US 12,070,493 B1
Double auxotrophic mycobacterium and uses thereof
William R. Jacobs, Jr., Pelham, NY (US); and Sangeeta Tiwari, Bronx, NY (US)
Assigned to ALBERT EINSTEIN COLLEGE OF MEDICINE, Bronx, NY (US)
Filed by Albert Einstein College of Medicine, Bronx, NY (US)
Filed on Apr. 27, 2023, as Appl. No. 18/307,998.
Application 18/307,998 is a division of application No. 17/268,789, granted, now 11,666,648, previously published as PCT/US2019/046703, filed on Aug. 15, 2019.
Claims priority of provisional application 62/764,696, filed on Aug. 15, 2018.
Int. Cl. A61K 39/04 (2006.01); A61P 37/04 (2006.01); C12N 15/52 (2006.01); C12Q 1/68 (2018.01); C12Q 1/6897 (2018.01); A61K 39/00 (2006.01)
CPC A61K 39/04 (2013.01) [A61P 37/04 (2018.01); C12N 15/52 (2013.01); C12Q 1/6897 (2013.01); A61K 2039/522 (2013.01)] 4 Claims
 
1. A method of determining the efficacy of a candidate tuberculosis vaccine, comprising:
administering the candidate tuberculosis vaccine to an animal which has been infected with an auxotrophic Mycobacterium comprising a mycobacterial genome in which (i) argB gene, or a gene encoding a mycobacterial ArgB enzyme, has been fully or partially deleted and (ii) metA gene, or a gene encoding a mycobacterial MetA enzyme, has been fully or partially deleted, wherein the Mycobacterium is sterilized in the absence of arginine and methionine),
quantifying the amount of the auxotrophic Mycobacterium in the animal at one or more time points subsequent to administering the candidate tuberculosis vaccine, and
comparing the amount of auxotrophic Mycobacterium quantified to a predetermined control amount, or to the amount of auxotrophic Mycobacterium infected into the animal, so as to determine the efficacy of the candidate tuberculosis vaccine.