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Hepatitis A virus

Table of Contents
  1. General Information
    1. NCBI Taxonomy ID
    2. Disease
    3. Introduction
    4. Microbial Pathogenesis
    5. Host Protective Immunity
  2. Vaccine Related Pathogen Genes
    1. HAVgp2 (Protective antigen)
  3. Vaccine Information
    1. Avaxim
    2. Avaxim - Pediatric
    3. Epaxal
    4. Havrix
    5. Hepatitis A Virus Vaccine AGM-27
    6. Twinrix
    7. Twinrix Junior
    8. VAQTA
    9. ViVaxim
  4. References
I. General Information
1. NCBI Taxonomy ID:
12092
2. Disease:
Hepatitis A
3. Introduction
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).
4. Microbial Pathogenesis
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).
5. Host Protective Immunity
Following infection, the immune system makes antibodies against the hepatitis A virus that confer immunity against future infection (Wiki: Hepatitis A).
1. HAVgp2
  • Gene Name : HAVgp2
  • Sequence Strain (Species/Organism) : Hepatovirus A
  • VO ID : VO_0010906
  • NCBI Gene ID : 1493919
  • NCBI Protein GI : 9626734
  • Locus Tag : HAVgp2
  • Genbank Accession : M14707
  • Protein Accession : NP_041008
  • Taxonomy ID : 12092
  • Gene Starting Position : 740
  • Gene Ending Position : 7417
  • Gene Strand (Orientation) : +
  • Protein Name : hypothetical protein
  • Protein pI : 6.48
  • Protein Weight : 235187.3
  • Protein Length : 2225
  • DNA Sequence : Show Sequence 
    >NC_001489.1:740-7417 Hepatitis A virus, complete genome
CATGTCTAGACAAGGTATTTTCCAGACTGTTGGGAGTGGTCTTGACCACATCCTGTCTTTGGCAGACATT
GAGGAAGAGCAAATGATTCAATCAGTTGATAGGACTGCAGTGACTGGTGCTTCTTATTTTACTTCTGTGG
ATCAATCTTCAGTTCATACAGCTGAGGTTGGATCACACCAGGTTGAACCTTTGAGAACCTCTGTTGATAA
ACCCGGTTCAAAGAAGACTCAGGGAGAGAAATTTTTCTTGATTCATTCTGCAGATTGGCTTACTACACAT
GCTCTTTTCCATGAAGTTGCAAAATTGGATGTGGTGAAATTATTATACAATGAGCAGTTTGCTGTTCAAG
GGTTGTTGAGATACCATACATATGCAAGATTTGGCATTGAAATTCAAGTTCAGATAAACCCTACACCTTT
CCAACAGGGGGGATTGATCTGTGCTATGGTTCCTGGTGACCAGAGCTATGGTTCTATAGCATCATTGACT
GTTTATCCTCATGGTTTGTTAAATTGCAATATTAACAATGTGGTTAGAATAAAGGTTCCATTTATTTACA
CAAGAGGTGCTTACCACTTTAAAGATCCACAATACCCAGTTTGGGAATTGACAATTAGAGTTTGGTCAGA
ATTAAATATTGGGACAGGAACTTCAGCTTATACTTCACTCAATGTTTTAGCTAGATTTACAGATTTGGAG
TTGCATGGATTAACTCCTCTTTCTACACAAATGATGAGAAATGAATTTAGGGTCAGTACTACTGAGAATG
TGGTGAATCTGTCAAATTATGAAGATGCAAGAGCAAAGATGTCTTTTGCTTTGGATCAGGAAGATTGGAA
ATCTGATCCGTCCCAGGGTGGTGGGATCAAAATTACTCATTTTACTACTTGGACATCTATTCCAACTTTG
GCTGCTCAGTTTCCATTTAATGCTTCAGACTCAGTTGGTCAACAAATTAAAGTTATTCCAGTTGACCCAT
ATTTTTTCCAAATGACAAATACGAATCCTGACCAAAAATGTATAACTGCTTTGGCTTCTATTTGTCAGAT
GTTTTGTTTTTGGAGAGGAGATCTTGTCTTTGATTTTCAAGTTTTTCCCACCAAATATCATTCAGGTAGA
TTACTGTTTTGTTTTGTTCCTGGCAATGAGCTAATAGATGTTTCTGGAATCACATTAAAGCAAGCAACTA
CTGCTCCTTGTGCAGTAATGGATATTACAGGAGTGCAGTCAACTTTGAGATTTCGTGTTCCCTGGATTTC
TGACACTCCTTACAGAGTGAACAGGTATACAAAGTCAGCACATCAGAAAGGTGAGTACACTGCCATTGGG
AAGCTTATTGTGTATTGTTATAACAGATTGACCTCTCCTTCTAACGTTGCTTCCCATGTCAGAGTGAATG
TTTATCTTTCAGCAATTAACTTGGAATGTTTTGCTCCTCTTTATCATGCTATGGATGTTACTACACAAGT
TGGAGATGATTCTGGAGGTTTTTCAACAACAGTTTCTACAGAACAGAATGTTCCAGATCCCCAAGTTGGT
ATAACAACCATGAAAGATTTGAAAGGAAAAGCTAACAGAGGGAAAATGGATGTTTCAGGAGTACAAGCAC
CTGTGGGAGCTATCACAACAATTGAGGATCCAGTTTTAGCAAAGAAAGTACCTGAGACATTTCCTGAATT
GAAACCTGGAGAATCCAGACATACATCAGATCATATGTCCATCTACAAGTTTATGGGAAGGTCTCATTTC
TTGTGCACTTTTACATTCAATTCAAATAATAAAGAGTACACATTTCCTATAACCTTGTCTTCAACCTCTA
ATCCTCCTCATGGTTTGCCATCAACACTGAGGTGGTTTTTCAACTTGTTTCAGTTGTATAGAGGGCCTTT
AGATCTGACAATTATTATTACAGGAGCAACTGATGTAGATGGCATGGCCTGGTTCACTCCAGTAGGTCTT
GCCGTTGATACTCCTTGGGTAGAGAAGGAGTCAGCTTTGTCTATTGACTACAAAACTGCTCTTGGAGCTG
TCAGATTTAACACAAGGAGAACAGGGAACATTCAGATTAGATTACCATGGTATTCTTATTTATATGCTGT
GTCTGGAGCACTGGATGGTTTGGGTGACAAGACAGATTCTACATTTGGATTGGTTTCTATTCAGATTGCA
AATTACAATCATTCTGATGAATACTTGTCTTTTAGTTGTTATTTGTCTGTCACAGAACAATCAGAGTTTT
ATTTTCCCAGAGCTCCATTGAACTCAAATGCCATGTTATCCACTGAATCAATGATGAGCAGAATTGCAGC
TGGAGACTTGGAGTCATCAGTGGATGATCCTAGATCAGAGGAAGATAAAAGATTTGAGAGTCATATAGAA
TGCAGGAAGCCATATAAAGAACTGAGATTAGAAGTTGGGAAACAAAGACTCAAGTATGCTCAGGAAGAAT
TGTCAAATGAAGTACTTCCACCCCCTAGGAAAATGAAGGGACTGTTTTCACAAGCCAAAATTTCTCTTTT
TTATACTGAGGAGCATGAAATAATGAAGTTTTCCTGGAGAGGTGTGACTGCTGATACTAGAGCTTTAAGG
AGGTTTGGATTCTCTTTGGCCGCAGGCAGAAGTGTGTGGACTCTTGAAATGGATGCTGGGGTTCTTACTG
GGAGACTGATTAGATTGAATGATGAGAAATGGACAGAAATGAAGGATGACAAGATTGTTTCATTGATTGA
AAAGTTTACAAGTAACAAATATTGGTCCAAAGTGAATTTCCCACATGGGATGTTGGATCTTGAAGAAATT
GCTGCCAATTCTAAGGATTTTCCTAACATGTCTGAAACGGATTTGTGTTTCTTGCTGCATTGGTTAAATC
CAAAGAAAATTAATTTAGCAGATAGAATGCTTGGATTGTCTGGAGTTCAGGAAATTAAAGAACAAGGTGT
TGGATTAATAGCAGAGTGTAGAACTTTCTTAGATTCTATTGCTGGAACTTTAAAATCTATGATGTTTGGA
TTTCATCATTCTGTGACTGTTGAAATTATAAACACTGTGCTCTGTTTTGTTAAGAGTGGAATTTTGCTTT
ATGTAATACAACAATTGAATCAGGATGAACATTCTCACATAATTGGTTTGTTGAGAGTCATGAATTATGC
AGATATTGGTTGTTCAGTTATTTCATGTGGCAAAGTTTTTTCCAAAATGCTGGAAACAGTCTTTAATTGG
CAAATGGACTCCAGAATGATGGAGTTAAGGACTCAGAGTTTTTCCAACTGGTTAAGAGATATTTGTTCTG
GGATCACCATTTTTAAAAACTTCAAGGATGCAATTTATTGGCTTTATACAAAATTAAAGGACTTTTATGA
AGTGAATTATGGCAAGAAGAAGGACATTTTAAATATTCTTAAAGATAACCAACAAAAAATAGAGAAAGCC
ATTGAGGAAGCCGATGAATTTTGCATTTTGCAAATCCAAGATGTGGAAAAATTTGAACAGTATCAGAAAG
GGGTTGACTTGATACAAAAATTGAGAACTGTTCATTCAATGGCTCAGGTTGATCCAAATTTAATGGTTCA
TTTGTCACCTTTGAGAGATTGTATAGCAAGAGTTCATCAGAAACTTAAAAACCTTGGATCTATAAATCAG
GCAATGGTAACGAGATGTGAGCCAGTTGTTTGTTATTTATATGGCAAAAGAGGGGGAGGAAAGAGCTTAA
CATCAATTGCATTGGCAACCAAAATTTGTAAACATTATGGTGTTGAGCCTGAAAAGAATATCTATACTAA
ACCTGTGGCTTCAGATTACTGGGATGGATATAGTGGACAATTAGTTTGCATCATTGATGATATTGGCCAA
AACACAACAGATGAGGATTGGTCAGATTTTTGTCAGTTAGTGTCAGGATGTCCAATGAGATTAAACATGG
CCTCTCTTGAGGAGAAGGGTAGGCATTTTTCTTCTCCTTTTATAATAGCAACTTCAAATTGGTCAAATCC
AAGTCCAAAAACAGTTTATGTTAAGGAAGCAATTGACCGCAGACTCCATTTCAAGGTTGAAGTTAAACCT
GCTTCATTTTTCAAAAATCCTCACAATGATATGTTGAATGTTAATTTAGCTAAAACAAATGATGCAATCA
AAGATATGTCTTGTGTTGATTTGATAATGGATGGACATAATGTTTCATTGATGGATTTGCTCAGTTCTTT
AGTCATGACAGTTGAAATTAGAAAACAAAACATGACTGAATTCATGGAGTTGTGGTCTCAGGGAATTTCA
GATGATGATAATGATAGTGCAGTAGCTGAGTTTTTCCAGTCTTTTCCATCTGGTGAACCATCGAACTCTA
AATTATCTGGCTTTTTCCAATCTGTTACTAATCACAAGTGGGTTGCTGTGGGAGCTGCAGTTGGCATTCT
TGGAGTGCTCGTTGGAGGATGGTTTGTGTATAAGCATTTCTCCCGCAAAGAGGAGGAACCAATCCCAGCT
GAAGGGGTATATCATGGTGTAACTAAGCCCAAGCAAGTGATTAAATTAGATGCAGATCCAGTAGAATCTC
AGTCAACTTTGGAAATAGCAGGACTGGTTAGGAAGAACTTGGTTCAGTTTGGAGTTGGAGAGAAGAATGG
ATGTGTGAGATGGGTTATGAATGCCTTGGGAGTGAAAGATGATTGGCTGCTTGTGCCTTCCCATGCTTAT
AAATTTGAGAAAGATTATGAAATGATGGAGTTTTATTTTAATAGAGGTGGAACTTACTATTCAATTTCAG
CTGGTAATGTTGTTATTCAATCTTTGGATGTGGGATTCCAGGATGTTGTTCTGATGAAGGTTCCTACAAT
TCCTAAGTTTAGAGATATTACTCAGCATTTTATTAAGAAAGGGGATGTGCCTAGAGCTTTGAATCGCCTG
GCAACATTAGTGACAACTGTAAATGGAACCCCTATGTTAATTTCTGAGGGCCCACTAAAGATGGAAGAGA
AAGCTACTTATGTTCATAAGAAAAATGATGGTACAACAGTTGATTTAACTGTGGATCAGGCATGGAGAGG
AAAAGGCGAAGGTCTTCCTGGAATGTGTGGTGGGGCCTTGGTTTCATCGAATCAATCTATACAGAATGCA
ATCTTGGGCATCCATGTTGCTGGAGGAAATTCAATTCTTGTTGCAAAATTGGTTACTCAAGAAATGTTCC
AAAATATTGATAAGAAAATTGAAAGTCAGAGAATTATGAAAGTGGAGTTTACTCAGTGTTCAATGAATGT
GGTCTCCAAAACGCTTTTTAGAAAGAGTCCCATTTATCATCACATTGATAAAACCATGATTAATTTTCCT
GCAGCTATGCCCTTTTCTAAAGCTGAAATTGATCCAATGGCTGTGATGTTATCTAAGTATTCATTACCTA
TTGTAGAAGAACCAGAGGATTATAAAGAGGCTTCAATTTTTTATCAAAATAAAATAGTGGGTAAGACTCA
GTTAGTTGATGATTTTTTAGATCTTGATATGGCCATTACAGGGGCCCCAGGAATTGATGCTATCAACATG
GATTCATCTCCTGGATTTCCTTATGTCCAGGAGAAGTTGACCAAAAGAGATTTAATTTGGTTGGATGAAA
ATGGTTTATTGCTGGGAGTTCATCCAAGATTGGCTCAGAGAATCTTATTCAATACTGTCATGATGGAAAA
TTGTTCTGATTTGGATGTTGTTTTTACAACCTGTCCAAAAGATGAATTGAGACCATTAGAGAAAGTGTTG
GAATCAAAAACAAGAGCTATTGATGCTTGTCCTCTGGATTACTCAATTTTGTGCCGAATGTATTGGGGTC
CAGCTATTAGTTATTTTCATTTGAATCCAGGTTTCCATACAGGTGTTGCTATTGGCATAGATCCTGATAG
ACAGTGGGATGAATTATTTAAAACAATGATAAGATTCGGAGATGTTGGTCTTGATTTAGATTTCTCTGCT
TTTGATGCTAGTCTTAGTCCATTTATGATTAGAGAAGCAGGTAGAATCATGAGTGAACTATCTGGAACTC
CATCCCATTTTGGCACAGCTCTTATCAATACTATCATTTATTCCAAGCATTTGCTGTATAACTGTTGTTA
CCATGTCTGTGGTTCAATGCCCTCTGGGTCTCCTTGTACAGCTTTGCTAAATTCAATTATTAATAATGTC
AATTTGTATTATGTGTTTTCCAAGATATTTGGAAAGTCTCCAGTTTTCTTTTGTCAGGCTTTGAAGATTC
TCTGTTATGGAGATGATGTTTTAATAGTTTTCTCTCGAGATGTTCAGATTGATAATCTTGATTTGATTGG
ACAAAAAATTGTAGATGAGTTTAAGAAACTTGGCATGACAGCTACTTCTGCTGACAAGAATGTACCTCAG
CTGAAACCAGTTTCGGAATTGACTTTTCTCAAAAGATCTTTCAATTTGGTAGAGGATAGAATTAGACCTG
CAATTTCGGAAAAAACAATTTGGTCTTTAATAGCATGGCAGAGAAGTAACGCTGAGTTTGAGCAGAATTT
AGAAAATGCTCAGTGGTTTGCTTTTATGCATGGCTATGAGTTTTATCAGAAATTTTATTATTTTGTTCAG
TCCTGTTTGGAGAAAGAGATGATAGAATACAGACTTAAATCTTATGATTGGTGGAGAATGAGATTTTATG
ACCAGTGTTTCATTTGTGACCTTTCATG
  • Protein Sequence : Show Sequence 
    >NP_041008.1 hypothetical protein HAVgp2 [Hepatovirus A]
MSRQGIFQTVGSGLDHILSLADIEEEQMIQSVDRTAVTGASYFTSVDQSSVHTAEVGSHQVEPLRTSVDK
PGSKKTQGEKFFLIHSADWLTTHALFHEVAKLDVVKLLYNEQFAVQGLLRYHTYARFGIEIQVQINPTPF
QQGGLICAMVPGDQSYGSIASLTVYPHGLLNCNINNVVRIKVPFIYTRGAYHFKDPQYPVWELTIRVWSE
LNIGTGTSAYTSLNVLARFTDLELHGLTPLSTQMMRNEFRVSTTENVVNLSNYEDARAKMSFALDQEDWK
SDPSQGGGIKITHFTTWTSIPTLAAQFPFNASDSVGQQIKVIPVDPYFFQMTNTNPDQKCITALASICQM
FCFWRGDLVFDFQVFPTKYHSGRLLFCFVPGNELIDVSGITLKQATTAPCAVMDITGVQSTLRFRVPWIS
DTPYRVNRYTKSAHQKGEYTAIGKLIVYCYNRLTSPSNVASHVRVNVYLSAINLECFAPLYHAMDVTTQV
GDDSGGFSTTVSTEQNVPDPQVGITTMKDLKGKANRGKMDVSGVQAPVGAITTIEDPVLAKKVPETFPEL
KPGESRHTSDHMSIYKFMGRSHFLCTFTFNSNNKEYTFPITLSSTSNPPHGLPSTLRWFFNLFQLYRGPL
DLTIIITGATDVDGMAWFTPVGLAVDTPWVEKESALSIDYKTALGAVRFNTRRTGNIQIRLPWYSYLYAV
SGALDGLGDKTDSTFGLVSIQIANYNHSDEYLSFSCYLSVTEQSEFYFPRAPLNSNAMLSTESMMSRIAA
GDLESSVDDPRSEEDKRFESHIECRKPYKELRLEVGKQRLKYAQEELSNEVLPPPRKMKGLFSQAKISLF
YTEEHEIMKFSWRGVTADTRALRRFGFSLAAGRSVWTLEMDAGVLTGRLIRLNDEKWTEMKDDKIVSLIE
KFTSNKYWSKVNFPHGMLDLEEIAANSKDFPNMSETDLCFLLHWLNPKKINLADRMLGLSGVQEIKEQGV
GLIAECRTFLDSIAGTLKSMMFGFHHSVTVEIINTVLCFVKSGILLYVIQQLNQDEHSHIIGLLRVMNYA
DIGCSVISCGKVFSKMLETVFNWQMDSRMMELRTQSFSNWLRDICSGITIFKNFKDAIYWLYTKLKDFYE
VNYGKKKDILNILKDNQQKIEKAIEEADEFCILQIQDVEKFEQYQKGVDLIQKLRTVHSMAQVDPNLMVH
LSPLRDCIARVHQKLKNLGSINQAMVTRCEPVVCYLYGKRGGGKSLTSIALATKICKHYGVEPEKNIYTK
PVASDYWDGYSGQLVCIIDDIGQNTTDEDWSDFCQLVSGCPMRLNMASLEEKGRHFSSPFIIATSNWSNP
SPKTVYVKEAIDRRLHFKVEVKPASFFKNPHNDMLNVNLAKTNDAIKDMSCVDLIMDGHNVSLMDLLSSL
VMTVEIRKQNMTEFMELWSQGISDDDNDSAVAEFFQSFPSGEPSNSKLSGFFQSVTNHKWVAVGAAVGIL
GVLVGGWFVYKHFSRKEEEPIPAEGVYHGVTKPKQVIKLDADPVESQSTLEIAGLVRKNLVQFGVGEKNG
CVRWVMNALGVKDDWLLVPSHAYKFEKDYEMMEFYFNRGGTYYSISAGNVVIQSLDVGFQDVVLMKVPTI
PKFRDITQHFIKKGDVPRALNRLATLVTTVNGTPMLISEGPLKMEEKATYVHKKNDGTTVDLTVDQAWRG
KGEGLPGMCGGALVSSNQSIQNAILGIHVAGGNSILVAKLVTQEMFQNIDKKIESQRIMKVEFTQCSMNV
VSKTLFRKSPIYHHIDKTMINFPAAMPFSKAEIDPMAVMLSKYSLPIVEEPEDYKEASIFYQNKIVGKTQ
LVDDFLDLDMAITGAPGIDAINMDSSPGFPYVQEKLTKRDLIWLDENGLLLGVHPRLAQRILFNTVMMEN
CSDLDVVFTTCPKDELRPLEKVLESKTRAIDACPLDYSILCRMYWGPAISYFHLNPGFHTGVAIGIDPDR
QWDELFKTMIRFGDVGLDLDFSAFDASLSPFMIREAGRIMSELSGTPSHFGTALINTIIYSKHLLYNCCY
HVCGSMPSGSPCTALLNSIINNVNLYYVFSKIFGKSPVFFCQALKILCYGDDVLIVFSRDVQIDNLDLIG
QKIVDEFKKLGMTATSADKNVPQLKPVSELTFLKRSFNLVEDRIRPAISEKTIWSLIAWQRSNAEFEQNL
ENAQWFAFMHGYEFYQKFYYFVQSCLEKEMIEYRLKSYDWWRMRFYDQCFICDLS
  • Molecule Role : Protective antigen
  • Molecule Role Annotation : A recombinant vaccinia virus containing most of the P1 region of hepatitis A virus (HAV) was constructed bearing epitopes from structural polypeptides VP4, -3 and -2, and the N terminus of VP. Inoculation of tamarin monkeys with the recombinant virus resulted in the development of a specific anti-HAV immune response which was protective against challenge with a virulent strain of HAV (Karayiannis et al., 1991).
III. Vaccine Information
1. Avaxim
a. Product Name:
Hepatitis A vaccine (inactivated, adsorbed)
b. Tradename:
Avaxim
c. Manufacturer:
Sanofi Pasteur Ltd
d. Vaccine Ontology ID:
VO_0010706
e. Type:
Inactivated or "killed" vaccine
f. Status:
Licensed
g. Location Licensed:
Canada
h. Host Species for Licensed Use:
Human
i. Adjuvant:
j. Preservative:
2 phenoxy ethanol
k. Allergen:
Neomycin
l. Immunization Route
Intramuscular injection (i.m.)
m. Storage
The vaccine must be stored in a refrigerator between 2°C and 8°C (EMC: Avaxim).
n . Approved Age for Licensed Use
16 years and older (EMC: Avaxim)
o. Description
Products: Killed virus. Other components: Formaldehyde.
2. Avaxim - Pediatric
a. Product Name:
Hepatitis A Vaccine Inactivated
b. Tradename:
Avaxim - Pediatric
c. Manufacturer:
Sanofi Pasteur Ltd
d. Vaccine Ontology ID:
VO_0010707
e. Type:
Inactivated or "killed" vaccine
f. Status:
Licensed
g. Location Licensed:
Canada
h. Host Species for Licensed Use:
Human
i. Adjuvant:
j. Preservative:
2 phenoxy ethanol
k. Allergen:
Neomycin
l. Immunization Route
Intramuscular injection (i.m.)
m. Storage
Store at 2˚ to 8˚C (35˚ to 46˚ F). Do not freeze (SP: Avaxim Pediatrix).
n . Approved Age for Licensed Use
1 to 15 years of age (SP: Avaxim Pediatrix)
o. Description
Products: Killed virus. Other components: Formaldehyde.
3. Epaxal
a. Product Name:
Hepatitis A vaccine (inactivated, virosome)
b. Tradename:
Epaxal
c. Manufacturer:
Berna Biotech
d. Vaccine Ontology ID:
VO_0010713
e. Type:
Inactivated or "killed" vaccine
f. Status:
Licensed
g. Location Licensed:
Canada
h. Host Species for Licensed Use:
Human
i. Preservative:
Thimerosal
j. Immunization Route
Intramuscular injection (i.m.)
k. Storage
Store at 2-8°C (36-46°F) (EMC: Epaxal)
l . Approved Age for Licensed Use
1 year and older (EMC: Epaxal)
m. Description
Products: Killed virus. Other components: Formaldehyde.
4. Havrix
a. Product Name:
Hepatitis A Vaccine, Inactivated
b. Tradename:
Havrix
c. Manufacturer:
GlaxoSmithKline Biologicals
d. Vaccine Ontology ID:
VO_0000052
e. CDC CVX code:
52, 83
f. Type:
Inactivated or "killed" vaccine
g. Status:
Licensed
h. Location Licensed:
USA (License #1617), Canada
i. Host Species for Licensed Use:
Human
j. Antigen
Hepatitis A Vaccine, Inactivated
k. Adjuvant:
  • VO ID: VO_0000884
  • Description: Aluminum hydroxide
l. Preservative:
2 phenoxy ethanol (PE)
m. Preparation
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).
n. Immunization Route
Intramuscular injection (i.m.)
o. Storage
Store refrigerated between 2° and 8°C (36° and 46°F) (FDA: Havrix).
p . Approved Age for Licensed Use
Ages greater than 12 months (FDA: Havrix).
q. Contraindication
HAVRIX can cause a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin. Hepatitis A vaccine may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination (FDA: Havrix).
r. Description
Indication: To support lowering the age indication for Havrix from two years to 12 months of age (FDA: Havrix).
s. Human Response
  • Vaccination Protocol: 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).
  • Immune Response: 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.
  • Side Effects: Side Effects of HAVRIX included: injection site pain, redness and swelling, irratibility, loss of appetite, and drowsiness.
  • Efficacy: 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).
t. Human Response
  • Vaccination Protocol: 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).
  • Side Effects: The most common side effects recorded with this dosage concentration and amount were: injection site pain, redness, swelling, irritability, drowsiness, and loss of appetite
u. Human Response
  • Vaccination Protocol: 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).
  • Immune Response: After subjects were seropositive before each addtional booster was administered.
  • Side Effects: Side effects recorded included: pain, and redness of the injection site, swelling, irritability, drowsiness and loss of appetite.
5. Hepatitis A Virus Vaccine AGM-27
a. Type:
Live, attenuated vaccine
b. Status:
Research
c. Host Species for Licensed Use:
None
d. Antigen
AGM-27 strain of Hepatitis A Virus (Emerson et al., 1996)
e. Preparation
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)
f. Immunization Route
Intravenous injection (i.v.)
g. Description
A Simian Strain of Hepatitis A Virus, AGM-27, Functions as an Attenuated Vaccine for Chimpanzees (Emerson et al., 1996)
6. Twinrix
a. Product Name:
Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine
b. Tradename:
Twinrix
c. Manufacturer:
GlaxoSmithKline Biologicals
d. Vaccine Ontology ID:
VO_0000113
e. CDC CVX code:
104
f. Type:
Inactivated or "killed" vaccine
g. Status:
Licensed
h. Location Licensed:
USA (License #1617), Canada
i. Host Species for Licensed Use:
Human
j. Allergen:
Neomycin, latex
k. Preparation
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).
l. Immunization Route
Intramuscular injection (i.m.)
m. Storage
TWINRIX should be refrigerated between 2° and 8° C (36° and 46° F). Do not freeze.
n . Approved Age for Licensed Use
Ages 18 and older (FDA: Havrix).
o. Contraindication
TWINRIX should not be administered to anyone with known hypersensitivity to any component of the vaccine, including yeast and neomycin and in patients with previous hypersensitivity to TWINRIX or monovalent hepatitis A or hepatitis B vaccines (FDA: Havrix).
p. Human Response
  • Immune Response: 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: 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.
7. Twinrix Junior
a. Product Name:
Combined hepatitis A and hepatitis B vaccine
b. Tradename:
Twinrix Junior
c. Manufacturer:
GlaxoSmithKline
d. Vaccine Ontology ID:
VO_0010743
e. Type:
Subunit vaccine + Inactivated or "killed" vaccine
f. Status:
Licensed
g. Location Licensed:
Canada
h. Host Species for Licensed Use:
Human
i. Preservative:
2 phenoxy ethanol
j. Allergen:
Neomycin, Latex in plunger stopper of pre-filled syringes
k. Immunization Route
Intramuscular injection (i.m.)
l. Storage
between 2° and 8° C (36° and 46° F). Do not freeze.
m . Approved Age for Licensed Use
Ages 1-18 (GSK: Twinrix)
n. Description
Products: Recombinant protein + killed virus. Other components: Yeast protein Formaldehyde, Polysorbate 20.
8. VAQTA
a. Product Name:
Hepatitis A Vaccine, Inactivated
b. Tradename:
VAQTA
c. Manufacturer:
Merck & Co, Inc
d. Vaccine Ontology ID:
VO_0000118
e. CDC CVX code:
52, 83
f. Type:
Inactivated or "killed" vaccine
g. Status:
Licensed
h. Location Licensed:
USA (License #0002)
i. Host Species for Licensed Use:
Human
j. Antigen
Hepatitis A Vaccine, Inactivated
k. Preparation
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).
l. Immunization Route
Intramuscular injection (i.m.)
m. Storage
Store vaccine at 2-8°C (36-46°F).
n . Approved Age for Licensed Use
Ages 12 months and older (FDA: VAQTA).
o. Contraindication
Hepatitis A vaccine should not be administered to persons with a history of a severe reaction to a prior dose of hepatitis A vaccine or to a vaccine component.
p. Description
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).
q. Human Response
  • Vaccination Protocol: 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)
  • Immune Response: No cases of Hepatitis A have been confirmed in response to vaccination with VAQTA.
  • Side Effects: Injection Site Reactions included: pain, redness and swelling. Systemic Reactions included: rash and fever.
  • Description: The total duration of protective effect of VAQTA is unknown.
r. Horse Response
  • Vaccination Protocol: 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).
  • Immune Response: 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.
9. ViVaxim
a. Product Name:
Combined Purified Vi Polysaccharide Typhoid and Inactivated Hepatitis A Vaccine
b. Tradename:
ViVaxim
c. Manufacturer:
Sanofi Pasteur Ltd
d. Vaccine Ontology ID:
VO_0010748
e. Type:
Subunit vaccine + Inactivated or "killed" vaccine
f. Status:
Licensed
g. Location Licensed:
Canada
h. Host Species for Licensed Use:
Human
i. Adjuvant:
  • VO ID: VO_0000127
  • Description: Products: Polysaccharide + killed virus. Other components: Formaldehyde, Polysorbate 80.
j. Preservative:
2 phenoxy ethanol
k. Allergen:
Neomycin
l. Immunization Route
Intramuscular injection (i.m.)
m. Storage
Store at 2° to 8°C (35° to 46°F).
n . Approved Age for Licensed Use
16 years of age and older.
o. Description
Products: Polysaccharide + killed virus. Other components: Formaldehyde, Polysorbate 80.
IV. References
1. EMC: Avaxim: The electronic Medicines Compendium: Avaxim [http://emc.medicines.org.uk/medicine/17385/PIL/AVAXIM/]
2. EMC: Epaxal: EMC: Epaxal Product Information [http://emc.medicines.org.uk/medicine/12742/SPC/Epaxal/]
3. FDA: Havrix: FDA: Havrix vaccine information [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm110016.htm]
4. FDA: TWINRIX: FDA: TWINRIX [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094035.htm]
5. FDA: VAQTA: FDA: VAQTA vaccine information [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm110017.htm]
6. GSK: Twinrix: GSK: Twinrix Product information [http://www.gsk.ca/english/docs-pdf/Twinrix_PM_20080916_EN.pdf]
7. Karayiannis et al., 1991: Karayiannis P, O'Rourke S, McGarvey MJ, Luther S, Waters J, Goldin R, Thomas HC. A recombinant vaccinia virus expressing hepatitis A virus structural polypeptides: characterization and demonstration of protective immunogenicity. The Journal of general virology. 1991; 72 ( Pt 9); 2167-2172. [PubMed: 1654376].
8. SP: Avaxim Pediatrix: SP: Avaxim Pediatrix [https://www.vaccineshoppecanada.com/secure/pdfs/ca/Avaxim_Ped_E.pdf]
9. Wiki: Hepatitis A: Wiki: Hepatitis A virus [http://en.wikipedia.org/wiki/Hepatitis_A_virus]