IP Library Granted Patent US 8,563,002
Granted Patent B2
US 8,563,002 · App. 12/810,196 · Granted Oct 22, 2013

Recombinant RSV antigens

Inventors: Guy Jean Marie Fernand Pierre Baudoux (Rixensart, BE); Normand Blais (Lava, CA); Patrick Rheault (Laval, CA); Jean-Louis Ruelle (Rixensart, BE)
Assignee: GlaxoSmithKline Biologicals, S.A.
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Quick Facts
Patent No.
US 8,563,002
App. No.
12/810,196
Granted
Oct 22, 2013
Kind
B2
Abstract

This disclosure provides recombinant respiratory syncytial virus (RSV) antigens and methods for making and using them, including immunogenic compositions (e.g., vaccines) for the treatment and/or prevention of RSV infection.

Claims (28)

1. A recombinant respiratory syncytial virus (RSV) antigen comprising an F2 domain and an F1 domain of an RSV F protein polypeptide with no intervening furin cleavage site wherein the polypeptide further comprises a heterologous trimerization domain positioned C-terminal to the F 1 domain.

2. The recombinant RSV antigen of claim 1 , wherein the F 2 domain comprises at least a portion of an RSV F protein polypeptide corresponding to amino acids 26-105 of the reference F protein precursor polypeptide (F 0 ) of SEQ ID NO:2.

3. The recombinant RSV antigen of claim 1 , wherein the F 1 domain comprises at least a portion of an RSV F protein polypeptide corresponding to amino acids 137-516 of the reference F protein precursor polypeptide (F 0 ) of SEQ ID NO:2.

4. The recombinant RSV antigen of claim 1 , wherein the F 2 domain comprises an RSV F protein polypeptide corresponding to amino acids 26-105 and/or wherein the F 1 domain comprises an RSV F protein polypeptide corresponding to amino acids 137-516 of the reference F protein precursor polypeptide (F 0 ) of SEQ ID NO:2.

5. The recombinant RSV antigen of claim 1 , wherein the RSV antigen is selected from the group of:

a) a polypeptide comprising SEQ ID NO:6;

b) a polypeptide with at least 80% sequence identity to SEQ ID NO:6, which polypeptide comprises an amino acid sequence corresponding to the RSV F protein polypeptide of a naturally occurring RSV strain;

c) a polypeptide with at least 95% sequence identity to SEQ ID NO:6, which polypeptide comprises an amino acid sequence that does not correspond to a naturally occurring RSV strain,

wherein the RSV antigen polypeptide maintains the characteristic of comprising no intervening furin cleavage site between the F2 domain and the F1 domain and comprising a heterologous trimerization domain.

6. The recombinant RSV antigen of claim 1 , further comprising a signal peptide.

7. The recombinant RSV antigen of claim 1 , wherein the heterologous trimerization domain comprises a coiled-coil domain.

8. The recombinant. RSV antigen of claim 7 , wherein the heterologous trimerization domain comprises an isoleucine zipper.

9. The recombinant RSV antigen of claim 1 , wherein the RSV antigen comprises at least one modification selected from:

(i) a deletion of at least one non-furin cleavage site;

(ii) a deletion of one or more amino acids of the pep27 domain; and

(iii) at least one substitution or addition of a hydrophilic amino acid in a hydrophobic domain of the F protein extracellular domain.

10. The recombinant RSV antigen of claim 1 , wherein the RSV antigen comprises a multimer of polypeptides.

11. The recombinant RSV antigen of claim 10 , wherein the RSV antigen comprises a trimer of polypeptides.

12. An immunogenic composition comprising the recombinant RSV antigen of claim 1 , and a pharmaceutically acceptable carrier or excipient.

13. The immunogenic composition of claim 12 , wherein the carrier or excipient comprises a buffer.

14. The immunogenic composition of claim 12 , further comprising an adjuvant

15. The immunogenic composition of claim 14 , wherein the adjuvant comprises at least one of: 3D-MPL, QS21, an oil-in-water emulsion, and an aluminum or calcium salt.

16. The immunogenic composition of claim 12 , wherein the immunogenic composition inhibits infection with Respiratory Syncytial Virus (RSV).

17. The immunogenic composition of claim 12 , further comprising at least one additional antigen of a pathogenic organism other than RSV.

18. A method for eliciting an immune response against Respiratory Syncytial Virus (RSV), the method comprising:

administering to a subject a composition comprising the immunogenic composition of claim 12 .

19. The method of claim 18 , wherein administering the composition comprising the RSV antigen elicits an immune response specific for RSV without enhancing viral disease following contact with RSV.

20. The immunogenic composition of claim 15 , wherein the adjuvant comprises 3D-MPL and Alum.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 18, 2023
From: ID BIOMEDICAL CORPORATION OF QUEBEC
To: GLAXOSMITHKLINE BIOLOGICALS SA
Reel/Frame 064296/0801 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 17, 2023
From: ID BIOMEDICAL CORPORATION OF QUEBEC
To: GLAXOSMITHKLINE BIOLOGICALS SA
Reel/Frame 064279/0842 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 8, 2013
From: BAUDOUX, GUY JEAN MARIE FERNAND PIERRE; RUELLE, JEAN-LOUIS; BLAIS, NORMAND; RHEAULT, PATRICK
To: GLAXOSMITHKLINE BIOLOGICALS S.A.; ID BIOMEDICAL CORPORATION OF QUEBEC
Reel/Frame 030967/0529 →
Continuity (3)
Provisional Application 61016524 · Dec 24, 2007
Provisional Application 61056206 · May 27, 2008
Related Publication 20100291147A1 · Nov 18, 2010