Methods and compositions for inducing protective immunity against human immunodeficiency virus infection

Patent metadata

Field	Value
Publication number	US-10137191-B2
Application number	US-201514863808-A
Country	US
Kind code	B2
Filing date	Sep 24, 2015
Priority date	Sep 26, 2014
Publication date	Nov 27, 2018
Grant date	Nov 27, 2018

Abstract

Compositions, vaccines and methods for inducing protective immunity against Human Immunodeficiency Virus (HIV) infection are described. Heterologous vaccine combinations of one or more viral expression vectors and an isolated antigenic polypeptide induced strong protective immunity against infections by one or multiple clades of HIV.

First claim

What is claimed is:

1. A vaccine combination for inducing an immune response against a human immunodeficiency virus (HIV) in a subject, comprising:
(i) a primer composition comprising an immunogenically effective amount of one or more adenovirus 26 (rAd26) vectors encoding one or more HIV antigenic polypeptides comprising amino acid sequences selected from the group consisting of SEQ ID NOs: 1-4, and a pharmaceutically acceptable carrier;
(ii) a first booster composition comprising an immunogenically effective amount of an isolated HIV envelope polypeptide comprising at least one of a stabilized trimer of HIV gp140 comprising the amino acid sequence of SEQ ID NO: 5 and a stabilized trimer of HIV gp140 comprising the amino acid sequence of SEQ ID NO: 6, and a pharmaceutically acceptable carrier; and
(iii) a second booster composition comprising an immunogenically effective amount of one or more additional rAd26 vectors encoding one or more additional HIV antigenic polypeptides comprising amino acid sequences selected from the group consisting of SEQ ID NOs: 1-4, and a pharmaceutically acceptable carrier,
wherein the first booster composition is for administration together with the second booster composition to the subject after administration of the primer composition.

2. The vaccine combination according to claim 1 , wherein the first and second booster compositions are present in separate compositions.

3. A kit comprising the vaccine combination of claim 1 .

4. The vaccine combination according to claim 1 , wherein the adenovirus 26 vectors are replication deficient.

5. The vaccine combination according to claim 1 , wherein the isolated HIV envelope polypeptide comprises a stabilized trimer of HIV gp140 comprising the amino acid sequence of SEQ ID NO: 6.

6. The vaccine combination according to claim 1 , wherein the first booster composition further comprises an adjuvant comprising aluminum phosphate.

7. A vaccine combination for inducing an immune response against a human immunodeficiency virus (HIV) in a subject, comprising:
(i) a primer composition comprising an immunogenically effective amount of adenovirus 26 (rAd26) vectors encoding three HIV antigenic polypeptides comprising the amino acid sequences of SEQ ID NO: 1, SEQ ID NO: 3 and SEQ ID NO: 4, and a pharmaceutically acceptable carrier;
(ii) a first booster composition comprising an immunogenically effective amount of an isolated HIV envelope polypeptide comprising a stabilized trimer of HIV gp140 having the amino acid sequence of SEQ ID NO: 5, and a pharmaceutically acceptable carrier; and
(iii) a second booster composition comprising an immunogenically effective amount of rAd26 vectors encoding three HIV antigenic polypeptides comprising the amino acid sequences of SEQ ID NO: 1, SEQ ID NO: 3 and SEQ ID NO: 4, and a pharmaceutically acceptable carrier,
wherein the first booster composition is for administration together with the second booster composition to the subject after administration of the primer composition.

8. The vaccine combination according to claim 7 , wherein the first and second booster compositions are present in separate compositions.

9. The vaccine combination according to claim 7 , wherein the rAd26 vectors are replication deficient.

10. A kit comprising the vaccine combination of claim 7 .

11. The vaccine combination according to claim 7 , wherein the rAd26 vectors in the primer composition and the second booster composition consist of three rAd26 vectors of which a first rAd26 vector encodes an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO: 1, a second rAd26 vector encodes an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO: 3, and a third rAd26 vector encodes an HIV antigenic polypeptide comprising the amino acid sequence of SEQ ID NO: 4.

12. The vaccine combination according to claim 7 , wherein the first booster composition further comprises an adjuvant comprising aluminum phosphate.

13. The vaccine combination according to claim 7 , wherein the immunogenically effective amount of an isolated HIV envelope polypeptide further comprises a stabilized trimer of HIV gp140 having the amino acid sequence of SEQ ID NO: 6.

14. The vaccine combination according to claim 1 , wherein the isolated HIV envelope polypeptide comprises a stabilized trimer of HIV gp140 comprising the amino acid sequence of SEQ ID NO: 5.

Assignees

• Beth Israel Deaconess Medical Ct Inc
• Janssen Vaccines & Prevention Bv

Inventors

• Barouch Dan
• Schuitemaker Johanna
• Pau Maria Grazia
• Van Manen Danielle
• Tomaka Frank
• Hendriks Jennifer Anne

Classifications

• A61P31/18

  for HIV · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P37/04

  Immunostimulants · CPC title

• A61K39/12 Primary

  Viral antigens · CPC title

• C12N2710/10043

  viral genome or elements thereof as genetic vector · CPC title