IP Library Patent Application 15110932
Patent Application
App. No. 15/110,932

MYCOBACTERIAL ANTIGEN COMPOSITION

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Patent No.
US None
App. No.
15/110,932
Abstract

The present invention provides an antigenic composition for use as a mycobacterial vaccine, said composition comprising (i) a first mycobacterial antigenic polypeptide, wherein said first mycobacterial antigenic polypeptide comprises a polypeptide sequence having at least 70% amino acid sequence identity to the amino acid sequence of SEQ ID NO: 6, 12, 2, 18, 8, 10, 6, 4, or a fragment thereof having at least 50 consecutive amino acids thereof; or (ii) a first mycobacterial polynucleotide, wherein said first mycobacterial polynucleotide comprises a polynucleotide sequence encoding said first mycobacterial antigenic polypeptide, or 10 wherein said first mycobacterial polynucleotide comprises a polynucleotide sequence selected from SEQ ID NO: 5, 11, 1, 17, 7, 9, 15, 3.

Claims (35)

1 . An antigenic composition comprising either:

(i) a first mycobacterial antigenic polypeptide, wherein said first mycobacterial antigenic polypeptide comprises a polypeptide sequence having at least 90% amino acid sequence identity to the amino acid sequence of SEQ ID NO: 6, 12, 2, 18, 8, 10, 16, 4, or a fragment thereof having at least 150 consecutive amino acids thereof, wherein said fragment has a common antigenic cross-reactivity with a polypeptide selected from SEQ ID NOs: 6, 12, 2, 18, 8, 10, 16, 4; or

(ii) a first mycobacterial polynucleotide, wherein said first mycobacterial polynucleotide comprises a polynucleotide sequence encoding said first mycobacterial antigenic polypeptide, or wherein said first mycobacterial polynucleotide comprises a polynucleotide sequence selected from SEQ ID NO: 5, 11, 1, 17, 7, 9, 15, 3;

wherein said antigenic composition is for use in treating, suppressing or preventing a mycobacterial infection in a subject.

2 . The antigenic composition according to claim 1 , wherein said first mycobacterial polynucleotide comprises a polynucleotide sequence having at least 90% nucleotide sequence identity to the nucleic acid sequence of SEQ ID NO: 5, 11, 1, 17, 7, 9, 15, 3, or a fragment thereof having at least 450 consecutive nucleotides thereof, wherein said fragment encodes a polypeptide that has a common cross-reactivity with a polypeptide selected from SEQ ID NOs: 6, 12, 2, 18, 8, 10, 16, 4.

3 . The antigenic composition according to claim 1 , further comprising at least one additional (second) mycobacterial polypeptide, which is different from said first mycobacterial antigenic polypeptide; or at least one additional (second) mycobacterial polynucleotide encoding a second mycobacterial antigenic polypeptide, wherein said second mycobacterial polypeptide is different from said first mycobacterial polypeptide.

4 . The antigenic composition according to claim 1 , wherein said antigenic composition comprises at least one vector and wherein said mycobacterial polynucleotide(s) is/are incorporated into said at least one vector.

5 . The antigenic composition according to claim 4 , wherein said vector is an expression vector or a viral vector.

6 . The antigenic composition according to claim 1 , wherein said antigenic composition comprises at least one cell, and wherein said cell comprises at least one of said mycobacterial antigenic polypeptides and/or mycobacterial polynucleotides.

7 . A method for producing a therapeutic or prophylactic formulation, the method comprising combining a pharmaceutically acceptable carrier with either:

(i) mycobacterial antigenic polypeptide according to claim 1 ; or

(ii) a first mycobacterial polynucleotide according to claim 1 .

8 . (canceled)

9 . An in vitro method of diagnosing a mycobacterial infection, comprising incubating a test sample containing an immune cell such as a T-lymphocyte from a subject with:

(a) antigenic composition according to claim 1 ; or

(b) a first mycobacterial antigenic polypeptide or first mycobacterial polynucleotide according to claim 1 ;

and detecting for activation of said immune cell, wherein activation of said immune cell is indicative of a mycobacterial infection in the subject.

10 . An in vitro method of diagnosing a mycobacterial infection, comprising incubating a test sample from a subject with:

(a) antigenic composition according to any of claim 1 ; or

(b) a first mycobacterial antigenic polypeptide or first mycobacterial polynucleotide according to claim 1 ;

wherein said incubating is performed under conditions that allow binding of said first mycobacterial antigen with antibodies in the sample to form antigen-antibody complexes; and then detecting for the formation of such complexes, wherein the presence of antigen-antibody complexes is indicative of a mycobacterial infection in the subject.

11 . An in vitro method of diagnosing a mycobacterial infection, comprising incubating a test sample from a subject with:

(a) an antigenic/immunogenic composition according to claim 1 ; or

(b) a first antibody, wherein said first antibody binds a first mycobacterial antigenic polypeptide according to claim 1 ;

wherein said incubating is performed under conditions that allow binding of said first and second antibodies with antigens in the sample to form antigen-antibody complexes; and then detecting for the formation of such complexes, wherein the presence of antigen-antibody complexes is indicative of a mycobacterial infection in the subject.

12 . A method for treating, suppressing or preventing a mycobacterial infection in a subject, said method comprising administering an antigenic composition according to any of claim 1 to said subject.

13 . The antigenic composition of claim 4 , wherein said vector is a plasmid.

14 . The antigenic composition of claim 5 , wherein said viral vector is an attenuated vaccinia virus vector or an adenoviral vector.

15 . The antigenic composition of claim 6 , wherein said cell is an attenuated microbial carrier.

16 . The antigenic composition of claim 15 , wherein said attenuated microbial carrier is attenuated salmonella , attenuated M. bovis or attenuated M. tuberculosis.

17 . The antigenic composition of claim 16 , wherein said attenuated M. bovis is a BCG strain of M. bovis.

18 . The method of claim 7 , wherein said formulation is a vaccine.

19 . The method of claim 9 , wherein said mycobacterial infection is an early stage mycobacterial infection.

20 . The method of claim 10 , wherein said mycobacterial infection is an early stage mycobacterial infection.

21 . The method of claim 11 , wherein said mycobacterial infection is an early stage mycobacterial infection.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 25, 2016
From: HALL, YPER; BACON, JOANNA; MARSH, PHILIP
To: THE SECRETARY OF STATE FOR HEALTH
Reel/Frame 040117/0018 →