US2023330201A1PendingUtilityA1

Compositions for use as a prophylactic agent to those at risk of infection of tuberculosis, or as secondary agents for treating infected tuberculosis patients

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Assignee: UNIV ZARAGOZAPriority: Feb 19, 2018Filed: Apr 28, 2023Published: Oct 19, 2023
Est. expiryFeb 19, 2038(~11.6 yrs left)· nominal 20-yr term from priority
Inventors:Carlos Martín MontañesJuan Ignacio Aguiló AnentoJesús Ángel Gonzalo AsensioDessislava Vaneva MarinovaSantiago Uganda MaízEsteban Rodríguez SánchezEugenia Puentes ColoradoConcepción Fernández Álvarez-Santullano
A61K 39/04A61P 37/04C12N 1/20A61K 2039/522A61K 9/19A61K 47/26A61K 2039/521C12N 2500/16C12N 2500/32C12N 2500/34C12N 2500/35A61K 47/10A61K 47/183A61P 31/06C12R 2001/32
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Claims

Abstract

The present invention refers to a freeze-dried composition consisting of an isolated microorganism belonging to the Mycobacterium tuberucolosis complex, preferably a M. tuberculos clinical isolate, more preferably M. tuberculosis clinical isolate, characterized in that it comprises a PhoP− phenotype by the inactivation by a genetic deletion of the Rv0757 gene and the deletion of a second gene, Rv2930 (fadD26), that prevents PDIM production (PDIM− phenotype) (the MTBVAC strain), and sucrose and sodium glutamate as stabilizers or excipients. The present invention further refers to the reconstituted composition obtained by adding water, preferably sterilized water for injection, to the freeze-dried composition as well as uses thereof, in particular for use as a prophylactic agent to those at risk of infection with M. tuberulosis or those at risk of developing tuberculosis disease, or as secondary agents for treating infected tuberculosis patients.

Claims

exact text as granted — not AI-modified
1 . An intradermal vaccine composition comprising an isolated  Mycobacterium tuberculosis  bacterium, wherein the  M. tuberculosis  bacterium comprises a PhoP− phenotype from deletion of the Rv0757 gene and a PDIM− phenotype from deletion of the Rv2930 (fadD26) gene, wherein the intradermal vaccine composition comprises at least 1.5×10 4  CFU/0.05 ml of the isolated  M. tuberculosis  bacterium. 
     
     
         2 . (canceled) 
     
     
         3 . The intradermal vaccine composition of  claim 1 , wherein the isolated  M. tuberculosis  bacterium is  M. tuberculosis  MTBVAC strain. 
     
     
         4 . The intradermal vaccine composition of  claim 1 , wherein the intradermal vaccine composition comprises between 1.5×10 4  CFU/0.05 ml and 8.5×10 6  CFU/0.05 ml of the isolated  M. tuberculosis.    
     
     
         5 . The intradermal vaccine composition of  claim 1 , wherein the intradermal vaccine composition comprises between 1.5×10 4  CFU/0.05 ml and 8.5×10 4  CFU/0.05 ml, or between 1.5×10 5  CFU/0.05 ml and 8.5×10 5  CFU/0.05 ml of the isolated  M. tuberculosis  bacterium. 
     
     
         6 . The intradermal vaccine composition of  claim 1 , wherein the intradermal vaccine composition comprises between 1.5×10 6  CFU/0.05 ml and 8.5×10 6  CFU/0.05 ml of the isolated  M. tuberculosis  bacterium. 
     
     
         7 . A method of preventing infection with  M. tuberculosis  complex or tuberculosis disease in a human neonate at risk of infection with  M. tuberculosis  complex or developing tuberculosis disease, the method comprising intradermal administration of the intradermal vaccine composition of  claim 1  to the human neonate. 
     
     
         8 . (canceled) 
     
     
         9 . A method of preventing the development of the clinical symptomatology associated with the active form of the tuberculosis disease caused by  M. tuberculosis  complex in a human neonate at risk of developing tuberculosis disease and suffering from latent tuberculosis infection, the method comprising intradermal administration of the intradermal vaccine composition of  claim 1  to the human neonate. 
     
     
         10 . A method for treating latent and/or active tuberculosis in a neonate, the method comprising intradermal administration of the intradermal vaccine composition of  claim 1  to a neonate as a secondary agent. 
     
     
         11 . A method of vaccinating a human neonate against infection caused by  M. tuberculosis  complex, the method comprising intradermal administration of the intradermal vaccine composition of  claim 1  to a human neonate as a booster vaccine. 
     
     
         12 . A method of preventing an infection other than tuberculosis disease caused by  M. tuberculosis , including infection by non-tuberculous mycobacteria, in a human neonate, the method comprising intradermal administration of the intradermal vaccine composition of  claim 1  to the human neonate. 
     
     
         13 . A An intradermal vaccine composition comprising an isolated  M. tuberculosis  bacterium, wherein the  M. tuberculosis  bacterium comprises a PhoP− phenotype from deletion of the Rv0757 gene and PDIM− phenotype from the deletion of the Rv2930 (fadD26) gene, wherein the intradermal vaccine composition comprises at least 3×10 3  CFU/0.1 ml of the isolated  M. tuberculosis  bacterium. 
     
     
         14 . (canceled) 
     
     
         15 . The intradermal vaccine composition of  claim 13 , wherein the isolated  M. tuberculosis  bacterium is  M. tuberculosis  MT103. 
     
     
         16 . The intradermal vaccine composition of  claim 13 , wherein the isolated  M. tuberculosis  bacterium is  M. tuberculosis  MTBVAC strain. 
     
     
         17 . The intradermal vaccine composition of  claim 13 , wherein the intradermal vaccine composition comprises between 3×10 3  CFU/0.1 ml and 17×10 6  CFU/0.1 ml of the isolated  M. tuberculosis  bacterium. 
     
     
         18 . The intradermal vaccine composition of  claim 13 , wherein the intradermal vaccine composition comprises between 3×10 3  CFU/0.1 ml and 17×10 3  CFU/0.1 ml, or between 3×10 4  CFU/0.1 ml and 17×10 4  CFU/0.1 ml, or between 3×10 5  CFU/0.1 ml and 17×10 5  CFU/0.1 ml, or between 3×10 6  CFU/0.1 ml and 17×10 6  CFU/0.1 ml of the isolated  M. tuberculosis  bacterium. 
     
     
         19 . The intradermal vaccine composition of  claim 13 , wherein the intradermal vaccine composition comprises between 3×10 6  CFU/0.1 ml and 17×10 6  CFU /0.1 ml of the isolated  M. tuberculosis  bacterium. 
     
     
         20 . A method of preventing infections caused by  M. tuberculosis  complex in a non-neonate human at risk of infection with  M. tuberculosis  complex, the method comprising intradermal administration of the intradermal vaccine composition of  claim 13  to the non-neonate human. 
     
     
         21 . The method of  claim 20 , wherein the non-neonate human is a child, adolescent, or adult human. 
     
     
         22 . (canceled) 
     
     
         23 . The intradermal vaccine composition of  claim 1 , wherein the isolated  M. tuberculosis  bacterium is  M. tuberculosis  MT103.

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