Proteins expressed by Mycobacterium tuberculosis and not by BCG and their use as diagnostic reagents and vaccines
AssigneeRutgers, The State University of New Jersey
InventorMaria Laura Gennaro
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Abstract
The present invention is directed to reagents useful for generating immune responses to Mycobacterium tuberculosis and for diagnosing infection and disease in a subject that has been exposed to M. tuberculosis.
Claims6
An in vivo method of diagnosis which discriminates between exposure of a subject to Mycobacterium tuberculosis and vaccination of a subject with the Bacille Calmette Guerin (BCG) strain of Mycobacterium bovis, the method comprising:
- administering to the skin of the subject a diagnostic reagent containing at least two different antigens having Mycobacterium tuberculosis-specific immunogenic properties, wherein the antigens are isolated polypeptides of the Mycobacterium tuberculosis complex that are not encoded by BCG, said at least two polypeptides including at least one isolated polypeptide selected from the group consisting of (i) a first amino acid sequence comprising the sequence of MTBN4 (SEQ ID NO:
- 4), (ii) a second amino acid sequence that is an antigenic segment of MTBN4, and (iii) a third amino acid sequence that is identical to said first or second amino acid sequence but has conservative substitutions;
- and detecting whether or not there is an immune response to the diagnostic reagent at the site of administration.
An in vivo method of diagnosis which discriminates between exposure of a subject to Mycobacterium tuberculosis and vaccination of a subject with the Bacille Calmette Guerin (BCG) strain of Mycobacterium bovis, the method comprising:
- administering to the subject by intradermal injection a diagnostic reagent containing at least two different antigens having Mycobacterium tuberculosis-specific immunogenic properties, wherein the antigens are isolated polypeptides of the Mycobacterium tuberculosis complex that are not encoded by BCG, said at least two polypeptides including at least one isolated polypeptide selected from the group consisting of (i) a first amino acid sequence comprising the sequence of MTBN4 (SEQ ID NO:
- 4), (ii) a second amino acid sequence that is an antigenic segment of MTBN4, and (iii) a third amino acid sequence that is identical to said first or second amino acid sequence but has conservative substitutions;
- and detecting whether or not there is a delayed-type hypersensitivity response at the site of the intradermal injection.
Dependencies are inferred from the claim text.