Immunogenic compositions for treatment of Hepatitis B
The present disclosure provides compositions and methods useful for inducing a The cell response in a subject suffering from Hepatitis B. As described herein, the compositions of the disclosure comprise HBsAg having S, Pre-S1 and Pre-S2 proteins and an aluminum phosphate adjuvant. In a preferred embodiment, the immunogenic composition comprises at least 20 μg/ml of HBsAg antigen and the amount of non-adsorbed antigen is at least 30%.
1. An immunogenic composition comprising:
(a) an HBsAg antigen comprising S protein, Pre-S1 protein and Pre-S2 protein; and
(b) an aluminum phosphate adjuvant,
wherein the composition comprises at least 20 μg/ml of HBsAg antigen and the amount of non-adsorbed antigen is at least 30%.
2. The immunogenic composition of claim 1 wherein the aluminum is present in a concentration of 500 μg/ml.
3. The immunogenic composition of claim 1 wherein the HBsAg antigen is present in a concentration of 20 μg/ml.
4. The immunogenic composition of claim 1 wherein the HBsAg antigen is present in a concentration of 40 μg/ml.
5. The immunogenic composition of claim 1 wherein the HBsAg antigen is present in a concentration of 60 μg/ml.
6. The immunogenic composition of claim 1 for use inducing a Th1 cell response in a mammal.
7. Use of the immunogenic composition of claim 1 for manufacture of a drug for inducing a Th1 cell response in a subject.
8. The use of claim 7 wherein the subject has been infected with Hepatitis B.
9. A pharmaceutical composition comprising the immunogenic composition of claim 1 and a pharmaceutically acceptable excipient.
10. The pharmaceutical composition of claim 9 for use in treating a subject suffering from Hepatitis B.
11. A method of inducing a Th1 cell response in a mammal, said method comprising administering the immunogenic composition of claim 1 .
12. A method of treating Hepatitis B in a subject, said method comprising administering a therapeutically effective amount of the immunogenic composition of claim 1 to the subject.
13. The method of claim 12 wherein an additional Hepatitis B treatment is administered to the subject prior to, concurrently with, or after administration of the immunogenic composition to the subject.
14. The method of claim 13 wherein the additional Hepatitis B treatment is a nucleoside inhibitor or a pegylated interferon alpha.
15. The method of claim 13 wherein the additional Hepatitis B treatment is a polymerase inhibitor, an RNase H inhibitor, a TLR agonist, an N-glycosylation inhibitor, an antisense oligonucleotide, an anti-hepatitis B antibody, a capsid inhibitor, a core protein inhibitor, a core assembly modulator, an S-antigen reducer or sequesterer, a nucleic acid polymers, a ccc DNA inhibitor, an interferon, an immune modulator or an siRNA.