JPWO2021154752A5 - - Google Patents

Claims (21)

(a) a nucleic acid comprising at least one nucleic acid sequence encoding a hepatitis D antigen (HDAg) and at least one nucleic acid sequence encoding PreS1; and (b) at least one HDAg polypeptide sequence and at least one An immunogenic composition comprising a polypeptide comprising a PreS1 polypeptide sequence. The composition of claim 1, wherein the at least one nucleic acid sequence encoding the HDAg comprises the sequence shown in SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, or SEQ ID NO: 4, or any combination thereof. . 3. The composition of claim 1 or 2, wherein the at least one nucleic acid sequence encoding PreS1 comprises the sequence shown in SEQ ID NO: 9 or SEQ ID NO: 10, or both. The nucleic acid according to claims 1 to 3, wherein each HDAg nucleic acid sequence is grouped with a PreS1 nucleic acid sequence, and in each group, the PreS1 nucleic acid sequence is located immediately downstream of the HDAg nucleic acid sequence. The composition according to any one of the items. further comprising at least one nucleic acid sequence encoding an autocatalytic peptide cleavage site, said HDAg nucleic acid sequence and said PreS1 nucleic acid sequence being separated by at least one nucleic acid sequence encoding said autocatalytic peptide cleavage site; The composition according to claim 4. The at least one nucleic acid sequence encoding the autocatalytic peptide cleavage site is a nucleic acid sequence of Porcine Teschovirus type 1-derived 2A (P2A), a foot-and-mouth disease virus-derived 2A (F2A) nucleic acid sequence, or an equine rhinitis A virus (ERAV). The autocatalytic peptide cleavage site is encoded by a GSG at its N-terminus, and comprises a nucleic acid sequence selected from the group consisting of the nucleic acid sequence of the derived virus 2A (E2A) and the nucleic acid sequence of the Thesea asigna virus 2A (T2A), 6. The composition according to claim 5, optionally comprising a (glycine-serine-glycine) motif. 7. The composition of claim 5 or 6, wherein the at least one nucleic acid sequence encoding the autocatalytic peptide cleavage site comprises the sequence shown in SEQ ID NO: 13. A composition according to any one of claims 1 to 7, wherein the nucleic acid is codon-optimized for human expression. The composition according to any one of claims 1 to 8, wherein the nucleic acid comprises a sequence having at least 95% sequence identity with any one of the sequences set forth in SEQ ID NOs: 15-24, 35, or 36. thing. 10. The composition of claim 9, wherein the nucleic acid comprises a sequence having at least 95% sequence identity with any one of the sequences set forth in SEQ ID NO: 18, SEQ ID NO: 35, or SEQ ID NO: 36. Claims 1 to 10, wherein the at least one HDAg polypeptide sequence comprises any one of the sequences shown in SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, or SEQ ID NO: 8, or any combination thereof. The composition according to any one of the above. 12. The composition of any one of claims 1 to 11, wherein the at least one PreS1 polypeptide sequence comprises the sequence shown in SEQ ID NO: 11 or SEQ ID NO: 12, or both. 13. The composition of any one of claims 1-12, wherein said at least one PreS1 polypeptide sequence is located downstream of said at least one HDAg polypeptide sequence. 14. The composition of any one of claims 1-13, wherein the polypeptide comprises a sequence having at least 95% sequence identity with any one of the sequences set forth in SEQ ID NOs: 25-34 or 37. 15. The polypeptide according to any one of claims 1 to 14, wherein the polypeptide comprises a sequence having at least 95% sequence identity with any one of the sequences set forth in SEQ ID NO: 29, 31, 32, or 37. Composition. A composition according to any one of claims 1 to 15, wherein the polypeptide is recombinantly expressed. 17. The composition of claim 16, wherein the polypeptide is recombinantly expressed in a mammalian, bacterial, yeast, insect, or cell-free system. Composition according to any one of claims 1 to 17, further comprising an adjuvant. The composition according to any one of claims 1 to 18, wherein the nucleic acid comprises DNA. Composition according to any one of claims 1 to 19, wherein the nucleic acid is provided in the form of a recombinant vector. A composition according to any one of claims 1 to 20 for use in the treatment or inhibition of hepatitis B or hepatitis D.