Method of Producing Novel Unmarked Recombinant Vaccine Vector for Tuberculosis

Tech ID: 20237 / UC Case 2007-715-0


Mycobacterium tuberculosis is a disease that infects millions of people each year; in addition, the related bacterium, Mycobacterium bovis, infects domesticated animals, resulting in substantial economic losses. Currently, humans are administered Bacille Calmette-Guerin (BCG) vaccine to prevent tuberculosis. However, BCG vaccines have variable efficacy - on average about 50%. Recombinant BCG vaccines have been developed that express a key antigen of M. tuberculosis and are more potent than BCG. However, these recombinant BCG vaccines contain antibiotic resistance markers; regulatory authorities want vaccines to be free of such antibiotic resistance markers to diminish their dissemination to other pathogens in the environment. Unmarked vaccine vectors (i.e. those lacking an antibiotic resistance marker) have been produced by various means, but these methods have resulted in low levels of expression of recombinant proteins. Preferably, unmarked strains would not only express large amounts of the recombinant proteins, but express them from genes integrated into the chromosome because such constructs tend to be more stable than when the genes are expressed from a plasmid. Due to safety, potency, regulatory, and stability issues, there is a need for a better vaccine that can prevent and treat tuberculosis in humans and animals.


Investigators at UCLA have identified a method of producing unmarked, live recombinant vaccine vectors that provide high expression of recombinant proteins from genes stably integrated into the chromosome.


  • Treatment and prevention of M. tuberculosis for humans and M. bovis for animals
  • Method for producing a vaccine against leprosy and other mycobacterial diseases


  • Unusually high expression of recombinant protein
  • Unmarked recombinant vaccine vector overcomes regulatory issues surrounding antibiotic resistance markers
  • High stability

State of Development

The vaccine has been tested on animals.

Related Materials

Patent Status

Country Type Number Dated Case
United States Of America Issued Patent 8932846 01/13/2015 2007-715


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  • Horwitz, Marcus A.

Other Information


tuberculosis, recombinant vaccine, unmarked vector, BCG

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