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NZ751943B2 - Hepatitis c virus immunogenic compositions and methods of use thereof - Google Patents
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NZ751943B2 - Hepatitis c virus immunogenic compositions and methods of use thereof - Google Patents

Hepatitis c virus immunogenic compositions and methods of use thereof

Info

Publication number
NZ751943B2
NZ751943B2 NZ751943A NZ75194317A NZ751943B2 NZ 751943 B2 NZ751943 B2 NZ 751943B2 NZ 751943 A NZ751943 A NZ 751943A NZ 75194317 A NZ75194317 A NZ 75194317A NZ 751943 B2 NZ751943 B2 NZ 751943B2
Authority
NZ
New Zealand
Prior art keywords
seq
hcv
polypeptide
immunogenic composition
amino acid
Prior art date
Application number
NZ751943A
Other versions
NZ751943A (en
Inventor
Chao Chen
Darren Hockman
Michael Houghton
Abdolamir Landi
John L Law
Michael Logan
Original Assignee
The Governors Of The University Of Alberta
Filing date
Publication date
Application filed by The Governors Of The University Of Alberta filed Critical The Governors Of The University Of Alberta
Priority claimed from PCT/IB2017/055714 external-priority patent/WO2018055535A2/en
Publication of NZ751943A publication Critical patent/NZ751943A/en
Publication of NZ751943B2 publication Critical patent/NZ751943B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/53—DNA (RNA) vaccination
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55544—Bacterial toxins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/70—Multivalent vaccine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/29—Hepatitis virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10041—Use of virus, viral particle or viral elements as a vector
    • C12N2710/10043—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/24011—Poxviridae
    • C12N2710/24111—Orthopoxvirus, e.g. vaccinia virus, variola
    • C12N2710/24134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/24011—Poxviridae
    • C12N2710/24111—Orthopoxvirus, e.g. vaccinia virus, variola
    • C12N2710/24141—Use of virus, viral particle or viral elements as a vector
    • C12N2710/24143—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/24011—Flaviviridae
    • C12N2770/24211—Hepacivirus, e.g. hepatitis C virus, hepatitis G virus
    • C12N2770/24234—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Abstract

The present disclosure provides an immunogenic composition comprising: a) a hepatitis C virus (HCV) heterodimeric polypeptide that includes HCV E1 and E2 polypeptides; b) a T-cell epitope polypeptide comprising a T-cell epitope present in an HCV protein other than E1 and E2; and c) a pharmaceutically acceptable excipient. The present disclosure provides a method of inducing an immune response, in an individual, to an HCV polypeptide. The present disclosure provides an immunogenic composition comprising: a) a polypeptide that comprises one or more T-cell epitopes present in an HCV protein other than E1 and E2; and b) a pharmaceutically acceptable excipient.

Claims (24)

What is claimed is:
1. An immunogenic composition comprising: a) a hepatitis C virus (HCV) E1/E2 heterodimeric polypeptide comprising: i) a full-length HCV E1 polypeptide; and ii) a full-length HCV E2 polypeptide; b) a T-cell epitope polypeptide comprising a T-cell epitope present in an HCV protein other than E1 and E2, wherein the T-cell epitope polypeptide comprises an amino acid sequence having at least 90% amino acid sequence identity to the amino acid sequence of any one of TP29 (SEQ ID NO:94), TP50 (SEQ ID NO:99), TP52 (SEQ ID NO:95), TP70 (SEQ ID NO:96), TP100 (SEQ ID NO:97), TP171 (SEQ ID NO:89), TP228 (SEQ ID NO:81), TP553 (SEQ ID NO:100), TP778 (SEQ ID NO:101), and TP1985 (SEQ ID NO:102); and c) a pharmaceutically acceptable carrier, wherein the HCV E1/E2 heterodimer and the T-cell epitope polypeptide are separate entities.
2. The immunogenic composition of claim 1, wherein the T-cell epitope polypeptide comprises an amino acid sequence having at least 95% amino acid sequence identity to the amino acid sequence of or comprising the amino acid sequence of any one of TP29 (SEQ ID NO:94), TP50 (SEQ ID NO:99), TP52 (SEQ ID NO:95), TP70 (SEQ ID NO:96), TP100 (SEQ ID NO:97), TP171 (SEQ ID NO:89), TP228 (SEQ ID NO:81), TP553 (SEQ ID NO:100), TP778 (SEQ ID NO:101), and TP1985 (SEQ ID NO:102).
3. The immunogenic composition of claim 1, wherein the T-cell epitope polypeptide comprises the amino acid sequence of any one of TP29 (SEQ ID NO:94), TP50 (SEQ ID NO:99), TP52 (SEQ ID NO:95), TP70 (SEQ ID NO:96), TP100 (SEQ ID NO:97), TP171 (SEQ ID NO:89), TP228 (SEQ ID NO:81), TP553 (SEQ ID NO:100), TP778 (SEQ ID NO:101), and TP1985 (SEQ ID NO:102).
4. The immunogenic composition of any one of claims 1-3, wherein: a) the HCV E2 polypeptide is derived from an HCV of major genotype 1, 2, 3, 4, 5, 6, or 7; and b) the HCV E1 polypeptide is derived from an HCV of major genotype 1, 2, 3, 4, 5, 6, or MARKED-UP COPY
5. The immunogenic composition of any one of claims 1-4, wherein the HCV E2 polypeptide and the HCV E1 polypeptide are derived from an HCV of the same genotype.
6. The immunogenic composition of any one of claims 1-4, wherein the HCV E2 polypeptide and the HCV E1 polypeptide are derived from an HCV of different genotypes.
7. The immunogenic composition of any one of claims 1-6, wherein the composition further comprises a polypeptide comprising one or more T cell epitopes present in one or more of: a) cholera toxin or toxoid; b) tetanus toxin or toxoid; c) diphtheria toxin or toxoid; and d) CRM197.
8. The immunogenic composition of any one of claims 1-7, wherein the HCV E2 polypeptide comprises Gly-Pro, Gly-Ser, Gly, or Ser appended to the N-terminus of an HCV E2 polypeptide.
9. 9 An immunogenic composition comprising: a) one or more nucleic acids comprising nucleotide sequences encoding: i) a hepatitis C virus (HCV) E1/E2 heterodimer comprising a full-length HCV E1 polypeptide; and a full-length HCV E2 polypeptide; and ii) a T-cell epitope polypeptide comprising a T-cell epitope present in an HCV protein other than E1 and E2, wherein the T-cell epitope polypeptide comprises an amino acid sequence having at least 90% amino acid sequence identity to the amino acid sequence of any one of TP29 (SEQ ID NO:94), TP50 (SEQ ID NO:99), TP52 (SEQ ID NO:95), TP70 (SEQ ID NO:96), TP100 (SEQ ID NO:97), TP171 (SEQ ID NO:89), TP228 (SEQ ID NO:81), TP553 (SEQ ID NO:100), TP778 (SEQ ID NO:101), and TP1985 (SEQ ID NO:102); and b) a pharmaceutically acceptable carrier, wherein the HCV E1/E2 heterodimer and the T-cell epitope polypeptide are separate entities.
10. The immunogenic composition of claim 9, wherein the T-cell epitope polypeptide comprises an amino acid sequence having at least 95% amino acid sequence identity to the amino acid sequence of or comprising the amino acid sequence of one of TP29 (SEQ ID NO:94), TP50 (SEQ ID NO:99), TP52 (SEQ ID NO:95), TP70 (SEQ ID NO:96), TP100 (SEQ ID NO:97), MARKED-UP COPY TP171 (SEQ ID NO:89), TP228 (SEQ ID NO:81), TP553 (SEQ ID NO:100), TP778 (SEQ ID NO:101), and TP1985 (SEQ ID NO:102).
11. The immunogenic composition of claim 9, wherein the T-cell epitope polypeptide comprises the amino acid sequence of one of TP29 (SEQ ID NO:94), TP50 (SEQ ID NO:99), TP52 (SEQ ID NO:95), TP70 (SEQ ID NO:96), TP100 (SEQ ID NO:97), TP171 (SEQ ID NO:89), TP228 (SEQ ID NO:81), TP553 (SEQ ID NO:100), TP778 (SEQ ID NO:101), and TP1985 (SEQ ID NO:102).
12. The immunogenic composition of any one of claims 9-11, wherein the HCV E2 polypeptide and the HCV E1 polypeptide are derived from an HCV of the same genotype.
13. The immunogenic composition of any one of claims 9-11, wherein the HCV E2 polypeptide and the HCV E1 polypeptide are derived from an HCV of different genotypes.
14. The immunogenic composition of any one of claims 9-13, wherein the HCV E2 polypeptide comprises Gly-Pro, Gly-Ser, Gly, or Ser appended to the N-terminus of an HCV E2 polypeptide
15. The immunogenic composition of any one of claims 9-14, wherein the one or more nucleic acids are present in recombinant expression vectors.
16. The immunogenic composition of any one of claims 9-14, wherein the one or more recombinant expression vectors are recombinant viral vectors.
17. The immunogenic composition of claim 16, wherein said recombinant viral vector is a recombinant modified vaccinia Ankara vector.
18. The immunogenic composition of claim 16, wherein said recombinant viral vector is a recombinant replication-defective adenovirus.
19. The immunogenic composition of any one of claims 16-18, wherein the one or more recombinant viral vectors are packaged into viral particles.
20. The immunogenic composition of any one of claims 9-14, wherein the one or more nucleic acids are DNA. MARKED-UP COPY
21. The immunogenic composition of any one of claims 9-14, wherein the one or more nucleic acids are RNA.
22. The immunogenic composition of any one of claims 1-21, comprising an adjuvant.
23. The immunogenic composition of claim 22, wherein the adjuvant comprises MF59; alum; poly(DL-lactide co-glycolide); a CpG oligonucleotide; keyhole limpet hemocyanin; saponin; monophosphoryl lipid A (MPL); 3-Q-desacyl- 4'-monophosphoryl lipid A (3DMPL); a suspension of liposomes comprising MPL or 3DMPL; an oil-in-water emulsion; an oil-in-water emulsion comprising a muramyl peptide or a bacterial cell wall component; a suspension of liposomes comprising MPL or 3DMPL and Quillaja saponaria 21 (QS21); AS01; AS03; AS04; AS15; or a mixture of alum and MPL.
24. Use of an effective amount of the immunogenic composition of any one of claims 1-23 in the manufacture of a medicament to induce an immune response to a hepatitis C virus (HCV) in an individual.
NZ751943A 2017-09-21 Hepatitis c virus immunogenic compositions and methods of use thereof NZ751943B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662397763P 2016-09-21 2016-09-21
PCT/IB2017/055714 WO2018055535A2 (en) 2016-09-21 2017-09-21 Hepatitis c virus immunogenic compositions and methods of use thereof

Publications (2)

Publication Number Publication Date
NZ751943A NZ751943A (en) 2025-08-29
NZ751943B2 true NZ751943B2 (en) 2025-12-02

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