Claims for Patent: 7,700,118

Summary for Patent: 7,700,118

Title:	Molecular differences between species of the M. tuberculosis complex
Abstract:	Specific genetic deletion are identified in mycobacteria isolates, including variations in the M. tuberculosis genome sequence between isolates, and numerous deletion present in BCG as compared to M. tb. These deletions are used as markers to distinguish between pathogenic and avirulent strains, and as a marker for particular M. tb isolates. Deletions specific to vaccine strains of BCG are useful in determining whether a positive tuberculin skin test is indicative of actual tuberculosis infection. The deleted sequences may be re-introduced into BCG to improve the efficacy of vaccination. Alternatively, the genetic sequence that corresponds to the deletion(s) are deleted from M. bovis or M. tubercuosis to attenuate the pathogenic bacteria.
Inventor(s):	Behr; Marcel (Montreal, CA), Small; Peter (Seattle, WA), Schoolnik; Gary (Stanford, CA), Wilson; Michael A. (Austin, TX)
Assignee:	The Board of Trustees of the Leland Stanford Junior University (Palo Alto, CA)
Application Number:	12/049,063
Patent Claims:	1. An immunogenic composition, comprising: a substantially pure polypeptide encoded by open reading frame Rv2659c, SEQ ID NO:99 or a polypeptide encoded by a nucleotide fragment of at least 25 contiguous nucleotides of SEQ ID NO:99 or where said polypeptide is fused to another peptide or protein; and a pharmaceutically acceptable excipient. 2. The immunogenic composition according to claim 1, further comprising an adjuvant. 3. The immunogenic composition according to claim 1, wherein said polypeptide is fused to another peptide or protein. 4. A method of immunizing an individual to M. tuberculosis, the method comprising: injecting said individual with a mycobacterium of the M. tuberculosis complex that has been modified to introduce a nucleotide sequence comprising the open reading frame Rv2659c, SEQ ID NO:99 or a polypeptide encoded by a nucleotide fragment of at least 25 contiguous nucleotides of SEQ ID NO:99, wherein said mycobacterium of the M. tuberculosis complex is bacillus Calmette-Guerin. 5. A method of immunizing an individual to M. tuberculosis, the method comprising: injecting said individual with a polypeptide encoded by open reading frame Rv2659c, SEQ ID NO:99 or a polypeptide encoded by a nucleotide fragment of at least 25 contiguous nucleotides of SEQ ID NO:99 or where said polypeptide is fused to another peptide or protein. 6. A genetically altered mycobacterium of the M. tuberculosis complex, comprising an exogenous nucleic acid sequence comprising the open reading frame Rv2659c, SEQ ID NO:99 or a polypeptide encoded by a nucleotide fragment of at least 25 contiguous nucleotides of SEQ ID NO:99. 7. The genetically altered mycobacterium of claim 6, wherein said exogenous nucleic acid encodes a polypeptide that is fused to another peptide or protein. 8. The genetically altered mycobacterium of claim 6, wherein said mycobacterium is BCG. 9. The mycobacterium of claim 6, and a physiologically acceptable carrier for injection.

Details for Patent 7,700,118

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	06/21/1989		2040-01-28