IP Library Granted Patent US 10,716,845
Granted Patent B2
US 10,716,845 · App. 15/026,391 · Granted Jul 21, 2020

Stabilized human immunodeficiency virus (HIV) clade C envelope (Env) trimer vaccines and methods of using same

Inventors: Dan H. Barouch (Newton, MA); Christine Bricault (Boston, MA)
Assignee: Beth Israel Deaconess Medical Center, Inc.
A61K39/21A61K39/12C07K14/162C12N7/00A61K2039/545A61K2039/55561A61K2039/55566A61K2039/575A61K2039/70C07K2319/00C12N2740/15034C12N2740/16022C12N2740/16034C12N2740/16071C12N2740/16111C12N2740/16122C12N2740/16134C12N2740/16171
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Quick Facts
Patent No.
US 10,716,845
App. No.
15/026,391
Granted
Jul 21, 2020
Kind
B2
Abstract

The invention features stabilized human immunodeficiency virus (H IV) clade C envelope (Env) trimers. The invention also features vaccines, nucleic acids, and vectors to deliver and/or facilitate production of the stabilized HIV clade C Env trimers. In addition, the invention features methods of making and using the stabilized HIV clade C Env trimers of the invention.

Claims (25)

1. An immunogenic composition comprising a gp140 polypeptide, wherein the polypeptide comprises:

(a) at least 90% sequence identity over the entire length of SEQ ID NO: 1 and has a V1/V2 epitope corresponding to amino acids 166-183 of SEQ ID NO: 1 and a V3 epitope corresponding to amino acids 342-348 of SEQ ID NO: 1;

(b) at least 90% sequence identity over the entire length of SEQ ID NO: 2 and has a V1/V2 epitope corresponding to amino acids 155-172 of SEQ ID NO: 2 and a V3 epitope corresponding to amino acids 330-335 of SEQ ID NO: 2; or

(c) at least 90% sequence identity over the entire length of SEQ ID NO: 3 and has a V1/V2 epitope corresponding to amino acids 150-167 of SEQ ID NO: 3 and a V3 epitope corresponding to amino acids 328-334 of SEQ ID NO: 3;

wherein the polypeptide is capable of inducing a neutralizing antibody response.

2. The immunogenic composition of claim 1 comprising a stabilized trimer of the gp140 polypeptide, wherein each of the gp140 polypeptides of the stabilized trimer has the same amino acid sequence.

3. The immunogenic composition of claim 2 comprising at least two different stabilized trimers.

4. The immunogenic composition of claim 2 , wherein the amino acid sequence of each of the gp140 polypeptides of the stabilized trimer has at least 95% sequence identity over the entire length of any one of SEQ ID NOs: 1, 2, and 3.

5. The immunogenic composition of claim 2 , wherein said composition further comprises a stabilized C97ZA012 gp140 trimer.

6. The immunogenic composition of claim 1 , further comprising: (i) a pharmaceutically acceptable carrier, excipient, or diluent, and/or (ii) an adjuvant.

7. A kit comprising:

(a) the immunogenic composition of claim 1 ;

(b) a pharmaceutically acceptable carrier, excipient, or diluent; and

(c) instructions for use thereof, wherein said kit optionally includes an adjuvant.

8. The immunogenic composition of claim 1 , wherein the amino acid sequence of the gp140 polypeptide has at least 95% sequence identity over the entire length of SEQ ID NO: 1, 2, or 3.

9. The immunogenic composition of claim 8 , wherein the amino acid sequence of the gp140 polypeptide comprises the amino acid sequence of SEQ ID NO: 1, 2, or 3.

10. The immunogenic composition of claim 4 , wherein the amino acid sequence of each of the gp140 polypeptides of the stabilized trimer has at least 99% sequence identity-over the entire length of any one of SEQ ID NOs: 1, 2, and 3.

11. The immunogenic composition of claim 10 , wherein each of the gp140 polypeptides of the stabilized trimer comprises the amino acid sequence of any one of SEQ ID NOs: 1, 2, and 3.

12. The immunogenic composition of claim 8 , wherein the amino acid sequence of the gp140 polypeptide has at least 99% sequence identity over the entire length of SEQ ID NO: 1, 2, or 3.

13. The immunogenic composition of claim 1 , wherein the polypeptide of (a) further comprises one or more of amino acids 121-128, 287-295, 375-386, 434-441, 462-468, or 478-486 of SEQ ID NO: 1.

14. The immunogenic composition of claim 1 , wherein the polypeptide of (b) further comprises one or more of amino acids 121-128, 275-283, 361-372, 408-415, 436-442, or 455-463 of SEQ ID NO: 2.

15. The immunogenic composition of claim 1 , wherein the polypeptide of (c) further comprises one or more of amino acids 121-128, 273-281, 361-372, 419-426, 447-453, or 466-474 of SEQ ID NO: 3.

16. The immunogenic composition of claim 1 , wherein the polypeptide of (a) further comprises amino acids 121-128, 287-295, 375-386, 434-441, 462-468, and 478-486 of SEQ ID NO: 1.

17. The immunogenic composition of claim 1 , wherein the polypeptide of (b) further comprises amino acids 121-128, 275-283, 361-372, 408-415, 436-442, and 455-463 of SEQ ID NO: 2.

18. The immunogenic composition of claim 1 , wherein the polypeptide of (c) further comprises amino acids 121-128, 273-281, 361-372, 419-426, 447-453, and 466-474 of SEQ ID NO: 3.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 18, 2017
From: BAROUCH, DAN H.; BRICAULT, CHRISTINE
To: BETH ISRAEL DEACONESS MEDICAL CENTER, INC.
Reel/Frame 042039/0485 →
CONFIRMATORY LICENSE Recorded Jul 13, 2016
From: BETH ISRAEL DEACONESS MEDICAL CENTER
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 039326/0709 →
Continuity (2)
Provisional Application 61886932 · Oct 4, 2013
Related Publication 20160243215A1 · Aug 25, 2016