Therapeutic vaccine for Hepatitis b virus (HBV) using the HBV PreS1 and/or PreS2, and/or s-HBsAg regions of the HBV envelope protein
Compositions including a CD180 binding ligand and a linked Hepatitis B antigen and their use are disclosed. The Hepatitis B antigen includes Hepatitis B virus pre-S1 and/or pre-S2 region of the HBV envelope protein (HBVpreS1/S2Ag), L-HBsAg, MHBsAg, S-HBsAg, or antigenic fragments or mutants thereof.
1. A polypeptide, comprising an amino acid sequence having at least 90% identity to the amino acid sequence of SEQ ID NO:67 residues 21-697.
2. The polypeptide of claim 1 , comprising an amino acid sequence having at least 95% identity to the amino acid sequence of SEQ ID NO:67 residues 21-697.
3. The polypeptide of claim 1 , comprising an amino acid sequence having at least 98% identity to the amino acid sequence of SEQ ID NO:67 residues 21-697.
4. The polypeptide of claim 1 , comprising the amino acid sequence of SEQ ID NO:67 residues 21-697.
5. The polypeptide of claim 1 comprising an amino acid sequence having at least 90% identity to the amino acid sequence of SEQ ID NO:67.
6. The polypeptide of claim 1 , comprising an amino acid sequence having at least 95% identity to the amino acid sequence of SEQ ID NO:67.
7. The polypeptide of claim 1 , comprising an amino acid sequence having at least 98% identity to the amino acid sequence of SEQ ID NO:67.
8. The polypeptide of claim 1 , comprising the amino acid sequence of SEQ ID NO:67.
9. An isolated nucleic acid encoding the polypeptide of claim 1 .
10. An expression vector comprising the isolated nucleic acid of claim 9 operatively linked to a suitable control sequence.
11. A recombinant host cell comprising the expression vector of claim 10 .
12. A pharmaceutical composition, comprising
(a) the polypeptide claim 1 ; and
(b) a pharmaceutically acceptable carrier.
13. A method for treating or limiting the development of a hepatitis-B virus (HBV)-related disorder, comprising administering to an individual in need thereof an amount effective to treat or limit development of the HBV-related disorder of the polypeptide of claim 1 , or pharmaceutically acceptable salts thereof.
14. An isolated nucleic acid encoding the polypeptide of claim 4 .
15. An isolated nucleic acid encoding the polypeptide of claim 8 .
16. An isolated nucleic acid encoding the polypeptide of claim 14 , wherein the nucleic acid comprises the nucleotide sequence of SEQ ID NO:68.
17. An expression vector comprising the isolated nucleic acid of claim 14 operatively linked to a suitable control sequence.
18. An expression vector comprising the isolated nucleic acid of claim 15 operatively linked to a suitable control sequence.
19. An expression vector comprising the isolated nucleic acid of claim 16 operatively linked to a suitable control sequence.
20. A recombinant host cell comprising the expression vector of claim 17 .
21. A recombinant host cell comprising the expression vector of claim 18 .
22. A recombinant host cell comprising the expression vector of claim 19 .
23. A method for treating or limiting the development of a hepatitis-B virus (HBV)-related disorder, comprising administering to an individual in need thereof an amount effective to treat or limit development of the HBV-related disorder of the polypeptide of claim 4 , or pharmaceutically acceptable salts thereof.
24. A method for treating or limiting the development of a hepatitis-B virus (HBV)-related disorder, comprising administering to an individual in need thereof an amount effective to treat or limit development of the HBV-related disorder of the polypeptide of claim 8 , or pharmaceutically acceptable salts thereof.