HBV vaccines and methods treating HBV
AssigneeGilead Sciences, Inc.
InventorsScott J. Balsitis, Sarah M. Ahmadi-Erber, Timo Schippers, Sarah Schmidt
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Abstract
Provided are HBV immunogenic polypeptides, polynucleotides encoding such polypeptides, vectors expressing such immunogenic polypeptides for use in eliciting an immune response against HBV; pharmaceutical and immunogenic compositions and kits comprising such polypeptides, polynucleotides or vectors, and methods of use in treating and/or preventing HBV.
Claims53
A polynucleotide encoding a truncated hepatitis B virus (HBV) polymerase polypeptide, the polypeptide comprising an inactivated reverse transcriptase domain and an inactivated RNase H, wherein the polypeptide is no longer than 600 amino acids in length and does not comprise all of the terminal protein (TP) domain and does not comprise all or part of the Spacer domain, wherein the polypeptide comprises or consists of the amino acid sequence of any one of SEQ ID NOs:
- 13-14.
A polynucleotide encoding a fusion protein comprising or consisting of the amino acid sequence of SEQ ID NO:
- 41, or the amino acid sequence that is at least 94%, 95%, 96%, 97%, 98% or 99% identical to the full length of SEQ ID NO:
- 41, the fusion protein comprising in sequential order from the N-terminus to the C-terminus, an HBV core polypeptide and an HBV small surface antigen (sAg) polypeptide, wherein the fusion protein is no longer than 450 amino acids in length, does not comprise an HBV pre-S1 polypeptide and/or an HBV pre-S2 polypeptide, and wherein the core polypeptide is from an HBV genotype D and the sAg polypeptide is from an HBV genotype D, wherein the polynucleotide comprises or consists of the nucleic acid sequence of SEQ ID NO:
- 37, or the nucleic acid sequence that is at least 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% identical to the full length of SEQ ID NO:
- 37.
A truncated hepatitis B virus (HBV) polymerase polypeptide comprising an inactivated reverse transcriptase domain and an inactivated RNase H, wherein the polypeptide is no longer than 600 amino acids in length and does not comprise all of the terminal protein (TP) domain and does not comprise all or part of the Spacer domain, wherein the polypeptide comprises or consists of the amino acid sequence of any one of SEQ ID NOs:
- 13-14.
A fusion protein comprising in sequential order from the N-terminus to the C-terminus, an HBV core polypeptide and an HBV small surface antigen (sAg) polypeptide, wherein the fusion protein is no longer than 450 amino acids in length, does not comprise an HBV pre-S1 polypeptide and/or an HBV pre-S2 polypeptide, and wherein:
- the core polypeptide is from an HBV genotype D and the sAg polypeptide is from an HBV genotype D, wherein the fusion protein comprises or consists of the amino acid sequence of any one of SEQ ID NOs:
- 40-41, or the amino acid sequence that is at least 97%, 98% or 99% identical to the full length of any one of SEQ ID NOs:
- 40-41.
An arenavirus vector comprising a polynucleotide encoding an HBV core-sAg fusion polypeptide comprising or consisting of the amino acid sequence of any one of SEQ ID NOs:
- 40-41, or the amino acid sequence that is at least 97%, 98% or 99% identical to the full length of any one of SEQ ID NOs:
- 40-41, and wherein the sAg polypeptide is no longer than 450 amino acids in length and does not comprise an HBV pre-S1 polypeptide and/or an HBV pre-S2 polypeptide.
An arenavirus vector comprising a polynucleotide encoding an HBV core-sAg fusion polypeptide comprising or consisting of the amino acid sequence of any one of SEQ ID NO:
- 41, or the amino acid sequence that is at least 94%, 95%, 96%, 97%, 98% or 99% identical to the full length of any one of SEQ ID NOs:
- 41, and wherein the sAg polypeptide does not comprise an HBV pre-S1 polypeptide and/or an HBV pre-S2 polypeptide.
An arenavirus vector comprising a polynucleotide encoding a truncated HBV polymerase comprising or consisting of the amino acid sequence of any one of SEQ ID NOs:
- 13-14, and wherein the truncated HBV polymerase is no longer than 600 amino acids in length and does not comprise all of an HBV polymerase terminal protein (TP) domain and does not comprise all or part of an HBV polymerase Spacer domain.
An immunogenic composition comprising a first viral expression vector and a second viral expression vector, wherein:
- the first viral expression vector comprises a polynucleotide encoding a truncated HBV polymerase polypeptide mutant, wherein the polypeptide is no longer than 600 amino acids in length, does not comprise all of the terminal protein (TP) domain and does not comprise all or part of the Spacer domain, wherein the polypeptide comprises or consists of the amino acid sequence of any one of SEQ ID NOs:
- 13-14;
- and the second viral expression vector comprises a polynucleotide encoding a core-sAg fusion protein comprising in sequential order from the N-terminus to the C terminus, an HBV core polypeptide and an HBV small surface antigen (sAg) polypeptide, wherein the fusion protein is no longer than 450 amino acids in length, and wherein the core polypeptide is from an HBV genotype D and the sAg polypeptide is from an HBV genotype D, wherein the fusion protein comprises or consists of the amino acid sequence of any one of SEQ ID NOs:
- 40-41, or the amino acid sequence that is at least 97%, 98% or 99% identical to the full length of any one of SEQ ID NOs:
- 40-41.
Dependencies are inferred from the claim text.