Statens Serum Institut

Karin Weldingh

Peter Andersen

Peter Birk Rasmussen

Walter Florio

Rikke Louise Vinther Skjot

Li Mei Meng Okkels

Christina Veggerby Hansen

Ida Rosenkrands

Thomas Oettinger

Inger Brock

Rikke Nielsen

The present invention is based on the identification and characterization of a number of novelderived proteins and protein fragments. The invention is directed to the polypeptides and immunologically active fragments thereof, the genes encoding them, immunological compositions such as diagnostic reagents containing the polypeptides.

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The currently used method for immunological diagnosis of tuberculosis infection, the tuberculin skin test, is problematic for a number of reasons; it has low specificity in BCG vaccinated individuals, a high interobserver variance and requires skill to be read and interpreted. Furthermore it requires an extra visit to the clinic to have the test read. Both people vaccinated with BCG and those exposed to non-tuberculosis mycobacteria give a positive skin test result similar to that seen in a TB infected individual. This also applies for purified protein derivative (PPD) when used in a blood cell based test. The present invention discloses the development of an immunological TB diagnostic tool based on a combination of epitopes from proteins encoded by regions of the(M. tub.) genome, that are not present in the BCG vaccine strain or in the most common non-tuberculosis mycobacteria.

Specific epitope based immunological diagnosis of tuberculosis

TB diagnostic based on antigens from M. tuberculosis

The present invention is based on the identification and characterization of a number of derived novel proteins and protein fragments (SEQ ID NOs: 2, 4, 6, 8, 10, 12, 14, 16, 17-23, 42, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72-86, 88, 90, 92, 94, 141, 143, 145, 147, 149, 151, 153, and 168-171). The invention is directed to the polypeptides and immunologically active fragments thereof, the genes encoding them, immunological compositions such as vaccines and skin test reagents containing the polypeptides. Another part of the invention is based on the surprising discovery that fusions between ESAT-6 and MPT59 are superior immunogens compared to each of the unfused proteins, respectively.

Nucleic acids fragments and polypeptide fragments derived from M. tuberculosis

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Vaerlose, Denmark

Karin Weldingh