Method of treating HIV-1 infection utilizing a multiepitope T cell immunogen comprising Gag, Pol, Vif, and Nef epitopes

1. An immunogenic fusion polypeptide comprising or consisting of two or more of the amino acid sequences of SEQ ID NOs: 1-16.

2. The immunogenic fusion polypeptide of claim 1 , wherein the two or more amino acid sequences comprise or consist of: each of the amino acid sequences of SEQ ID NOs: 2-10, 12, and 13.

3. The immunogenic fusion polypeptide of claim 1 , wherein the two or more amino acid sequences comprise or consist of: each of the amino acid sequences of SEQ ID NOs: 2-10 and 13.

4. The immunogenic fusion polypeptide of claim 1 , wherein the two or more amino acid sequences comprise or consist of: each of the amino acid sequences of SEQ ID NOs: 2, 3, 5-10 and 13.

5. The immunogenic fusion polypeptide of claim 1 , wherein the two or more amino acid sequences comprise or consist of: each of the amino acid sequences of SEQ ID NOs: 2-8, 10, 12, and 13.

6. The immunogenic fusion polypeptide of any one of claims 1 - 5 , wherein at least two of the two or more amino acid sequences are separated by an amino acid linker.

7. The immunogenic fusion polypeptide of claim 1 - 5 , wherein each of the two or more amino acid sequences are separated by an amino acid linker.

8. The immunogenic fusion polypeptide of claim 6 or 7 , wherein the amino acid linker is 2-20 amino acids in length.

9. The immunogenic fusion polypeptide of claim 6 or 7 , wherein the amino acid linker is 20 or more amino acids in length.

10. The immunogenic fusion polypeptide of claim 6 or 7 , wherein the amino acid linker is a single, dual, or triple alanine linker, and wherein the linker results in the formation of an AAA sequence in the junction region between adjoining sequences.

11. The immunogenic fusion polypeptide of any one of claims 1 - 10 , further comprising a signal peptide at the N-terminus.

12. The immunogenic fusion polypeptide of claim 11 , wherein the signal peptide is selected from the group consisting of: a granulocyte macrophage colony-stimulating factor (GMCSF) signal peptide, a MCP-3 chemokine signal peptide, a catenin (CATE)-derived signal peptide, and a LAMP1 signal peptide.

13. The immunogenic fusion polypeptide of claim 12 , wherein the GMCSF signal peptide comprises the amino acid sequence of SEQ ID NO: 46 or SEQ ID NO: 47.

14. An immunogenic fusion polypeptide, comprising:

i) an N-terminal signal peptide;

ii) an amino acid sequence having the amino acid sequence of SEQ ID NO: 2;

iii) an amino acid sequence having the amino acid sequence of SEQ ID NO: 3;

iv) an amino acid sequence having the amino acid sequence of SEQ ID NO: 4;

v) an amino acid sequence having the amino acid sequence of SEQ ID NO: 5;

vi) an amino acid sequence having the amino acid sequence of SEQ ID NO: 6;

vii) an amino acid sequence having the amino acid sequence of SEQ ID NO: 7;

viii) an amino acid sequence having the amino acid sequence of SEQ ID NO: 8;

ix) an amino acid sequence having the amino acid sequence of SEQ ID NO: 9;

x) an amino acid sequence having the amino acid sequence of SEQ ID NO: 10;

xi) an amino acid sequence having the amino acid sequence of SEQ ID NO: 12; and

xii) an amino acid sequence having the amino acid sequence of SEQ ID NO: 13.

15. The immunogenic fusion polypeptide of claim 14 , further comprising:

xiii) an amino acid sequence comprising at least 8 consecutive amino acids of SEQ ID NO: 11.

16. The immunogenic fusion polypeptide of claim 15 , wherein at least two of the amino acid sequences of i)-xiii) are separated by an amino acid linker.

17. The immunogenic fusion polypeptide of claim 15 , wherein each of the amino acid sequences of i)-xiii) are separated by an amino acid linker.

18. The immunogenic fusion polypeptide of claim 14 , wherein at least two of the amino acid sequences of i)-xii) are separated by an amino acid linker.

19. The immunogenic fusion polypeptide of claim 14 , wherein each of the amino acid sequences of i)-xii) are separated by an amino acid linker.

20. The immunogenic fusion polypeptide of any one of claims 16 - 19 , wherein the amino acid linker is 2-20 amino acids in length.

21. The immunogenic fusion polypeptide of any one of claims 16 - 19 , wherein the amino acid linker is 20 or more amino acids in length.

22. The immunogenic fusion polypeptide of any one of claims 16 - 19 , wherein the amino acid linker is a single, dual, or triple alanine linker, and wherein the linker results in the formation of an AAA sequence in the junction region between adjoining sequences.

23. The immunogenic fusion polypeptide of any one of claims 14 and 15 - 22 , wherein the N-terminal signal peptide is selected from the group consisting of: a granulocyte macrophage colony-stimulating factor (GMCSF) signal peptide, a MCP-3 chemokine signal peptide, a catenin (CATE)-derived signal peptide, and a LAMP1 signal peptide.

24. The immunogenic fusion polypeptide of claim 23 , wherein the GMCSF signal peptide comprises the amino acid sequence of SEQ ID NO: 46 or SEQ ID NO: 47.

25. An immunogenic fusion polypeptide, comprising:

i) an N-terminal signal peptide;

ii) an amino acid sequence having the amino acid sequence of SEQ ID NO: 2;

iii) an amino acid sequence having the amino acid sequence of SEQ ID NO: 3;

iv) an amino acid sequence having the amino acid sequence of SEQ ID NO: 4;

v) an amino acid sequence having the amino acid sequence of SEQ ID NO: 5;

vi) an amino acid sequence having the amino acid sequence of SEQ ID NO: 6;

vii) an amino acid sequence having the amino acid sequence of SEQ ID NO: 7;

viii) an amino acid sequence having the amino acid sequence of SEQ ID NO: 8;

ix) an amino acid sequence having the amino acid sequence of SEQ ID NO: 10;

x) an amino acid sequence having the amino acid sequence of SEQ ID NO: 12; and

xi) an amino acid sequence having the amino acid sequence of SEQ ID NO: 13.

26. The immunogenic fusion polypeptide of claim 25 , further comprising:

xii) an amino acid sequence comprising at least 8 amino acids of SEQ ID NO:9; and

xiii) an amino acid sequence comprising at least 8 amino acids of SEQ ID NO:11.

27. The immunogenic fusion polypeptide of claim 26 , wherein at least two of the amino acid sequences of i)-xiii) are separated by an amino acid linker.

28. The immunogenic fusion polypeptide of claim 26 , wherein each of the amino acid sequences of i)-xiii) are separated by an amino acid linker.

29. The immunogenic fusion polypeptide of claim 25 , wherein at least two of the amino acid sequences of i)-xi) are separated by an amino acid linker.

30. The immunogenic fusion polypeptide of claim 25 , wherein each of the amino acid sequences of i)-xi) are separated by an amino acid linker.

31. The immunogenic fusion polypeptide of any one of claims 27 - 30 , wherein the amino acid linker is 2-20 amino acids in length.

32. The immunogenic fusion polypeptide of any one of claims 27 - 30 , wherein the amino acid linker is 20 or more amino acids in length.

33. The immunogenic fusion polypeptide of any one of claims 27 - 30 , wherein the amino acid linker is a single, dual, or triple alanine linker, and wherein the linker results in the formation of an AAA sequence in the junction region between adjoining sequences.

34. The immunogenic fusion polypeptide of any one of claims 25 and 26 - 33 , wherein the N-terminal signal peptide is selected from the group consisting of: a granulocyte macrophage colony-stimulating factor (GMCSF) signal peptide, a MCP-3 chemokine signal peptide, a catenin (CATE)-derived signal peptide, and a LAMP1 signal peptide.

35. The immunogenic fusion polypeptide of claim 34 , wherein the GMCSF signal peptide comprises the amino acid sequence of SEQ ID NO: 46 or SEQ ID NO: 47.

36. A cell comprising the immunogenic fusion polypeptide of any one of claims 1 - 14 , 15 - 25 and 26 - 35 .

37. A vaccine comprising the immunogenic fusion polypeptide of any one of claims 1 - 14 , 15 - 25 and 26 - 35 and one or more adjuvants.

38. A kit comprising the immunogenic fusion polypeptide of any one of claims 1 - 14 , 15 - 25 and 26 - 35 , the cell of claim 36 , or the vaccine of claim 37 .

39. A method of treating or preventing a human immunodeficiency virus (HIV) infection or a disease associated with an HIV infection in a subject in need thereof, the method comprising administering to the subject the immunogenic fusion polypeptide of any one of claims 1 - 14 , 15 - 25 and 26 - 35 , wherein the immunogenic fusion polypeptide is administered in an amount effective for eliciting an immune response against HIV in the subject.

40. The method of claim 39 , wherein the subject is a human subject.

41. The method of claim 40 , wherein the immunogenic fusion polypeptide is administered to the human subject to treat acquired immune deficiency syndrome (AIDS), AIDS-related complex (ARC), or an HIV opportunistic disease.

42. The method of claim 40 , wherein the immunogenic fusion polypeptide is administered to the human subject to prevent an HIV type 1 (HIV-1), or HIV type 2 (HIV-2) infection.

43. A method of treating or preventing an HIV infection or a disease associated with an HIV infection in a subject in need thereof the method comprising sequentially administering to the subject (1) a first immunogenic fusion polypeptide of any one of claims 1 - 14 , 15 - 25 and 26 - 35 , and (2) a second immunogenic fusion polypeptide of any one of claims 1 - 14 , 15 - 25 and 26 - 35 , wherein the first immunogenic fusion polypeptide and the second immunogenic fusion polypeptide are administered in amounts effective for eliciting an immune response against HIV in the subject.

44. The method of claim 43 , wherein the subject is a human subject.

45. The method of claim 44 , wherein the immunogenic fusion polypeptide is administered to the human subject to treat acquired immune deficiency syndrome (AIDS), AIDS-related complex (ARC), or an HIV opportunistic disease.

46. The method of claim 44 , wherein the immunogenic fusion polypeptide is administered to the human subject to prevent an HIV type 1 (HIV-1), or HIV type 2 (HIV-2) infection.