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NZ743654B2 - Means and methods for treating hbv - Google Patents
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NZ743654B2 - Means and methods for treating hbv - Google Patents

Means and methods for treating hbv

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Publication number
NZ743654B2
NZ743654B2 NZ743654A NZ74365417A NZ743654B2 NZ 743654 B2 NZ743654 B2 NZ 743654B2 NZ 743654 A NZ743654 A NZ 743654A NZ 74365417 A NZ74365417 A NZ 74365417A NZ 743654 B2 NZ743654 B2 NZ 743654B2
Authority
NZ
New Zealand
Prior art keywords
virus
hepatitis
protein
vector
antigen
Prior art date
Application number
NZ743654A
Other versions
NZ743654A (en
Inventor
Tanja Bauer
Anna Kosinska
Haeusl Martin Mueck
Ulrike Protzer
Original Assignee
Helmholtz Zentrum München Deutsches Forschungszentrum Für Gesundheit Und Umwelt (Gmbh)
Filing date
Publication date
Application filed by Helmholtz Zentrum München Deutsches Forschungszentrum Für Gesundheit Und Umwelt (Gmbh) filed Critical Helmholtz Zentrum München Deutsches Forschungszentrum Für Gesundheit Und Umwelt (Gmbh)
Priority claimed from PCT/EP2017/050553 external-priority patent/WO2017121791A1/en
Publication of NZ743654A publication Critical patent/NZ743654A/en
Publication of NZ743654B2 publication Critical patent/NZ743654B2/en

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    • 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
    • A61K2039/515—Animal cells
    • A61K2039/5156—Animal cells expressing foreign proteins
    • 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
    • A61K2039/52—Bacterial cells; Fungal cells; Protozoal cells
    • 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
    • A61K2039/525—Virus
    • 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
    • A61K2039/525—Virus
    • A61K2039/5256—Virus expressing foreign proteins
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • A61K2039/55505—Inorganic adjuvants
    • 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
    • A61K2039/55555—Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • 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
    • A61K2039/55561—CpG containing adjuvants; Oligonucleotide containing adjuvants
    • 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
    • A61K2039/58—Medicinal preparations containing antigens or antibodies raising an immune response against a target which is not the antigen used for immunisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • A61K39/292—Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/30—Cellular immunotherapy characterised by the recombinant expression of specific molecules in the cells of the immune system
    • A61K40/34—Antigenic peptides
    • 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
    • A61P31/20—Antivirals for DNA 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
    • C12N15/1131—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing against 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86—Viral vectors
    • 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
    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/10—Type of nucleic acid
    • C12N2310/14—Type of nucleic acid interfering nucleic acids [NA]
    • 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
    • C12N2320/00—Applications; Uses
    • C12N2320/30—Special therapeutic applications
    • C12N2320/31—Combination therapy
    • 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
    • C12N2730/00—Reverse transcribing DNA viruses
    • C12N2730/00011—Details
    • C12N2730/10011—Hepadnaviridae
    • C12N2730/10111—Orthohepadnavirus, e.g. hepatitis B virus
    • C12N2730/10134—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
    • C12N2799/00—Uses of viruses
    • C12N2799/02—Uses of viruses as vector
    • C12N2799/021—Uses of viruses as vector for the expression of a heterologous nucleic acid
    • C12N2799/023—Uses of viruses as vector for the expression of a heterologous nucleic acid where the vector is derived from a poxvirus
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention relates to an improved recombinant vaccination vector for the treatment or vaccination against hepatitis B virus (HBV) as well as pharmaceutical compositions or vaccines comprising said recombinant vaccination vector. The present invention also relates to a recombinant vaccination vector for use in a method of vaccination against HBV, as well as kits comprising a vaccine comprising the recombinant vaccination vector. In a particular embodiment, the recombinant vaccination vector comprises: (a) an envelope protein (HBs-antigen) from hepatitis B virus serotype adw, (b) a core protein (HBc-antigen) from hepatitis B virus serotype ayw, (c) an immunogenic envelope protein (HBs-antigen) from hepatitis B virus, (d) an immunogenic core protein (HBc-antigen) from hepatitis B virus, and (e) an immunogenic reverse transcriptase (RT) domain of a polymerase from hepatitis B virus.

Claims (37)

1. A recombinant vaccination vector sing (a) an envelope n (HBs-antigen) from hepatitis B virus serotype adw, wherein the envelope protein is preferably a small or large envelope protein from hepatitis B virus genotype A serotype adw, wherein the small or large envelope protein is ably a small pe protein; (b) a core protein (HBc-antigen) from hepatitis B virus serotype ayw, wherein the core protein is preferably from tis B virus genotype D serotype ayw; (c) an immunogenic envelope n (HBs-antigen) from hepatitis B virus having at least 90% ce identity to the amino acid sequence set forth in SEQ ID NO: (d) an immunogenic core protein ntigen) from hepatitis B virus having at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: 2; (e) an immunogenic reverse transcriptase (RT) domain of a polymerase from tis B virus having at least 96 % sequence identity to the amino acid sequence set forth in SEQ ID NO: 3.
2. The recombinant vaccination vector of claim 1, wherein the HBs-antigen in (c) and/or the HBc-antigen in (d) is/are from hepatitis B virus genotype C.
3. The recombinant vaccination vector of claim 1 or 2, wherein the immunogenic HBsantigen in (c) has at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: 4 and/or the immunogenic RT domain of a polymerase in (e) has at least 90% sequence ty to the amino acid sequence set forth in SEQ ID NO: 6.
4. The recombinant vaccination vector of any one of the preceding claims, wherein the core protein from hepatitis B virus serotype ayw in (b) is a C-terminally truncated core protein comprising or consisting of amino acids 1-149 of the HBc-antigen from hepatitis B virus genotype D serotype ayw.
5. The recombinant vaccination vector of any one of the preceding claims, further expressing (f) a CD70.
6. The recombinant vaccination vector of claim 5, wherein the CD70 is a human CD70.
7. The recombinant vaccination vector of claim 5 or 6, wherein the CD70 has at least 90% sequence identity to the amino acid ce set forth in SEQ ID NO: 26.
8. The recombinant vaccination vector of any one of the preceding claims, wherein the recombinant vaccination vector is a virus, a virus like particle or a bacterium.
9. The recombinant vaccination vector of any one of the preceding claims, wherein the recombinant vaccination vector is a Modified Vaccinia Ankara (MVA) virus.
10. The recombinant ation vector of any one of claims 1 to 6, wherein the recombinant vector is an attenuated Salmonella strain, a Cytomegalovirus (CMV)- based vector, a vesicular stomatitis virus (VSV)-based vector, an Adenoviral vector or a Measles vector.
11. The recombinant ation vector of claim 9, wherein at least one, preferably at least two, preferably at least three, preferably at least four, preferably five nucleic acid ce(s) encoding for (a), (b), (c), (d), and/or (e) is/are comprised in one expression te.
12. The recombinant vaccination vector of claim 9 or 11, wherein at least one of the nucleic acids encoding for (a), (b), (c), (d), and/or (e) is/are under control of a poxviral promoter, n the poxviral promoter is ably P7.5 or PH5.
13. The recombinant vaccination vector of claim 11 or 12, wherein the expression cassette encodes for an amino acid ce set forth in SEQ ID NO: 7.
14. The recombinant vaccination vector of any one claims 9 and 11 to 13, wherein a nucleic acid sequence encoding at least one of (a), (b), (c), (d), and/or (e) is inserted into deletion I (del I), deletion II (del II), deletion III (del III), deletion IV (del IV), deletion V (del V), or deletion VI (del VI), preferably deletion III (del III) of the MVA genome.
15. Use of the recombinant vaccination vector according to any one of claims 9 and 11 to 14 in the preparation of a medicament for the treatment of a disease in a subject.
16. The use of claim 15, wherein the medicament is a vaccine.
17. The use according to claim 15 or 16 wherein the medicament is for vaccination against hepatitis B, and wherein the medicament comprises (a’) an envelope protein from tis B virus serotype adw, wherein the pe protein is preferably a small or large envelope protein from hepatitis B virus genotype A serotype adw, wherein the small or large envelope n is preferably a small pe protein; and/or (b’) a core protein (HBc-antigen) from hepatitis B virus serotype ayw, wherein the core protein is preferably from hepatitis B virus genotype D serotype ayw; and the medicament is formulated to be administered to the subject.
18. The use according to any one of claims 15 to 17, wherein the medicament is for therapeutic vaccination.
19. The use according to claim 17 or 18, wherein the medicament is formulated to be administered in (i) a priming step and (ii) a boosting step.
20. The use according to any one of claims 17 to 19, wherein the envelope protein and/or the core protein is formulated to be co-administered with at least one adjuvant, wherein the adjuvant is preferably selected from the group consisting of poly[di(sodium carboxylatoethylphenoxy)]phosphazene (PCEP), an immune atory oligonucleotide, a toll like receptor (TLR) agonist, a saponin or combinations thereof, wherein the TLR agonist is preferably a TLR 3 t, a TLR 4 agonist, a TLR 7 agonist, a TLR 8 agonist, or a TLR 9 agonist, and wherein the immune atory oligonucleotide is preferably polyinosinic-polycytidylic acid (poly I/C), CpG, a retinoic acid-inducible gene I ) ligand, a Stimulatory of eron genes (STING) ligand, cyclic di-AMP, cyclic di-CMP, cyclic di-GMP, a TLR 7 agonist, a TLR 8 agonist, a toxin A1 subunit (CTA1)-DD, or double mutant heat-labile toxin (dmLT).
21. The use ing to claim 20, wherein the adjuvant is PCEP and/or a CpG adjuvant.
22. The use according to claim 20, wherein the nt is cyclic di-AMP.
23. The use according to claim 19 and any one of claims 20 to 22 according to claim 19, wherein (i) is conducted at least about 1 day before conducting (ii), preferably at least about 5 days, preferably at least about 1 week, preferably about 1 week to about 8 weeks, preferably about 2 weeks to about 5 weeks, preferably about 3 weeks to about 4 weeks.
24. The use according to claim 19 and any one of claims 20 to 23 according to claim 19, further comprising after (i) and prior to (ii): (i’) a pharmaceutical composition formulated to be stered to the subject, the pharmaceutical composition comprising: (a’) an envelope protein from hepatitis B virus genotype A, n the envelope n is preferably a small or large pe protein from hepatitis B virus genotype A serotype adw, wherein the small or large envelope protein is preferably a small envelope n; and/or (b’) a core protein (HBc-antigen) from tis B virus genotype D, wherein the core protein is preferably from hepatitis B virus genotype D serotype ayw, wherein (i’) is ably a boosting step.
25. The use of claim 24, wherein (i) is conducted at least about 1 day before conducting (i’), ably at least about 5 days, preferably at least about 1 week, preferably about 1 week to about 8 weeks, preferably about 2 weeks to about 5 weeks, preferably about 3 weeks to about 4 weeks, and wherein (i’) is conducted at least about 1 day before conducting (ii), preferably at least about 5 days, preferably at least about 1 week, preferably about 1 week to about 8 weeks, preferably about 2 weeks to about 5 weeks, preferably about 3 weeks to about 4 weeks.
26. The use of any one of claims 15 to 25, wherein administration is to be by a parenteral or mucosal route.
27. The use of claim 25, wherein administration is to be intramuscular, and wherein step (i) and/or (i’) comprises an adjuvant, wherein the adjuvant comprises cyclic di-AMP.
28. The use of claim 25, wherein administration is to be subcutaneous or intramuscular, and wherein step (i) and/or (i’) comprises an adjuvant, wherein the adjuvant comprises poly I/C or RIG-I-ligand.
29. A vaccine or a ceutical composition comprising the recombinant vaccination vector of any one of claims 1 to 14.
30. The vaccine of claim 29, wherein the recombinant vaccination vector is a MVA virus of any one of claims 9 and 11 to 14 or a Salmonella strain of claim 10.
31. The vaccine of claim 29 or 30, n the vaccine is formulated to be administered as a parenteral or l e.
32. A kit comprising: (i) a protein ition comprising: (a) an envelope protein from hepatitis B virus genotype A, wherein the envelope protein is ably a small or large envelope protein from hepatitis B virus genotype A serotype adw, wherein the small or large envelope protein is preferably a small envelope protein; and/or (b) a core n (HBc-antigen) from hepatitis B virus genotype D, wherein the core protein is preferably from hepatitis B virus genotype D serotype ayw; (ii) the vaccine of any one of claims 29 to 31.
33. The kit of claim 32, n the protein composition is formulated to be administered parenterally, n the composition preferably comprises at least one adjuvant that is PCEP and/or a CpG adjuvant.
34. The kit of claim 32, wherein the n composition is formulated to be administered mucosaly, wherein the composition preferably comprises an adjuvant selected from the group consisting of , dmLT, PCEP, poly I/C, ligand, c-di-AMP, c-di- CMP and c-diGMP or combinations thereof.
35. The kit of claim 32, wherein the protein composition is formulated to be administered intramuscularly, n the composition preferably comprises at least one adjuvant that is cyclic di-AMP.
36. The kit of claim 32, wherein the protein composition is formulated to be administered subcutaneously or intramuscularly, wherein the composition preferably comprises at least one adjuvant that is poly I/C.
37. An expression cassette comprising nucleic acids encoding: (a) an envelope protein (HBs-antigen) from hepatitis B virus serotype adw, wherein the pe protein is preferably a small or large envelope protein from hepatitis B virus genotype A serotype adw, wherein the small or large envelope protein is preferably a small envelope protein; (b) a core protein (HBc-antigen) from hepatitis B virus serotype ayw, wherein the core protein is preferably from hepatitis B virus genotype D serotype ayw; (c) an immunogenic envelope protein (HBs-antigen) from hepatitis B virus having at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: (d) an immunogenic core protein (HBc-antigen) from hepatitis B virus having at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: 2; (e) an immunogenic RT domain of a polymerase from tis B virus having at least 96 % sequence ty to the amino acid sequence set forth in SEQ ID NO: 3.
NZ743654A 2017-01-12 Means and methods for treating hbv NZ743654B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
LU92942 2016-01-12
PCT/EP2017/050553 WO2017121791A1 (en) 2016-01-12 2017-01-12 Means and methods for treating hbv

Publications (2)

Publication Number Publication Date
NZ743654A NZ743654A (en) 2025-06-27
NZ743654B2 true NZ743654B2 (en) 2025-09-30

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