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Albert Einstein College of Medicine

Svetoslav Bardarov, Legal Representative

William R Jacobs, Jr

Stoyan S Bardarov

Tsungda Hsu

Vasan Sambandamurthy

Sheldon Morris

Methods of treating a mammal that is deficient in CD4and/or CD8lymphocytes are provided. The methods comprise inoculating the mammal with an attenuated mycobacterium in thecomplex. In these methods, the mycobacterium comprises two deletions, wherein a virulent mycobacterium in thecomplex having either deletion exhibits attenuated virulence. Use of these mycobacteria for the manufacture of a medicament for the treatment of mammals deficient in CD4and/or CD8lymphocytes is also provided.

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Non-naturally occurring mycobacteria in thecomplex are provided. These mycobacteria have a deletion of an RD1 region or a region controlling production of a vitamin, and exhibit attenuated virulence in a mammal when compared to the mycobacteria without the deletion. Also provided are non-naturally occurring mycobacteria that have a deletion of a region controlling production of lysine, and mycobacteria comprising two attenuating deletions. Vaccines comprising these mycobacteria are also provided, as are methods of protecting mammals from virulent mycobacteria using the vaccines. Also provided are methods of preparing these vaccines which include the step of deleting an RD1 region or a region controlling production of a vitamin from a mycobacterium in thecomplex.

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Worcester, MA, United States of America

Svetoslav Bardarov, Legal Representative