# US 8,465,753 B2 · Combination vaccines against Mycobacterium sp. and methods of using the same

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- Number: US 8,465,753 B2
- Document ID: US8465753B2
- Status: Granted
- Kind: B2
- Application number: 12/956,064
- Filed: 2010-11-30
- Published: 2011-03-24
- Granted: 2013-06-18
- Earliest claimed: 2007-04-23
- Applicants: Robert J. Greenstein
- Inventors: Robert J. Greenstein
- Web page: https://patentgrep.com/patent/US8465753B2

## CPC

- A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis
- A61P 31/06: for tuberculosis
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention relates to a combination vaccine against Mycobacterium avium subspecies paratuberculosis (MAP) and M. tuberculosis and/or M. bovis for use in methods of immunizing a subject against mycobacterial infection, preventing or treating mycobacterial infection, and preventing a disease associated with mycobacterial infection.

## Claims

### Claim 1

A method for producing a vaccine for immunizing a subject against Mycobacterium avium subspecies paratuberculosis (MAP) and M. tuberculosis (MTB) infection comprising admixing
(a) at least one isolated and purified MAP antigen, or attenuated or killed MAP, wherein the MAP antigen is GroES, AhpD, 32 kDa antigen, 34 kDa antigen, 34.5 kDa antigen, 35 kDa antigen, 36 kDa antigen, 42 kDa antigen, 44.3 kDa antigen, 65 kDa antigen or AhpC antigen and the attenuated or killed MAP is cell wall-competent or cell wall-deficient;
(b) at least one MTB antigen, or an attenuated or killed MTB; and
(c) a suitable carrier
thereby producing a vaccine for the immunization against MAP and MTB infection.

### Claim 2

A method for immunizing a subject against Mycobacterium avium subspecies paratuberculosis (MAP) and M. tuberculosis (MTB) infection comprising administering to a subject a vaccine containing
(a) at least one isolated and purified MAP antigen, or attenuated or killed MAP, wherein the MAP antigen is GroES, AhpD, 32 kDa antigen, 34 kDa antigen, 34.5 kDa antigen, 35 kDa antigen, 36 kDa antigen, 42 kDa antigen, 44.3 kDa antigen, 65 kDa antigen or AhpC antigen and the attenuated or killed MAP is cell wall-competent or cell wall-deficient; and
(b) at least one MTB antigen, or an attenuated or killed MTB,
thereby immunizing the subject against MAP and MTB infection.

### Claim 3

A method for treating Mycobacterium avium subspecies paratuberculosis (MAP) and M. tuberculosis (MTB) infection comprising administering to a subject a vaccine containing
(a) at least one isolated and purified MAP antigen, or attenuated or killed MAP; and
(b) at least one MTB antigen, or an attenuated or killed MTB,
thereby treating MAP and MTB infection.

### Claim 4 (depends on 3)

The method of claim 3, wherein the attenuated or killed MAP is cell wall-competent or cell wall-deficient.

### Claim 5 (depends on 3)

The method of claim 3, wherein the MAP antigen is GroES, AhpD, 32 kDa antigen, kDa antigen, 34.5 kDa antigen, 35 kDa antigen, 36 kDa antigen, 42 kDa antigen, 44.3 kDa antigen, 65 kDa antigen or AhpC antigen.

### Claim 6 (depends on 3)

The method of claim 3, wherein the subject is a non-human animal.

### Claim 7

A method for preventing a disease associated with Mycobacterium avium subspecies paratuberculosis (MAP) and M. tuberculosis (MTB) infection comprising administering to a subject a vaccine containing
(a) at least one attenuated or killed MAP, wherein the attenuated or killed MAP is cell wall-competent or cell wall-deficient;
(b) at least one MTB antigen, or an attenuated or killed MTB,
thereby preventing a disease associated with MAP and MTB infection.

### Claim 8

A method for preventing a disease associated with Mycobacterium avium subspecies paratuberculosis (MAP) and M. tuberculosis (MTB) infection comprising administering to a subject a vaccine containing
(a) at least one isolated and purified MAP antigen, wherein the MAP antigen is GroES, AhpD, 32 kDa antigen, 34 kDa antigen, 34.5 kDa antigen, 35 kDa antigen, 36 kDa antigen, 42 kDa antigen, 44.3 kDa antigen, 65 kDa antigen or AhpC antigen;
(b) at least one MTB antigen, or an attenuated or killed MTB,
thereby preventing a disease associated with MAP and MTB infection.

### Claim 9

A vaccine comprising
(a) at least one isolated and purified Mycobacterium avium subspecies paratuberculosis (MAP) antigen, or attenuated or killed MAP, wherein the MAP antigen is GroES, AhpD, 32 kDa antigen, 34 kDa antigen, 34.5 kDa antigen, 35 kDa antigen, 36 kDa antigen, 42 kDa antigen, 44.3 kDa antigen, 65 kDa antigen or AhpC antigen and the attenuated or killed MAP is cell wall-competent or cell wall-deficient;
(b) at least one isolated and purified antigen from a member of the M. tuberculosis complex (MTC), or an attenuated or killed mycobacterium from the MTC; and
(c) a suitable carrier.

### Claim 10

A vaccine consisting of:
(a) at least one attenuated or killed Mycobacterium avium subspecies paratuberculosis (MAP), wherein the attenuated or killed MAP is cell wall-competent or cell wall-deficient;
(b) at least one isolated and purified antigen from a member of the M. tuberculosis complex (MTC), or an attenuated or killed mycobacterium from the MTC; and
(c) a suitable carrier.

### Claim 11

A vaccine consisting of:
(a) at least one Mycobacterium avium subspecies paratuberculosis (MAP) antigen, wherein the MAP antigen is GroES, AhpD, 32 kDa antigen, 34 kDa antigen, 34.5 kDa antigen, 35 kDa antigen, 36 kDa antigen, 42 kDa antigen, 44.3 kDa antigen, 65 kDa antigen or AhpC antigen;
(b) at least one isolated and purified antigen from a member of the M. tuberculosis complex (MTC), or an attenuated or killed mycobacterium from the MTC; and
(c) a suitable carrier.