Compositions and Vaccine Combinations Containing Synthetic Human Immunodeficiency Virus (HIV) Envelope Antigen, and Methods of Use Thereof

• US 20190321462A1
• Filed: 06/13/2019
• Published: 10/24/2019
• Est. Priority Date: 12/15/2015
• Status: Active Grant

• Current Assignee: Janssen Vaccines & Prevention B.V. (Johnson & Johnson)
• Original Assignee: Janssen Vaccines & Prevention B.V. (Johnson & Johnson)
• Inventors: LANGEDIJK, Johannes Petrus Maria, VAN MANEN, Danielle, VELLINGA, Jort, WEGMANN, Frank, CALLENDRET, Benoit Christophe Stephan, KRARUP, Anders, STITZ, Jorn
• Granted Patent: US 10,973,907 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 2039/5256 expressing foreign proteins
• CPC Class Codes: A61K 39/21 Retroviridae, e.g. equine infectious anemia virus
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 14/005 from viruses
• CPC Class Codes: C07K 14/162 env, e.g. gp160, gp110/120, gp41, V3, peptid T, CD4-Binding site
• CPC Class Codes: C12N 15/86 Viral vectors
• CPC Class Codes: C12N 15/861 Adenoviral vectors
• CPC Class Codes: C12N 2710/10343 viral genome or elements thereof as genetic vector
• CPC Class Codes: C12N 2740/16111 concerning HIV env
• CPC Class Codes: C12N 2740/16122 New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
• CPC Class Codes: C12N 2740/16134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2740/16171 Demonstrated in vivo effect
• CPC Class Codes: C12N 2740/16234 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 7/00 Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00

Abstract

Compositions and vaccine combinations containing synthetic HIV envelope proteins, and methods for inducing an immune response against human immunodeficiency virus (HIV) infection are described. Viral expression vectors encoding the synthetic HIV envelope proteins can be used in the vaccine combinations to induce immune responses against HIV and provide improved protective immunity against HIV.

Claims

1. A vaccine combination, comprising:

(i) a first composition comprising an immunogenically effective amount of an adenovirus vector encoding a synthetic HIV envelope protein having the amino acid sequence of SEQ ID NO;

8, or SEQ ID NO;

8 having one or more mutations selected from the group consisting of (i) I529P, (ii) K480E, and (iii) a combination of EK479-480RRRR, I529P, A471C and T575C; and

(ii) a second composition comprising an immunogenically effective amount of a second adenovirus vector encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO;

5,

wherein the first composition and second composition are present in the same composition or in different compositions.

2. The vaccine combination of claim 1, wherein the first composition comprises an immunogenically effective amount of an adenovirus vector encoding a synthetic HIV envelope protein comprising the amino acid sequence of SEQ ID NO:

18.

3. The vaccine combination of claim 1, wherein the adenovirus vector in the first composition is an adenovirus 26 (Ad26) vector.

4. The vaccine combination of claim 2, wherein the adenovirus vector in the first composition is an Ad26 vector.

5. The vaccine combination of claim 1, wherein the second adenovirus vector in the second composition is a second Ad26 vector.

6. The vaccine combination of claim 4, wherein the second adenovirus vector in the second composition is a second Ad26 vector.

12. The vaccine combination of claim 1, wherein the first composition and the second composition are present in the same composition.

13. The vaccine combination of claim 2, wherein the first composition and the second composition are present in the same composition.

20. A method of inducing an immune response against a human immunodeficiency virus (HIV) in a subject in need thereof, the method comprising administering to the subject the vaccine combination of claim 1.

22. The vaccine combination of claim 2, further comprising an additional composition comprising an adenovirus vector comprising nucleic acid encoding an HIV antigenic polypeptide comprising the amino acid sequence selected from the group consisting of SEQ ID NOs:

1-4, 28, and 29, wherein the first composition, second composition and additional composition are present in the same composition.

23. The vaccine combination of claim 2, further comprising an additional composition comprising an adenovirus vector comprising nucleic acid encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO:

28 and an adenovirus vector comprising nucleic acid encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO;

29, wherein the first composition, second composition, and additional composition are present in the same composition.

7. A vaccine combination comprising:

(i) a first composition comprising an immunogenically effective amount of an adenovirus 26 (Ad26) vector encoding a synthetic HIV envelope protein having the amino acid sequence of SEQ ID NO;

8, or SEQ ID NO;

8 having one or more mutations selected from the group consisting of (i) I529P, (ii) K480E, and (iii) a combination of EK479-480RRRR, I529P, A471C and T575C;

(ii) a second composition comprising an immunogenically effective amount of a second Ad26 encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO;

5; and

(iii) at least one additional composition comprising an immunogenically effective amount of at least one selected from the group consisting of;

(iiia) a vector encoding at least one antigenic polypeptide having the amino acid sequence selected from the group consisting of SEQ ID NOs;

1-4, 28 and 29, and

(iiib) a polypeptide comprising an immunogenically effective amount of an isolated HIV antigenic polypeptide having residues 30-708 of the amino acid sequence of SEQ ID NO;

7, or residues 30-724 of the amino acid sequence of SEQ ID NO;

36,

wherein the first composition, second composition and additional composition are present in the same composition or in one or more different compositions.

8. The vaccine combination of claim 7, wherein the synthetic HIV envelope protein encoded by the Ad26 vector in the first composition comprises the amino acid sequence of SEQ ID NO:

18.

9. The vaccine combination of claim 7, further comprising an immunogenically effective amount of an Ad26 vector encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO:

28.

10. The vaccine combination of claim 7, further comprising an immunogenically effective amount of an Ad26 vector encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO:

29.

11. The vaccine combination of claim 7, comprising:

(i) a first composition comprising an Ad26 vector encoding a synthetic HIV envelope protein comprising the amino acid sequence of SEQ ID NO;

18;

(ii) a second composition comprising a second Ad26 encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO;

5; and

(iii) at least one additional composition comprising an immunogenically effective amount of;

(iiia) a third Ad26 vector encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO;

28;

(iiib) a fourth Ad26 vector encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO;

29; and

(iiic) a polypeptide comprising an immunogenically effective amount of an isolated HIV antigenic polypeptide having residues 30-708 of the amino acid sequence of SEQ ID NO;

7, or residues 30-724 of the amino acid sequence of SEQ ID NO;

36,

wherein the first composition, second composition and additional composition are present in the same composition or in one or more different compositions.

14. The vaccine combination of claim 7, wherein the additional composition comprises a vector encoding at least one antigenic polypeptide having the amino acid sequence selected from the group consisting of SEQ ID NOs:

1-4, 28 and 29, and wherein the first composition, the second composition, and the additional composition are present in the same composition.

15. The vaccine combination of claim 14, wherein the vector in the additional composition is an Ad26 vector.

16. The vaccine combination of claim 14, wherein the additional composition comprises a third vector encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO:

28 and a fourth vector encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO;

29, and wherein the first composition, the second composition, and the additional composition are present in the same composition.

17. The vaccine combination of claim 16, wherein each of the third vector and fourth vector is an Ad26 vector.

18. The vaccine combination of claim 7, wherein the additional composition comprises a polypeptide comprising an immunogenically effective amount of an isolated HIV antigenic polypeptide having residues 30-708 of the amino acid sequence of SEQ ID NO:

7, or residues 30-724 of the amino acid sequence of SEQ ID NO;

36, wherein the first composition and second composition are present in the same composition, and the additional composition is present in a different composition.

19. The vaccine combination of claim 18, wherein the additional composition comprises an isolated HIV antigenic polypeptide having residues 30-708 of the amino acid sequence of SEQ ID NO:

7 and an isolated HIV antigenic polypeptide having residues 30-724 of the amino acid sequence of SEQ ID NO;

36.

21. A method of inducing an immune response against a human immunodeficiency virus (HIV) in a subject in need thereof, the method comprising:

(i) administering to the subject a first composition comprising a first adenovirus 26 (Ad26) vector encoding a synthetic HIV envelope protein comprising the amino acid sequence of SEQ ID NO;

18, a second composition comprising a second Ad26 vector encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO;

5, wherein the first composition and second composition are present in the same or different compositions;

(ii) administering to the subject a third composition comprising a polypeptide comprising an immunogenically effective amount of an isolated HIV antigenic polypeptide having residues 30-708 of the amino acid sequence of SEQ ID NO;

7, or residues 30-724 of the amino acid sequence of SEQ ID NO;

36, and

(iii) optionally administering to the subject one or more additional vectors encoding at least one antigenic polypeptide having the amino acid sequence selected from the group consisting of SEQ ID NOs;

1-4, 28 and 29,

wherein the one or more additional vectors are included in the first composition or the second composition or one or more additional compositions to be administered with the first composition, the second composition, and/or the third composition.

24. A composition comprising:

(i) a first adenovirus 26 (Ad26) vector encoding a synthetic HIV envelope protein comprising the amino acid sequence of SEQ ID NO;

18;

(ii) a second Ad26 vector encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO;

5;

(iii) a third Ad26 vector encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO;

28; and

(iv) a fourth Ad26 vector encoding an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO;

29.

25. The composition of claim 24, wherein the first, second, third and fourth Ad26 vectors are present in a viral particle ratio of 1:

1;

1;

1.

26. A vaccine combination, comprising:

(a) a first composition which is the composition of claim 24; and

(b) a second composition comprising;

(b, i) an isolated HIV antigenic polypeptide having residues 30-708 of the amino acid sequence of SEQ ID NO;

7, or

(b, ii) an isolated HIV antigenic polypeptide having residues 30-724 of the amino acid sequence of SEQ ID NO;

36, or

(b, iii) an isolated HIV antigenic polypeptide having residues 30-708 of the amino acid sequence of SEQ ID NO;

7 and an isolated HIV antigenic polypeptide having residues 30-724 of the amino acid sequence of SEQ ID NO;

36.

27. The vaccine combination of claim 26, wherein the second composition comprises an isolated HIV antigenic polypeptide having residues 30-708 of the amino acid sequence of SEQ ID NO:

7.

28. The vaccine combination of claim 26, wherein the second composition comprises an isolated HIV antigenic polypeptide having residues 30-708 of the amino acid sequence of SEQ ID NO:

7 and an isolated HIV antigenic polypeptide having residues 30-724 of the amino acid sequence of SEQ ID NO;

36.

29. A method for immunizing a subject, comprising administering to the subject the composition of claim 24.