released in stool. HAV is excreted in large quantities ~11 days prior to appearance of symptoms or anti-HAV IgM antibodies in the blood (Wiki: Hepatitis A). Hepatitis A Following infection, the immune system makes antibodies against the hepatitis A virus that confer immunity against future infection (Wiki: Hepatitis A). Hepatitis virus (HAV) is a Picornavirus. It is non-enveloped and contains a single-stranded RNA packaged in a protein shell. There is only one type of the virus. HAV causes Hepatitis A (formerly known as infectious hepatitis), an acute infectious disease of the liver. This disease is most commonly transmitted by the fecal-oral route via contaminated food or drinking water. HAV infects approximately 10 million people every year worldwide, esp. in developing countries. The incubation period is 15-50 days, and mortality is less than 0.5%. Hepatitis A infection causes no clinical signs and symptoms in over 90% of infected children. Hepatitis A does not have a chronic stage and does not cause permanent liver damage. Following infection, the immune system makes antibodies against the hepatitis A virus that confer immunity against future infection (Wiki: Hepatitis A). Baboon Papio cynocephalus 9556 Bank vole Clethrionomys glareolus 447135 Bear Ursus americanus 9643 Birds Passeroidea 175121 Brown Trout Salmo trutta 8032 Buffalo Bison bison 9901 Carnivores Vulpes 9625 Cat Felis catus 9685 Catfishes Siluriformes 7995 Cattle Bos taurus 9913 Chicken Gallus gallus 9031 Chimpanzee Pan troglodytes 9598 chinchillas Chinchillidae 10150 Copper Pheasant Syrmaticus soemmerringii 9067 Deer Cervus elaphus 9860 Deer mouse Peromyscus maniculatus 10042 Dog Canis familiaris 9615 Ducks Anas 8835 Ferret Mustela putorius furo 9669 Fish Hyperotreti 117565 Gerbil Gerbillina 10045 Goat Capra hircus 9925 Gray wolf Canis lupus 9612 Guinea pig Cavia porcellus 10141 Hamster Mesocricetus auratus 10036 Horse Equus caballus 9796 Human Homo sapiens 9606 Macaque Macaca fascicularis 9541 Mongolian Gerbil Meriones unguiculatus 10047 Monkey Platyrrhini 9479 Mouse Mus musculus 10090 None None Parrot Psittacidae 9224 Pig Sus scrofa 9823 Rabbit Oryctolagus cuniculus 9986 Rainbow trout Oncorhynchus mykiss 8022 Rat Rattus 10114 Raven Corvus corax 56781 sei whale Balaenoptera borealis 9768 Sheep Ovis aries 9940 Squirrel Spermophilus richardsonii 37591 Tree shrew Tupaiidae 9393 Trouts, salmons & chars Salmoninae 504568 Turkey Meleagris gallopavo 9103 Vole Microtus ochrogaster 79684 Water buffalo Bubalus bubalis 391902 Avaxim Hepatitis A vaccine (inactivated, adsorbed) Avaxim Sanofi Pasteur Ltd VO_0010706 Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Killed virus. Other components: Formaldehyde. Aluminum hydroxide The vaccine must be stored in a refrigerator between 2°C and 8°C (EMC: Avaxim). Intramuscular injection (i.m.) Avaxim - Pediatric Hepatitis A Vaccine Inactivated Avaxim - Pediatric Sanofi Pasteur Ltd VO_0010707 Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Killed virus. Other components: Formaldehyde. Aluminum hydroxide Store at 2˚ to 8˚C (35˚ to 46˚ F). Do not freeze (SP: Avaxim Pediatrix). Intramuscular injection (i.m.) Epaxal Hepatitis A vaccine (inactivated, virosome) Epaxal Berna Biotech VO_0010713 Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Killed virus. Other components: Formaldehyde. Virosomes Store at 2-8°C (36-46°F) (EMC: Epaxal) Intramuscular injection (i.m.) Havrix Hepatitis A Vaccine, Inactivated Havrix GlaxoSmithKline Biologicals VO_0000052 Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) USA (License #1617), Canada Indication: To support lowering the age indication for Havrix from two years to 12 months of age (FDA: Havrix). Store refrigerated between 2° and 8°C (36° and 46°F) (FDA: Havrix). 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 detected by ELISA and expressed in terms of ELISA Units (EL.U.) (FDA: Havrix). Intramuscular injection (i.m.) Hepatitis A Vaccine, Inactivated In response to vaccination, 32 cases of clinical hepatitis A occurred in the control group. In the HAVRIX group, 2 cases were identified. These 2 cases were mild in terms of both biochemical and clinical indices of hepatitis A disease. A double-blind, randomized controlled study was conducted in school children (age 1 to 16 years) in Thailand who were at high risk of Hepatitis A Virus (HAV) infection. A total of 40,119 children were vaccinated with either HAVRIX or ENGERIX-B at 0, 1, and 12 months. 19,037 children received a primary course (doses at 0 and 1 months) of HAVRIX and 19,120 children received a primary course (doses at 0 and 1 months) of ENGERIX-B (FDA: Havrix). In response to vaccination, 32 cases of clinical hepatitis A occurred in the control group. In the HAVRIX group, 2 cases were identified. These 2 cases were mild in terms of both biochemical and clinical indices of hepatitis A disease. Therefore, the efficacy rate for prevention of clinical hepatitis A was 94% (FDA: Havrix). Side Effects of HAVRIX included: injection site pain, redness and swelling, irratibility, loss of appetite, and drowsiness. A multicenter study administered 720 EL.U./0.5mL of HAVRIX into infants 11 months and older. The same sample size and concentration was also administered in another study of infants 2 years of age and older (FDA: Havrix). In the 11 months and older study, each infant was administered either HAVRIX or were coadministered HAVRIX and INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and Haemophilus influenzae type b (Hib) conjugate vaccine (tetanus toxoid conjugate). The most common side effects recorded with this dosage concentration and amount were: injection site pain, redness, swelling, irritability, drowsiness, and loss of appetite After subjects were seropositive before each addtional booster was administered. A clinical study of children 2 years and older administered HAVRIX at 360 EL.U, and were given the follow-up booster shots at 1 and 6 months after the initial shot (FDA: Havrix). Side effects recorded included: pain, and redness of the injection site, swelling, irritability, drowsiness and loss of appetite. Hepatitis A Virus Vaccine AGM-27 Live, attenuated vaccine Research Intravenous injection (i.v.) A Simian Strain of Hepatitis A Virus, AGM-27, Functions as an Attenuated Vaccine for Chimpanzees (Emerson et al., 1996) The stock preparation of the AGM-27 strain of HAV consisted of a 10% (wt/vol) African green monkey liver homogenate in PBS. (Emerson et al., 1996) Intravenous injection (i.v.) AGM-27 strain of Hepatitis A Virus (Emerson et al., 1996) licensed Hepatitis A human vaccine Generic Unknown VO_0000646 Inactivated or "killed" vaccine Licensed A generic representation of vaccines utilized to prevent Hepatitis A infection in humans, most commonly formulated as inactivated (killed) whole-virus vaccines. These vaccines contain virus particles that have been rendered non-infectious, providing immunity without causing disease. Twinrix Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine Twinrix GlaxoSmithKline Biologicals VO_0000113 Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) USA (License #1617), Canada TWINRIX should be refrigerated between 2° and 8° C (36° and 46° F). Do not freeze. TWINRIX is a sterile suspension of inactivated hepatitis A virus (strain HM175) propagated in MRC-5 cells, and combined with purified surface antigen of the hepatitis B virus (FDA: TWINRIX). Intramuscular injection (i.m.) In clinical trials, it has been found that combining the hepatitis A antigen with the hepatitis B surface antigen in TWINRIX resulted in comparable anti-HAV or anti-HBsAg titers, relative to vaccination with the individual monovalent vaccines or the concomitant administration of each vaccine in opposite arms (FDA: TWINRIX). Side effects of immunization included: redness, itching and swelling of the injection site, headache and fatigue. Severe adverse effects were limited and resolved in a timely matter. Twinrix Junior Combined hepatitis A and hepatitis B vaccine Twinrix Junior GlaxoSmithKline VO_0010743 Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Recombinant protein + killed virus. Other components: Yeast protein Formaldehyde, Polysorbate 20. between 2° and 8° C (36° and 46° F). Do not freeze. Intramuscular injection (i.m.) VAQTA Hepatitis A Vaccine, Inactivated VAQTA Merck & Co, Inc VO_0010745 Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) USA (License #0002) Indication: Lowering the age indication for VAQTA from two years to 12 months of age (FDA: VAQTA). VAQTA is indicated for active immunization against disease caused by hepatitis A virus in persons 12 months of age and older. Primary immunization should be given at least 2 weeks prior to expected exposure to Hepatitis A Virus (HAV). Store vaccine at 2-8°C (36-46°F). VAQTA [Hepatitis A Vaccine, Inactivated] is an inactivated whole virus vaccine derived from hepatitis A virus (HAV) grown in cell culture in human MRC-5 diploid fibroblasts. It contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, purified by a combination of physical and high performance liquid chromatographic techniques developed at the Merck Research Laboratories, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulfate. One milliliter of the vaccine contains approximately 50 units (U) of hepatitis A virus antigen, which is purified and formulated without a preservative (FDA: VAQTA). Intramuscular injection (i.m.) Hepatitis A Vaccine, Inactivated No cases of Hepatitis A have been confirmed in response to vaccination with VAQTA. The protective efficacy, immunogenicity and safety of VAQTA were evaluated in a randomized, double-blind, placebo-controlled study involving 1037 healthy children and adolescents ages 2 through 16 years in a U.S. community with recurrent outbreaks of hepatitis A. Subjects were administered with either VAQTA or placebo (FDA: VAQTA) Injection Site Reactions included: pain, redness and swelling. Systemic Reactions included: rash and fever. The total duration of protective effect of VAQTA is unknown. When VAQTA was given as a booster dose following HAVRIX, the vaccine produced an adequate immune response, seropositivity and booster response were both high in all subjects. A clinical study was performed in 537 healthy adults, 18 to 83 years of age. The subjects were administered with a booster dose of VAQTA and HAVRIX†† (hepatitis A vaccine, inactivated) given at 6 or 12 months following an initial dose of HAVRIX (FDA: VAQTA). ViVaxim Combined Purified Vi Polysaccharide Typhoid and Inactivated Hepatitis A Vaccine ViVaxim Sanofi Pasteur Ltd VO_0010748 Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Polysaccharide + killed virus. Other components: Formaldehyde, Polysorbate 80. Aluminum hydroxide Store at 2° to 8°C (35° to 46°F). Intramuscular injection (i.m.) EMC: Avaxim website http://emc.medicines.org.uk/medicine/17385/PIL/AVAXIM/ EMC: Epaxal website http://emc.medicines.org.uk/medicine/12742/SPC/Epaxal/ FDA: Havrix website http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm110016.htm FDA: TWINRIX website http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094035.htm FDA: VAQTA website http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm110017.htm GSK: Twinrix website http://www.gsk.ca/english/docs-pdf/Twinrix_PM_20080916_EN.pdf Karayiannis et al., 1991 journal Karayiannis P, O'Rourke S, McGarvey MJ, Luther S, Waters J, Goldin R, Thomas HC 1991 72 ( Pt 9) 2167-2172 The Journal of general virology SP: Avaxim Pediatrix website https://www.vaccineshoppecanada.com/secure/pdfs/ca/Avaxim_Ped_E.pdf Wiki: Hepatitis A website http://en.wikipedia.org/wiki/Hepatitis_A_virus