VIOLIN: Vaccine Investigation and Online Information Network

Hepatitis B virus

Table of Contents

General Information
Vaccine Related Pathogen Genes
1. Envelope proteins (Other)
2. HBcAg (Other)
3. HbS (Other)
4. Large HBsAg (Other)
5. ORF-2 (Other)
6. envelope (Protective antigen)
7. HBVgp2 pre-S1/pre-S2/S (Protective antigen)
8. PreS2+S (Middle protein) (Protective antigen)
9. S (Protective antigen)
10. S (Protective antigen)
11. S (Protective antigen)
12. S (Protective antigen)
13. S (Protective antigen)
14. HBVgp3 X protein (Virmugen)
Vaccine Information
References

I. General Information

1. NCBI Taxonomy ID:

10407

2. Disease:

Hepatitis B

3. Introduction

Hepatitis B virus is a DNA virus that infects the liver of hominoidae (including humans) and causes hepatitis. It has caused epidemics in parts of Asia and Africa. About a third of the world's population, more than 2 billion people, have been infected with the hepatitis B virus. The acute illness causes liver inflammation, vomiting, jaundice and - rarely - death. Chronic hepatitis B may eventually cause liver cirrhosis and liver cancer. This disease is preventable by vaccination (Wiki: Hepatitis B).

4. Microbial Pathogenesis

HBV primarily interferes with the functions of the liver by replicating in hepatocytes. HBV virions bind to the host cell via the preS domain of the viral surface antigen, leading to subsequent internalization through endocytosis. HBV-preS specific receptors are primarily expressed on hepatocytes. During HBV infection, the host immune response causes both hepatocellular damage and viral clearance. The innate immune response does not play a significant role in these processes. The adaptive immune response, particularly virus-specific cytotoxic T lymphocytes (CTLs), contributes to most of the liver injury associated with HBV infection. Liver damage is initiated and mediated by the CTLs. Antigen-nonspecific inflammatory cells can worsen CTL-induced immunopathology (Wiki: Hepatitis B).

5. Host Ranges and Animal Models

Hepatitis B virus infects the liver of apes including humans (Wiki: Hepatitis B).

6. Host Protective Immunity

During HBV infection, the host immune response causes both hepatocellular damage and viral clearance. Although the innate immune response does not play a significant role in these processes, the adaptive immune response, particularly virus-specific cytotoxic T lymphocytes (CTLs), contributes to most of the liver injury associated with HBV infection. By killing infected cells and by producing antiviral cytokines capable of purging HBV from viable hepatocytes, CTLs eliminate the virus. Although liver damage is initiated and mediated by the CTLs, antigen-nonspecific inflammatory cells can worsen CTL-induced immunopathology, and platelets activated at the site of infection may facilitate the accumulation of CTLs in the liver (Wiki: Hepatitis B).

II. Vaccine Related Pathogen Genes

1. envelope

Gene Name : envelope
Sequence Strain (Species/Organism) : Hepatitis B virus
VO ID : VO_0011094
NCBI Protein GI : 113207330
Other Database IDs : CDD:279085
GOA:Q0KG42
InterPro: IPR000349
UniProtKB/TrEMBL: Q0KG42
Taxonomy ID : 10407
Gene Strand (Orientation) : ?
Protein Name : preS2 middle surface protein
Protein pI : 8.04
Protein Weight : 30292.77
Protein Length : 348
Protein Note : sub-genotype: A3

Protein Sequence : Show Sequence

>CAJ75787.1 preS2 middle surface protein [Hepatitis B virus]
MQWNSTAFHQALQDPRVRGLYFPAGGSSSGTVSPVPNIASHISSISSRTGDPAPTMENITSGFLGPLLVL
QAGFFLLTRILTIPQSLDSWWTSLNFLGGSPVCLGQNSQSPTSNHSPTSCPPICPGYRWMCLRRFIIFLF
ILLLCLIFLLVLLDYQGMLPVCPLIPGSTTTSTGPCRTCTTPAQGNSMFPSCCCTKPTDGNCTCIPIPSS
WAFAKYLWEWASVRFSWLSLLVPFVQWFVGLSPTVWLSAIWMMWYWGPSLYNILSPFIPLLPIFFCLWVY
I

Molecule Role : Protective antigen
Molecule Role Annotation : The immunological protection of pVAX-PS, a DNA vaccine, was assessed in the tree shrews model. pVAX-PS was constructed by inserting the gene encoding the middle (pre-S2 plus S) envelope protein of HBV into a plasmid vector pVAX1. Results indicated that pVAX-PS immunization could induce remarkable humoral immune response and prevent the experimental tree shrews from infection of HBV (Zhou et al., 2003).
Related Vaccine(s): Hepatitis B virus DNA vaccine pVAX-PS

2. Envelope proteins

Gene Name : Envelope proteins
Sequence Strain (Species/Organism) : Hepatitis B virus
NCBI Protein GI : 1510158
Other Database IDs : CDD:109739
Taxonomy ID : 10407
Gene Strand (Orientation) : ?
Protein Name : envelope proteins
Protein Length : 281
Protein Note : Major surface antigen from hepadnavirus; pfam00695

Protein Sequence : Show Sequence

>gi|1510158|dbj|BAA00944.1| envelope proteins [Hepatitis B virus]
MQWNSTTFHQALLDPRVRGLYFPAGGSSSGTVNPVPTTASPISSIFSRTGDPAPNMESTTSGFLGPLLVL
QAGFFLLTRILTIPQSLDSWWTSLNFLGGAPTCPGQNSQSPTSNHSPTSCPPICPGYRWMCLRRFIIFLF
ILLLCLIFLLVLLDYQGMLPVCPLLPGTSTTSTGPCKTCTIPAQGTSMFPSCCCTKPSDRNCTCIPIPSS
WAFARFLWEWASVRFSWLNLLVPFVQWFAGLSPTVWLSVIWMMWYWGPSLYNILSPFLPLLPIFFCLWVY
I

Molecule Role : Other
Related Vaccine(s): Hepatitis B DNA vaccine pS encoding major envelope proteins

3. HBcAg

Gene Name : HBcAg
Sequence Strain (Species/Organism) : Hepatitis B virus
NCBI Protein GI : 560096
Other Database IDs : CDD:109943
Taxonomy ID : 10407
Gene Strand (Orientation) : ?
Protein Name : HBcAg
Protein Length : 183
Protein Note : Hepatitis core antigen; pfam00906

Protein Sequence : Show Sequence

>gi|560096|dbj|BAA04934.1| HBcAg [Hepatitis B virus]
MDIDPYKEFGASAELLSFLPSDFFPSIRDLLDTASALYREALESPEHCSPHHTALRQAILCWGELMNLAT
WVGSNLEDPASRELVVGYVNVNMGLKLRQLLWFHVSCLTFGRETVLEYLVSFGVWIRTPPAYRPPNAPIL
STLPETTVVRRRGRSPRRRTPSPRRRRSQSPRRRRSQSRESQC

Molecule Role : Other

4. HbS

Gene Name : HbS
Sequence Strain (Species/Organism) : Hepatitis B virus
NCBI Protein GI : 15384573
Other Database IDs : CDD:109739
Taxonomy ID : 10407
Gene Strand (Orientation) : ?
Protein Name : HBs antigen
Protein Length : 159
Protein Note : isolated from serum

Protein Sequence : Show Sequence

>gi|15384573|gb|AAK96425.1|AF360978_1 HBs antigen [Hepatitis B virus]
GTTVCLGQNSQSPTSNHSPTSCPPTCPGYRWMCLRRFIIFLFILLLCLIFLLVLLDYQGMLPVCPLIPGS
STTSTGPCRTCTTPAQGTSMYPSCCCTKPSDGNCTCIPIPSSWAFGKFLWEWASARFSWLSLLVPFVQWF
VGLSPTVWLSVIWMMWYWG

Molecule Role : Other
Related Vaccine(s): Hepatitis B DNA vaccine pCEA/HBsAg encoding CEA and HBsAg , Hepatitis B DNA vaccine pCMV-HBs encoding HBsAg , Hepatitis B DNA vaccine pRc/CMV-HBs(S) encoding HBsAg

5. HBVgp2 pre-S1/pre-S2/S

Gene Name : HBVgp2 pre-S1/pre-S2/S
Sequence Strain (Species/Organism) : Hepatitis B virus
VO ID : VO_0011095
NCBI Gene ID : 944569
NCBI Protein GI : 941241316
Locus Tag : HBVgp2
Genbank Accession : AF372622
Protein Accession : YP_009173869
Other Database IDs : CDD:109739
Taxonomy ID : 10407
Gene Strand (Orientation) : ?
Protein Name : large envelope protein
Protein pI : 8.08
Protein Weight : 41375.3
Protein Length : 389
Protein Note : S gene product, put.surface antigen (AA 1-226)

Protein Sequence : Show Sequence

>YP_009173869.1 large envelope protein [Hepatitis B virus]
MGQNLSTSNPLGFFPDHQLDPAFRANTANPDWDFNPNKDTWPDANKVGAGAFGLGFTPPHGGLLGWSPQA
QGILQTLPANPPPASTNRQSGRQPTPLSPPLRNTHPQAMQWNSTTFHQTLQDPRVRGLYFPAGGSSSGTV
NPVLTTASPLSSIFSRIGDPALNMENITSGFLGPLLVLQAGFFLLTRILTIPQSLDSWWTSLNFLGGTTV
CLGQNSQSPTSNHSPTSCPPTCPGYRWMCLRRFIIFLFILLLCLIFLLVLLDYQGMLPVCPLIPGSSTTS
TGPCRTCMTTAQGTSMYPSCCCTKPSDGNCTCIPIPSSWAFGKFLWEWASARFSWLSLLVPFVQWFVGLS
PTVWLSVIWMMWYWGPSLYSILSPFLPLLPIFFCLWVYI

Molecule Role : Protective antigen
Molecule Role Annotation : Immunisation with a plasmid encoding the DHBV large (L) envelope protein (HBVgp2 pre-S1/pre-S2/S) induced a strong, specific, highly neutralising and long-lasting anti-preS humoral response in uninfected ducks. Importantly, maternal antibodies elicited by such DNA immunisation were vertically transmitted and protected progeny against viral challenge (Thermet et al., 2003).
Related Vaccine(s): Hepatitis B DNA vaccine pCMV-S2.S encoding the HBV(ayw Strain) envelope protein.

6. HBVgp3 X protein

Gene Name : HBVgp3 X protein
Sequence Strain (Species/Organism) : Hepatitis B virus
NCBI Gene ID : 944566
NCBI Protein GI : 21326587
Locus Tag : HBVgp3
Genbank Accession : X04615
Protein Accession : NP_647606
Taxonomy ID : 10407
Gene Starting Position : 1373
Gene Ending Position : 1837
Gene Strand (Orientation) : +
Protein Name : X protein
Protein pI : 8.34
Protein Weight : 15417.45
Protein Length : 154

DNA Sequence : Show Sequence

>gi|21326584:1373-1837 Hepatitis B virus, complete genome
CATGGCTGCTAGGCTGTGCTGCCAACTGGATCCTGCGCGGGACGTCCTTTGTCTACGTCCCGTCGGCGCT
GAATCCCGCGGACGACCCGTCTCGGGGCCGTTTGGGCCTCTACCGTCCCCTTCTTCATCTGCCGTTCCGG
CCGACCACGGGGCGCACCTCTCTTTACGCGGTCTCCCCGTCTGTGCCTTCTCATCTGCCGGACCGTGTGC
ACTTCGCTTCACCTCTGCACGTAGCATGGAGACCACCGTGAACGCCCACCAGGTCTTGCCCAAGGTCTTA
CACAAGAGGACTCTTGGACTCTCAGCAATGTCAACGACCGACCTTGAGGCATACTTCAAAGACTGTTTGT
TTAAAGACTGGGAGGAGTTGGGGGAGGAGATTAGGTTAAAGGTCTTTGTACTAGGAGGCTGTAGGCATAA
ATTGGTCTGTTCACCAGCACCATGCAACTTTTTCCCCTCTGCCTA

Protein Sequence : Show Sequence

>gi|21326587|ref|NP_647606.1| X protein [Hepatitis B virus]
MAARLCCQLDPARDVLCLRPVGAESRGRPVSGPFGPLPSPSSSAVPADHGAHLSLRGLPVCAFSSAGPCA
LRFTSARSMETTVNAHQVLPKVLHKRTLGLSAMSTTDLEAYFKDCLFKDWEELGEEIRLKVFVLGGCRHK
LVCSPAPCNFFPSA

Molecule Role : Virmugen
Molecule Role Annotation : Researchers generated a series of woodchuck hepatitis virus (WHV) X mutants. Woodchucks inoculated with X mutants, including those with no serologic evidence of infection, were protected from later challenge with infectious Woodchuck Hepatitis Virus, suggesting previous infection with resulting protective immunity (Zhang et al., 2001).
Related Vaccine(s): Hepatitis B virus X protein mutant vaccine

7. Large HBsAg

Gene Name : Large HBsAg
Sequence Strain (Species/Organism) : Hepatitis B virus
NCBI Protein GI : 18252577
Other Database IDs : CDD:109739
Taxonomy ID : 10407
Gene Strand (Orientation) : ?
Protein Name : HBsAg
Protein Length : 400
Protein Note : isolated from a HBsAg-positive carrier genotype: c

Protein Sequence : Show Sequence

>gi|18252577|gb|AAL66340.1|AF461363_4 HBsAg [Hepatitis B virus]
MGGWSSKPRQGMGTNLSVPNPLGFFPDHQLDPAFGANSNNPDWDFNPNKDHWPEANQVGAGAFGPGFTPP
HGGLLGWSPQAQGILTTVPVAPPPASTNRQSGRQPTPISPPLRDSHPQAMQWNSTTFHQALLDPRVRGLY
FPAGGSSSGTVNPVPTTASPISSIFSRTGDPAPNMESTTSGFLGPLLVLQAGFFLLTRILTIPQSLDSWW
TSLNFLGGAPTCPGQNSQSPTSNHSPTSCPPICPGYRWMCLRRFIIFLFILLLCLIFLLVLLDYQGMLPV
CPLLPGTSTTSTGPCKTCTSPAQGTSMFPSCCCTKPSDGNCTCIPIPSSWAFARFLWEWASVRFSWLSLL
VPFVQWFVGLSPTVWLSVIWMMWYWGPCLYNILSPFLPLLPIFFCLWVYI

Molecule Role : Other

8. ORF-2

Gene Name : ORF-2
Sequence Strain (Species/Organism) : Hepatitis E virus
NCBI Gene ID : 1494410
NCBI Protein GI : 9626450
Locus Tag : HEVgp10
Genbank Accession : L08816
Protein Accession : NP_056788
Taxonomy ID : 12461
Gene Starting Position : 5122
Gene Ending Position : 7104
Gene Strand (Orientation) : +
Protein Name : capsid protein
Protein pI : 9.05
Protein Weight : 66613.67
Protein Length : 660

DNA Sequence : Show Sequence

>gi|9626440:5122-7104 Hepatitis E virus, complete genome
CATGCGCCCTCGGCCTATTTTGCTGTTGCTCCTCATGTTTCTGCCTATGCTGCCCGCGCCACCGCCCGGT
CAGCCGTCTGGCCGCCGCCGTGGGCGGCGCAGCGGCGGTTCCGGCGGTGGTTTCTGGGGTGACCGGGCTG
ATTCTCAGCCCTTCGCAATCCCCTATATTCATCCAACCAACCCCTTCGCCCCCGATGTCACCGCTGCGGC
CGGGGCTGGACCTCGTGTTCGCCAACCCGCCCGACCACTCGGCTCCGCTTGGCGTGACCAGGCCCAGCGC
CCCGCCGCTGCCTCACGTCGTAGACCTACCACAGCTGGGGCCGCGCCGCTAACCGCGGTCGCTCCGGCCC
ATGACACCCCGCCAGTGCCTGATGTTGACTCCCGCGGCGCCATCCTGCGCCGGCAGTATAACCTATCAAC
ATCTCCCCTTACCTCTTCCGTGGCCACCGGTACAAACTTGGTTCTTTACGCCGCTCCTCTTAGCCCGCTT
CTACCCCTCCAGGACGGCACCAATACTCATATAATGGCTACAGAAGCTTCTAATTATGCCCAGTACCGGG
TTGTTCGTGCTACAATTCGCTACCGCCCGCTGGTCCCCAACGCTGTTGGTGGCTACGCCATCTCCATCTC
GTTCTGGCCACAGACCACCACCACCCCGACGTCCGTTGACATGAATTCAATAACCTCGACTGATGTTCGT
ATTTTAGTCCAGCCCGGCATAGCCTCCGAGCATGTTATCCCAAGTGAGCGCCTACACTATCGTAACCAAG
GTTGGCGCTCTGTTGAGACCTCCGGGGTGGCGGAGGAGGAGGCCACCTCTGGTCTTGTTATGCTTTGCAT
ACATGGCTCACTCGTAAACTCTTATACTAATACACCTTATACCGGTGCCCTCGGGCTGTTGGACTTTGCC
CTCGAACTTGAGTTCCGCAACCTCACCCCCGGTAATACCAACACGCGGGTCTCCCGTTACTCCAGCACTG
CCCGTCACCGCCTTCGTCGCGGTGCAGATGGGACTGCCGAGCTCACCACCACGGCTGCTACCCGCTTCAT
GAAGGACCTCTATTTTACTAGTACTAATGGTGTCGGTGAGATCGGCCGCGGGATAGCGCTTACCCTGTTT
AACCTTGCTGACACCCTGCTTGGCGGTCTACCGACAGAATTGATTTCGTCGGCTGGTGGCCAGCTGTTCT
ACTCTCGCCCCGTCGTCTCAGCCAATGGCGAGCCGACTGTTAAGCTGTATACATCTGTAGAGAATGCTCA
GCAGGATAAGGGTATTGCAATCCCGCATGACATCGACCTCGGGGAATCTCGTGTAGTTATTCAGGATTAT
GATAACCAACATGAGCAGGACCGACCGACACCTTCCCCAGCCCCATCGCGCCCCTTTTCTGTCCTCCGAG
CTAATGATGTGCTTTGGCTTTCTCTCACCGCTGCCGAGTATGACCAGTCCACTTACGGCTCTTCGACCGG
CCCAGTCTATGTCTCTGACTCTGTGACCTTGGTTAATGTAGCGACCGGCGCGCAGGCCGTTGCCCGGTCG
CTCGACTGGACCAAGGTCACACTTGATGGTCGCCCCCTTTCCACCACCCAGCAGTATTCAAAGACCTTCT
TTGTCCTGCCGCTCCGCGGTAAGCTCTCCTTTTGGGAGGCAGGTACTACTAAAGCCGGGTACCCTTATAA
TTATAACACCACTGCTAGTGACCAACTGCTCGTTGAGAATGCCGCTGGGCATCGGGTTGCTATTTCCACT
TACACCACTAGCCTGGGTGCTGGCCCCGTCTCTATTTCCGCGGTTGCTGTTTTAGCCCCCCACTCTGCGC
TAGCATTGCTTGAGGATACCATGGACTACCCTGCCCGCGCCCATACTTTCGATGACTTCTGCCCGGAGTG
CCGCCCCCTTGGCCTCCAGGGCTGTGCTTTTCAGTCTACTGTCGCTGAGCTTCAGCGCCTTAAGATGAAG
GTGGGTAAAACTCGGGAGTTATA

Protein Sequence : Show Sequence

>gi|9626450|ref|NP_056788.1| capsid protein [Hepatitis E virus]
MRPRPILLLLLMFLPMLPAPPPGQPSGRRRGRRSGGSGGGFWGDRADSQPFAIPYIHPTNPFAPDVTAAA
GAGPRVRQPARPLGSAWRDQAQRPAAASRRRPTTAGAAPLTAVAPAHDTPPVPDVDSRGAILRRQYNLST
SPLTSSVATGTNLVLYAAPLSPLLPLQDGTNTHIMATEASNYAQYRVVRATIRYRPLVPNAVGGYAISIS
FWPQTTTTPTSVDMNSITSTDVRILVQPGIASEHVIPSERLHYRNQGWRSVETSGVAEEEATSGLVMLCI
HGSLVNSYTNTPYTGALGLLDFALELEFRNLTPGNTNTRVSRYSSTARHRLRRGADGTAELTTTAATRFM
KDLYFTSTNGVGEIGRGIALTLFNLADTLLGGLPTELISSAGGQLFYSRPVVSANGEPTVKLYTSVENAQ
QDKGIAIPHDIDLGESRVVIQDYDNQHEQDRPTPSPAPSRPFSVLRANDVLWLSLTAAEYDQSTYGSSTG
PVYVSDSVTLVNVATGAQAVARSLDWTKVTLDGRPLSTTQQYSKTFFVLPLRGKLSFWEAGTTKAGYPYN
YNTTASDQLLVENAAGHRVAISTYTTSLGAGPVSISAVAVLAPHSALALLEDTMDYPARAHTFDDFCPEC
RPLGLQGCAFQSTVAELQRLKMKVGKTREL

Molecule Role : Other

9. PreS2+S (Middle protein)

Gene Name : PreS2+S (Middle protein)
Sequence Strain (Species/Organism) : Hepatitis B virus strain ayw
NCBI Protein GI : 71794216
Other Database IDs : CDD:279085
Taxonomy ID : 10407
Gene Strand (Orientation) : ?
Protein pI : 8.03
Protein Weight : 30302.9
Protein Length : 343
Protein Note : Major surface antigen from hepadnavirus; pfam00695

Protein Sequence : Show Sequence

>CAJ21096.1 unnamed protein product [Hepatitis B virus]
MQWNSTTFHQTLQDPRVRGLYFPAGGSSSGTVNPVLTTASPLSSIFSRIGDPALNMENITSGFLGPLLVL
QAGFFLLTRILTIPQSLDSWWTSLNFLGGTTVCLGQNSQSPTSNHSPTSCPPTCPGYRWMCLRRFIIFLF
ILLLCLIFLLVLLDYQGMLPVCPLIPGSSTTSTGPCRTCMTTAQGTSMYPSCCCTKPSDGNCTCIPIPSS
WAFGKFLWEWASARFSWLSLLVPFVQWFVGLSPTVWLSVIWMMWYWGPSLYSILSPFLPLLPIFFCLWVY
I

Molecule Role : Protective antigen
Related Vaccine(s): Hepatitis B DNA vaccine pCMV-S2.S encoding the HBV(ayw Strain) envelope protein.

10. S

Gene Name : S
Sequence Strain (Species/Organism) : Hepatitis B virus strain MonB04-059
VO ID : VO_0011093
NCBI Protein GI : 128168861
Other Database IDs : CDD:279085
Taxonomy ID : 10407
Gene Strand (Orientation) : ?
Protein Name : hepatitis B surface antigen
Protein pI : 8.11
Protein Weight : 14446.5
Protein Length : 204
Protein Note : genotype D

Protein Sequence : Show Sequence

>BAF48754.1 hepatitis B surface antigen, partial [Hepatitis B virus]
NFLGGTTVCLGQNSQSPTSNHSPTSCPPTCPGYRWMCLRRFIIFLFILLLCLIFLLVLLDYQGMLPVCPL
IPGSSTTSTGPCRTCTTPAQGTSMYPSCCCTKPSDGNCTCIPIPSSWAFGKFLWEWASARFS

Molecule Role : Protective antigen
Molecule Role Annotation : Study compared a current HBV vaccine that contains recombinant hepatitis B surface antigen HBsAg) adsorbed to alum in chimpanzees, with two novel vaccine strategies that have proven superior to the current vaccine in mice. All animals receiving either control or CpG-containing subunit vaccines at 0 and 4 weeks attained titers of HBsAg-specific antibody (anti-HBs) considered protective (> or =10 mIU/ml) and were indeed protected from challenge at 8 weeks with 10(3.5) 50% chimp infectious doses (CID(50)) of intravenous HBV (Payette et al., 2006).

11. S

Gene Name : S
Sequence Strain (Species/Organism) : Hepatitis B virus subtype adr
NCBI Protein GI : 267364
Other Database IDs : CDD:279085
Taxonomy ID : 31513
Gene Strand (Orientation) : ?
Protein Name : Small envelope protein
Protein pI : 8.05
Protein Weight : 27882.11
Protein Length : 425
Protein Note : S glycoprotein; S-HBsAg; Small S protein; Small surface protein; SHB

Protein Sequence : Show Sequence

>sp|P30019.1|HBSAG_HBVC6 RecName: Full=Small envelope protein; AltName: Full=S glycoprotein; AltName: Full=S-HBsAg; Short=SHB; AltName: Full=Small S protein; AltName: Full=Small surface protein
MENTASGFLGPLLVLQAGFFLLTRILTIPQSLDSWWTSLNFLGGAPTCPGQNSQSPTSNHSPTSCPPICP
GYRWMCLRRFIIFLFILLLCLIFLLVLLDYHGMLPVCPLLPGTSTTSTGPCKTCTIPAQGTSMFPSCCCT
KPSDGNCTCIPIPSSWAFARFLWEWASVRFSWLSLLVPFVQWFVGLSPTVWLSVIWMMWYWGPSLYNILS
PFLPLLPIFFCLWVYI

Molecule Role : Protective antigen
Related Vaccine(s): Hepatitis B DNA vaccine PLGA–CTAB–DNA encoding the small envelope gene

12. S

Gene Name : S
Sequence Strain (Species/Organism) : Duck hepatitis B virus strain GD3
NCBI Protein GI : 44829150
Other Database IDs : CDD:279085
Taxonomy ID : 12639
Gene Strand (Orientation) : ?
Protein Name : S protein
Protein pI : 8.85
Protein Weight : 18126.11
Protein Length : 218
Protein Note : Major surface antigen from hepadnavirus; pfam00695

Protein Sequence : Show Sequence

>AAS47829.1 S protein [Duck hepatitis B virus]
MSGTFGGILAGLIGLLVSFFLLIKILEILRRLDWWWISLSSPKGKMQCAFQETGAQTSPHYVGSCPWGCP
GFLWTYLRLFIIFLLILLVAAGLLYLTDNGSTILGKLQWASVSALFSSISSLLPSDQKSLVALMFGLLLI
WMTSSSATQTLVTLTQLATLSALFYKS

Molecule Role : Protective antigen
Related Vaccine(s): Duck hepatitis B DNA vaccine pcDNA I-S encoding small S proteins

13. S

Gene Name : S
Sequence Strain (Species/Organism) : Hepatitis B virus strain ayw
NCBI Protein GI : 461940451
Other Database IDs : CDD:279085
Taxonomy ID : 10407
Gene Strand (Orientation) : ?
Protein Name : small S protein
Protein pI : 7.86
Protein Weight : 24765.13
Protein Length : 279
Protein Note : genotype: B

Protein Sequence : Show Sequence

>AGH20418.1 small S protein [Hepatitis B virus]
MENISSGLLGPLLVLQAGFFLLTKILTIPQSLDSWWTSLNFLGGTPVCLGQNSQSQISSHSPTCCPPTCP
GYRWMCLRRFIIFLCILLLCLIFLLVLLDYQGMLPVCPLIPGSSTTSTGPCRTCTTPAQGTSLFPSCCCT
KPTDGNCTCIPIPSSWAFAKYLWEWASVRFSWLSLLVPFVQWFVGHSPTVWLSVIWMMWFWGPSLYNILS
PFIPLLPIFFCLWVYI

Molecule Role : Protective antigen
Related Vaccine(s): Hepatitis B DNA vaccine pCMV-S2.S encoding the HBV(ayw Strain) envelope protein.

14. S

Gene Name : S
Sequence Strain (Species/Organism) : Duck hepatitis B virus isolate CH6
NCBI Protein GI : 169116569
Other Database IDs : CDD:279085
Taxonomy ID : 12639
Gene Strand (Orientation) : ?
Protein Name : large S protein
Protein pI : 8.31
Protein Weight : 39801.32
Protein Length : 427
Protein Note : Major surface antigen from hepadnavirus; pfam00695

Protein Sequence : Show Sequence

>ACA42588.1 large S protein [Duck hepatitis B virus]
MKQESFISGYLNIWSHLKVSLIIGNSNTLSINITFMMGQHPAKSMDVRRIEGGEILLNQLAGRMIPKGTL
TWSGKFPTLDHVLDHVQTMEEINTLQNQGAWPAGAGRRVGLSNPTPQEIPQPQWTPEEDQKAREAFRRYQ
EERPPETTTIPPSSPPQWKLQPGDDPLLGNQSLLETHPLYQYTEPEPAVPVIKTPPLKKKMSGTFGGILA
GLIGLLVSFFLLIKILEILRRLDWWWISLSSPKGKMQCAFQDTGAQISPHYVGSCPWGCPGFLWTYLRLF
IIFLLILLVAAGLLYLTDNGSTILGKLQWASVSALFSSISSLLPSDPKSLVALTFGLSLIWMTSSSATQT
LVTLTQLVTLSALFYKS

Molecule Role : Protective antigen
Related Vaccine(s): Hepatitis B virus DNA vaccine encoding HBVgp2 pre-S1/pre-S2/S

III. Vaccine Information

1. COMVAX

a. Product Name:

Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine

b. Tradename:

COMVAX

c. Manufacturer:

Merck & Co., Inc

d. Vaccine Ontology ID:

VO_0000028

e. CDC CVX code:

f. Type:

Conjugate vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #0002)

i. Host Species for Licensed Use:

Human

j. Immunization Route

Intramuscular injection (i.m.)

k. Storage

Store vaccine at 2-8°C (36-46*F). Storage above or belew the recommended temperature may reduce potency. DO NOT FREEZE since freezing destroys potency (FDA COMVAX).

2. Duck hepatitis B DNA vaccine pcDNA I-S encoding small S proteins

a. Vaccine Ontology ID:

VO_0004353

b. Type:

DNA vaccine

c. Status:

Research

d. Host Species as Laboratory Animal Model:

Duck

e. Antigen

S protein from DHBV Australian strain (Triyatni et al., 1998)

f. Gene Engineering of S

Type: DNA vaccine construction
Description:
Detailed Gene Information: Click here.

g. Vector:

pcDNA I/Amp (Triyatni et al., 1998)

h. Immunization Route

Intramuscular injection (i.m.)

i. Ducks Response

Vaccine Immune Response Type: VO_0000286
Immune Response: The S-DNA vaccine was able to elicit humoral immune responses against DHBV surface proteins in ducks. In addition, The S-DNA vaccine induced high titers of anti-DHBs antibodies, and anti-S antibodies induced by the S-DNA construct were highly effective in neutralizing virus infectivity. (Triyatni et al., 1998).
Efficacy: Vaccination of ducks with S DNA vaccines prevented the development of viremia following virus challenge. All ducks were challenged with a high-titer dose of DHBV virus. Preincubation of the virus with 5, 10, or, 20 μl of anti-S serum at 37°C for 1 hour prior to i.v. inoculation into 1-day-old ducklings completely prevented the development of viremia during a 4-week observation period in all of the ducks (Triyatni et al., 1998).

3. Engerix-B

a. Product Name:

Hepatitis B Vaccine (Recombinant)

b. Tradename:

Engerix-B

c. Manufacturer:

GlaxoSmithKline Biologicals

d. Vaccine Ontology ID:

VO_0010711

e. CDC CVX code:

08, 44

f. Type:

Subunit vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #1617)

i. Host Species for Licensed Use:

Human

j. Antigen

Hepatitis B surface antigen

k. Adjuvant:

VO ID: VO_0000127

l. Preparation

ENGERIX-B contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The surface antigen expressed in Saccharomyces cerevisiae cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. Each 0.5-mL dose contains 10 mcg of hepatitis B surface antigen adsorbed on 0.25 mg aluminum as aluminum hydroxide (FDA: ENGERIX-B).

m. Storage

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze.

n . Approved Age for Licensed Use

All ages

o. Contraindication

ENGERIX-B should not be administered to anyone with known hypersensitivity to any component of the vaccine, including yeast and any previous hypersensitivity to any hepatitis B-containing vaccine.

p. Description

ENGERIX-B is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It is manufactured by GlaxoSmithKline Biologicals. It is licensed for human use in USA (FDA: ENGERIX-B).

q. Human Response

Vaccination Protocol: Many clinical trials were conducted on subjects ranging in ages from 6 months old to 65 years.
Side Effects: Side Effects of vaccination with ENGERIX-B include: redness, swelling and pain of the injection site, fever, headache and dizziness

4. HBsAg Liposomal MTP-PE Vaccine

a. Vaccine Ontology ID:

VO_0004239

b. Type:

Subunit vaccine

c. Status:

Research

d. Antigen

HBsAg (Jain et al., 2009).

e. Adjuvant:

VO ID: VO_0001302

f. Immunization Route

Intramuscular injection (i.m.)

g. Mouse Response

Host Strain: Swiss
Vaccination Protocol: Alum-adsorbed antigen, liposomes (with or without MTP-PE and with or without MDP-GDP) with HBsAg antigen or liposomes (with or without MTP-PE and with or without MDP-GDP) without HBsAg antigen, in a dose equivalent to 10 μg HBsAg were injected intramuscularly and recombinant pure HBsAg was used as control. The immunomodulator doses given with each injection were 20 μg of MTP-PE and 10 μg of MDP-GDP. Secondary immunization was done after 4 weeks with the same formulations (Jain et al., 2009).
Immune Response: The incorporation of MTP-PE on the liposomal HBsAg increased the stimulation index (SI) four to five times as compared to plain HBsAg solution, and it also induced significantly higher Th1 cellular immune response with a predominant IFN-γ level (Jain et al., 2009).

5. HBVAXPRO

a. Manufacturer:

(Sanofi Pasteur MSD

b. Type:

Recombinant vector vaccine

c. Status:

Licensed

d. Location Licensed:

France

e. Host Species for Licensed Use:

Human

f. Antigen

hepatitis B surface antigen

g. Immunization Route

Intramuscular injection (i.m.)

h . Approved Age for Licensed Use

Patients aged ≥18 years.

i. Description

HBVAXPRO Is a recombinant vector vaccine with a single adjuvant HBV vaccine with aluminium hydroxyphosphate sulfate administered intramuscularly in the deltoid muscle. (Horta et al., 2022)

j. Human Response

Vaccination Protocol: Patients were vaccinated with HBVAXPRO® 40 at 0, 1 and 6 months (Horta et al., 2022).
Efficacy: The results of our study show that HBVAXPRO is effective and safe in patients with chronic liver disease.

6. Hepatitis B DNA vaccine pCEA/HBsAg encoding CEA and HBsAg

a. Vaccine Ontology ID:

VO_0004359

b. Type:

DNA vaccine

c. Status:

Research

d. Host Species as Laboratory Animal Model:

Human

e. Gene Engineering of HbS

Type: DNA vaccine construction
Description: Vector pcDNA3 expressed carcinoembryonic antigen (CEA) and hepatitis B surface antigen (HBsAg) (Conry et al., 2002).
Detailed Gene Information: Click here.

f. Vector:

pcDNA3 (Conry et al., 2002)

g. Immunization Route

Intramuscular injection (i.m.)

h. Human Response

Vaccine Immune Response Type: VO_0000286
Immune Response: CEA-specific antibody and lymphoproliferative responses have been reported after vaccination with an anti-idiotype monoclonal antibody mimicking a portion of the CEA molecule in patients with colorectal carcinoma (Conry et al., 2002).
Efficacy: Repetitive dosing of pCEA/HBsAg induced HBsAg antibodies in 6 of 8 patients, with protective antibody levels achieved in 4 of these patients. (Conry et al., 2002).

7. Hepatitis B DNA vaccine pCMV-HBs encoding HBsAg

a. Vaccine Ontology ID:

VO_0004358

b. Type:

DNA vaccine

c. Status:

Research

d. Host Species as Laboratory Animal Model:

Mouse

e. Gene Engineering of HbS

Type: DNA vaccine construction
Description: Vector pCMV expressed HBV surface antigen (HBsAg) (Davis et al., 1993).
Detailed Gene Information: Click here.

f. Vector:

pCMV (Davis et al., 1993)

g. Immunization Route

Intramuscular injection (i.m.)

h. Mouse Response

Vaccine Immune Response Type: VO_0000286
Immune Response: The serum concentration of secreted HBsAg after a one-time injection of DNA was sufficient to induce the production of anti-HBsAg 10 days after injection, and the antibody levels continued to increase for up to at least 60 days. Direct intramuscular injection of the plasmid vector encoding the HBsAg leads to secretion of the viral surface protein into the circulation, in the form of empty particles (Davis et al., 1993).
Efficacy: A level of 10 mlU/ml of anti-HBsAg antibody is recognized as being sufficient in humans to confer protection against natural Hepatitis B virus infection. This level of antibody response was achieved in 68% of mice vaccinated with the vaccine candidate at two weeks after vaccination. By 8 wks, all mice had >100 mIU anti-HBsAg in their sera, suggesting sufficient vaccine efficacy (Davis et al., 1993).

8. Hepatitis B DNA vaccine pCMV-S2.S encoding the HBV(ayw Strain) envelope protein.

a. Vaccine Ontology ID:

VO_0004360

b. Type:

DNA vaccine

c. Status:

Research

d. Host Species as Laboratory Animal Model:

Chimpanzee

e. Gene Engineering of PreS2+S (Middle protein)

Type: DNA vaccine construction
Description:
Detailed Gene Information: Click here.

f. Gene Engineering of S

Type: DNA vaccine construction
Description:
Detailed Gene Information: Click here.

g. Vector:

pcDNA3 (Davis et al., 1996)

h. Immunization Route

Intramuscular injection (i.m.)

i. Chimpanzee Response

Vaccine Immune Response Type: VO_0000286
Immune Response: Immunization of chimpanzees with HBsAg-expressing plasmid DNA induced specific anti-HBs antibodies. The higher dose of DNA (2 mg) induced significant titers (>100 mIU/ml) of anti-HBs after the initial injection of DNA. These titers never went below the 10 mIU/ml level considered adequate to confer protection (Davis et al., 1996).
Efficacy: The outcome of challenge with live HBV of the ayw strain was strongly correlated with the anti-HBs titers. Of the eight chimpanzees with a titer >10 mIU/ml, all were protected from infection except for one, which had the lowest anti-HBs titer at 12 mIU/ml. These findings agree closely with the critical protective level of 10 mIU/ml determined for humans by the Centers for Disease Control (Davis et al., 1996).

9. Hepatitis B DNA vaccine PLGA–CTAB–DNA encoding the small envelope gene

a. Vaccine Ontology ID:

VO_0004352

b. Type:

DNA vaccine

c. Status:

Research

d. Host Species as Laboratory Animal Model:

Mouse

e. Gene Engineering of S

Type: DNA vaccine construction
Description: Vector pVAX(S) expressed the small envelope gene of HBV (He et al., 2005).
Detailed Gene Information: Click here.

f. Vector:

pVAX(S), derived from pVAX1 (He et al., 2005)

g. Immunization Route

Intramuscular injection (i.m.)

h. Mouse Response

Vaccine Immune Response Type: VO_0000286
Immune Response: PLGA–CTAB–DNA optimizes two key features during antigen presentation, controlled release and targeted delivery, which might be involved in the mechanisms of its augmented immunogenicity and enhanced immunoprotection (He et al., 2005)
Challenge Protocol: Challenge with transplanted HBsAg-expressing tumor cells (He et al., 2005).
Efficacy: Mice immunized with PLGA–CTAB–pVAX(S) (20 μg per mouse) or naked pVAX(S) (100 μg per mouse) after a challenge of transplanted HBsAg-expressing tumor cells showed weak protection efficacy, resulting in a final survival rate of 10% or 20% at week 15. However, mice immunized with PLGA–CTAB–pVAX(S) at the dose of 100 μg per mouse displayed a strong inhibition on tumor formation and a remarkable improvement in final survival rate (60%) (He et al., 2005).

10. Hepatitis B DNA vaccine pRc/CMV-HBs(S) encoding HBsAg

a. Vaccine Ontology ID:

VO_0004354

b. Type:

DNA vaccine

c. Status:

Research

d. Host Species as Laboratory Animal Model:

Mouse

e. Gene Engineering of HbS

Type: DNA vaccine construction
Description: This DNA vaccine expressed the HBV surface antigen (HBsAg) (Khatri et al., 2008).
Detailed Gene Information: Click here.

f. Vector:

pCMV-S (Khatri et al., 2008)

g. Immunization Route

intranasal immunization

h. Mouse Response

Vaccine Immune Response Type: VO_0000286
Immune Response: When mice are immunized with recombinant HBsAg, the main type of immune response generated is the antibody response. However, a Th1/CTL response was also elicited, which is important to facilitate eradication of HBV infection and can be utilized for therapeutic immunization of HBV chronic carriers (Khatri et al., 2008).
Efficacy: Nasal administration of nanoparticles resulted in serum anti-HBsAg titre that was less compared to that elicited by naked DNA and alum adsorbed HBsAg, but the mice were seroprotective within 2 weeks and the immunoglobulin level was above the clinically protective level (>10 mIU/ml) suggesting successful generation of systemic immunity. Levels of 1 and 10 mIU/ml are well-established standards for anti-HBs antibody levels in mice and humans, respectively and are considered sufficient to confer protection against the disease (Khatri et al., 2008).

11. Hepatitis B DNA vaccine pS encoding major envelope proteins

a. Vaccine Ontology ID:

VO_0004357

b. Type:

DNA vaccine

c. Status:

Research

d. Host Species as Laboratory Animal Model:

Mouse

e. Gene Engineering of Envelope proteins

Type: DNA vaccine construction
Description: Vector pcDNA3 expressed HBV major envelope proteins (Chow et al., 1998).
Detailed Gene Information: Click here.

f. Vector:

pcDNA3 (Chow et al., 1998)

g. Immunization Route

Intramuscular injection (i.m.)

h. Mouse Response

Vaccine Immune Response Type: VO_0000286
Immune Response: Coexpression of IL-2 and hepatitis B virus HBV^3 envelope protein within the same plasmid vector resulted in a dramatic increase in its ability to induce humoral and cellular immune responses to HBsAg. Also, the IL-2 adjuvant activity helps the HBV DNA vaccine elicit high anti-HBs titers in animals that usually fail to respond to rHBsAg vaccination (Chow et al., 1998)
Efficacy: Four of five mice immunized with pS + pcDNA3 and challenged with CT26/S showed an inhibition of tumor growth. The protective efficacy was dramatically increased when the IL-12 gene was coinjected with plasmid pS because tumor growth was significantly suppressed, and two of five mice remained tumor free up to 60 days following tumor challenge (Chow et al., 1998).

12. Hepatitis B surface antigen (HBsAg) with JVRS-1000

a. Vaccine Ontology ID:

VO_0004260

b. Type:

Subunit vaccine

c. Status:

Research

d. Antigen

Hepatitis B surface antigen (HBsAg) (Morrey et al., 2011).

e. Adjuvant:

VO ID: VO_0001339

f. Immunization Route

Intramuscular injection (i.m.)

g. Mouse Response

Host Strain: C57BL/6
Vaccination Protocol: HBV transgenic mice were vaccinated with HBsAg (i.m., 5 μg), or HBsAg plus JVRS-100 (i.v., 10 μg) in female C57BL/6 mice (>6 weeks). Animals were treated on days 1, 22, and 43 (Morrey et al., 2011).
Immune Response: JVRS-100 combined with hepatitis B surface antigen (HBsAg) broke tolerance by stimulating significant B and T cell responses. The combination of HBsAg + JVRS-100 elicited a T cell response as indicated by increased levels of IFN-γ in splenocyte cell-culture supernatant (Morrey et al., 2011).

13. Hepatitis B virus DNA vaccine encoding HBVgp2 pre-S1/pre-S2/S

a. Vaccine Ontology ID:

VO_0011411

b. Type:

DNA vaccine

c. Status:

Research

d. Antigen

Hepatitis B virus HBVgp2 pre-S1/pre-S2/S

e. Gene Engineering of S

Type: DNA vaccine construction
Description: The pCI expression vector (Promega, Charbonières, France) was used to clone the entire DHBV large envelope gene into Not I polylinker site leading to the pCI-preS/S plasmid [5] and the DHBV core gene leading to pCI-C plasmid (Thermet, submitted). The pCI-preS/S, pCI-C and the native pCI plasmids were purified by Endotoxin Free Giga prep (Qiagen, Hilden, Germany) (Thermet et al., 2003).
Detailed Gene Information: Click here.

f. Vector:

pCI expression vector (Promega, Charbonières, France)

g. Immunization Route

Intramuscular injection (i.m.)

h. Ducks Response

Host Strain: Pekin
Vaccination Protocol: Four-week-old ducks received intramuscular (i.m.) injections of 100–300 μg of plasmid DNA diluted in NaCl 0.9%. The birds were injected in three sites (anterior quadriceps of both legs and breast), and booster doses were given 3 weeks later at the same sites (Thermet et al., 2003).
Challenge Protocol: Progeny ducklings received a high titre DHBV challenge and the viremia was followed by quantitative dot blot hybridisation for each animal during 17 days (Thermet et al., 2003).
Efficacy: Immunisation with a plasmid encoding the DHBV large (L) envelope protein (HBVgp2 pre-S1/pre-S2/S) induced a strong, specific, highly neutralising and long-lasting anti-preS humoral response in uninfected ducks. Importantly, maternal antibodies elicited by such DNA immunisation were vertically transmitted and protected progeny against viral challenge (Thermet et al., 2003).

14. Hepatitis B virus DNA vaccine pVAX-PS

a. Vaccine Ontology ID:

VO_0011404

b. Type:

DNA vaccine

c. Status:

Research

d. Antigen

Hepatitis B virus preS2 middle surface protein

e. Gene Engineering of envelope

Type: DNA vaccine construction
Description: pVAXPS was constructed by inserting the gene encoding the middle (pre-S2 plus S) envelope protein of HBV into a plasmid vector pVAX1 (Zhou et al., 2003).
Detailed Gene Information: Click here.

f. Vector:

Plasmid vector pVAX1

g. Immunization Route

Intramuscular injection (i.m.)

h. Tree shrew Response

Vaccination Protocol: Sixty adult tree shrews purchased from the Kunming Animal Institute were randomly divided into four groups and immunized twice at 2-week intervals with the DNA vaccine by i.m. injection of 100 mg of pVAX-PS or pVAX1 in a volume of 100 ml in bilateral quadriceps (Zhou et al., 2003).
Challenge Protocol: Two weeks after the second DNA immunization, tree shrews in two groups (immunized with pVAX-PS and pVAX1, respectively) were challenged through the caudal vein with 0.8 ml of the patient’s serum positive for the HBV marker (Zhou et al., 2003).
Efficacy: The immunological protection of pVAX-PS, a DNA vaccine, was assessed in the tree shrews model. pVAX-PS was constructed by inserting the gene encoding the middle (pre-S2 plus S) envelope protein of HBV into a plasmid vector pVAX1. Results indicated that pVAX-PS immunization could induce remarkable humoral immune response and prevent the experimental tree shrews from infection of HBV (Zhou et al., 2003).

15. Hepatitis B virus X protein mutant vaccine

a. Vaccine Ontology ID:

VO_0002969

b. Type:

Live, attenuated vaccine

c. Status:

Research

d. Host Species as Laboratory Animal Model:

Woodchuck

e. Gene Engineering of HBVgp3 X protein

Type: Gene mutation
Description: .This X protein is from Hepatitis B virus (Zhang et al., 2001).
Detailed Gene Information: Click here.

f. Immunization Route

Intrahepatic immunization

g. Woodchuck Response

Persistence: An X protein mutant is attenuated in woodchucks (Zhang et al., 2001).
Efficacy: An X protein mutant induces significant protection in woodchucks from challenge with wild type Hepatitis B virus (Zhang et al., 2001).

16. Infanrix-hexa

a. Product Name:

Combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis and adsorbed conjugated Haemophilus influenzae type b vaccine

b. Tradename:

Infanrix-hexa

c. Manufacturer:

GlaxoSmithKline

d. Vaccine Ontology ID:

VO_0010719

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

j. Adjuvant:

VO ID: VO_0000128

k. Preservative:

2 phenoxy ethanol

l. Allergen:

Polymyxin B Neomycin, Latex in plunger stopper of prefilled syringe

m. Immunization Route

Intramuscular injection (i.m.)

n. Storage

Should be stored at 2° to 8°C (35° to 46°F).

o . Approved Age for Licensed Use

Under 7 years of age.

p. Description

Products: Proteins + killed viruses + conjugate. Other components: Yeast protein Formaldehyde, Lactose, Polysorbate 20 and 80.

17. Pediarix

a. Product Name:

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined

b. Tradename:

Pediarix

c. Manufacturer:

GlaxoSmithKline

d. Vaccine Ontology ID:

VO_0000082

e. CDC CVX code:

110

f. Type:

Subunit vaccine + Inactivated or "killed" vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #1617), Canada

i. Host Species for Licensed Use:

Human

j. Adjuvant:

VO ID: VO_0000127

k. Preservative:

2 phenoxy ethanol

l. Allergen:

Polymyxin B Neomycin, Latex in plunger stopper of prefilled syringe

m. Immunization Route

Intramuscular injection (i.m.)

n. Storage

The vaccine should be refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze.

o . Approved Age for Licensed Use

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 as a three-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age. PEDIARIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older (FDA: Pediarix).

p. Description

Products: Proteins + killed virus. Other components: Yeast protein Formaldehyde, Polysorbate 80.

18. recombinant S gene Hepatitis B Vaccine with rIFN-gamma

a. Vaccine Ontology ID:

VO_0004251

b. Type:

Subunit vaccine

c. Status:

Research

d. Antigen

Recombinant S gene of hepatitis B (Quiroga et al., 1990).

e. Adjuvant:

VO ID: VO_0001296

f. Immunization Route

Intramuscular injection (i.m.)

g. Human Response

Vaccination Protocol: 81 adult white hemodialysis patients (46 men, 35 women aged 19-65 yrs) with no serological evidence of immunity to hepatitis B were used in the study. Patients were randomly allocated to one of two groups. Group I comprised 41 patients who recieved 40μg of recombinant (S gene) hepatitis B vaccine by i.m. injection and 0,1, and 6 months. Group II comprised 40 patients who received 40 μg of recombinant (S gene) hepatitis B vaccine given intramuscularly with 2 million units (MU) of rIFN-gamma/m^2 body surface given subcutaneously at 0,1, and 6 months (Quiroga et al., 1990).
Immune Response: The titers of anti-HBs achieved among patients who received vaccine and rIFN-gamma were higher than among those receiving the vaccine alone (Quiroga et al., 1990).

19. Recombivax HB

a. Product Name:

Hepatitis B Vaccine (Recombinant)

b. Tradename:

Recombivax HB

c. Manufacturer:

Merck & Co, Inc

d. Vaccine Ontology ID:

VO_0010737

e. CDC CVX code:

08, 43,

f. Type:

Subunit vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #0002)

i. Host Species for Licensed Use:

Human

j. Antigen

Hepatitis B surface antigen (HBsAg) produced in yeast cells.

k. Adjuvant:

VO ID: VO_0000127

l. Preparation

RECOMBIVAX HB is a sterile suspension for intramuscular injection. It is a non-infectious subunit viral vaccine derived from hepatitis B surface antigen (HBsAg) produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories. The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg (Merck: Recombivax HB).

m. Storage

Store vials and syringes at 2-8°C (36-46°F). Do not freeze.

n . Approved Age for Licensed Use

All ages

o. Contraindication

RECOMBIVAX-HB should not be administered to anyone with a known hypersensitivity to yeast or any component of the vaccine.

p. Human Response

Side Effects: Side effects included: pain, redness and swelling of the injection site, fatigue, fever, headache and nausea.

20. 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.

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

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: TWINRIX).

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.

21. 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 (FDA: TWINRIX)

n. Description

Products: Recombinant protein + killed virus. Other components: Yeast protein Formaldehyde, Polysorbate 20.

IV. References

1. Chen et al., 2011: Chen JH, Yu YS, Liu HH, Chen XH, Xi M, Zang GQ, Tang ZH. Ubiquitin conjugation of hepatitis B virus core antigen DNA vaccine leads to enhanced cell-mediated immune response in BALB/c mice. Hepatitis monthly. 2011; 11(8); 620-628. [PubMed: 22140385].

2. Chow et al., 1998: Chow YH, Chiang BL, Lee YL, Chi WK, Lin WC, Chen YT, Tao MH. Development of Th1 and Th2 populations and the nature of immune responses to hepatitis B virus DNA vaccines can be modulated by codelivery of various cytokine genes. Journal of immunology (Baltimore, Md. : 1950). 1998; 160(3); 1320-1329. [PubMed: 9570550].

3. Conry et al., 2002: Conry RM, Curiel DT, Strong TV, Moore SE, Allen KO, Barlow DL, Shaw DR, LoBuglio AF. Safety and immunogenicity of a DNA vaccine encoding carcinoembryonic antigen and hepatitis B surface antigen in colorectal carcinoma patients. Clinical cancer research : an official journal of the American Association for Cancer Research. 2002; 8(9); 2782-2787. [PubMed: 12231517].

4. Davis et al., 1993: Davis HL, Michel ML, Whalen RG. DNA-based immunization induces continuous secretion of hepatitis B surface antigen and high levels of circulating antibody. Human molecular genetics. 1993; 2(11); 1847-1851. [PubMed: 8281146].

5. Davis et al., 1996: Davis HL, McCluskie MJ, Gerin JL, Purcell RH. DNA vaccine for hepatitis B: evidence for immunogenicity in chimpanzees and comparison with other vaccines. Proceedings of the National Academy of Sciences of the United States of America. 1996; 93(14); 7213-7218. [PubMed: 8692971].

6. FDA COMVAX: FDA COMVAX package insert information [http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM109869.pdf]

7. FDA: COMVAX: FDA: COMVAX [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm174757.htm]

8. FDA: ENGERIX-B: FDA: ENGERIX-B I [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm110102.htm]

9. FDA: Pediarix: FDA: Pediarix [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm146759.htm]

10. FDA: RECOMBIVAX HB: FDA: RECOMBIVAX HB [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm110098.htm]

11. FDA: TWINRIX: FDA: TWINRIX [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094035.htm]

12. Hwang et al., 2002: Hwang YK, Kim NK, Park JM, Lee K, Han WK, Kim HI, Cheong HS. HLA-A2 1 restricted peptides from the HBx antigen induce specific CTL responses in vitro and in vivo. Vaccine. 2002; 20(31-32); 3770-3777. [PubMed: 12399208].

13. Jain et al., 2009: Jain V, Vyas SP, Kohli DV. Well-defined and potent liposomal hepatitis B vaccines adjuvanted with lipophilic MDP derivatives. Nanomedicine : nanotechnology, biology, and medicine. 2009; 5(3); 334-344. [PubMed: 19523433].

14. Khatri et al., 2008: Khatri K, Goyal AK, Gupta PN, Mishra N, Vyas SP. Plasmid DNA loaded chitosan nanoparticles for nasal mucosal immunization against hepatitis B. International journal of pharmaceutics. 2008; 354(1-2); 235-241. [PubMed: 18182259].

15. KuhrÃ¶ber et al., 1997: KuhrÃ¶ber A, Wild J, Pudollek HP, Chisari FV, Reimann J. DNA vaccination with plasmids encoding the intracellular (HBcAg) or secreted (HBeAg) form of the core protein of hepatitis B virus primes T cell responses to two overlapping Kb- and Kd-restricted epitopes. International immunology. 1997; 9(8); 1203-1212. [PubMed: 9263018].

16. Kwissa et al., 2003: Kwissa M, KrÃ¶ger A, Hauser H, Reimann J, Schirmbeck R. Cytokine-facilitated priming of CD8+ T cell responses by DNA vaccination. Journal of molecular medicine (Berlin, Germany). 2003; 81(2); 91-9101. [PubMed: 12601525].

17. Merck: Recombivax HB: Merck: Recombivax HB vaccine information [http://www.merck.com/product/usa/pi_circulars/r/recombivax_hb/recombivax_pi.pdf]

18. Morrey et al., 2011: Morrey JD, Motter NE, Chang S, Fairman J. Breaking B and T cell tolerance using cationic lipid-DNA complexes (CLDC) as a vaccine adjuvant with hepatitis B virus (HBV) surface antigen in transgenic mice expressing HBV. Antiviral research. 2011; 90(3); 227-230. [PubMed: 21545812].

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