We will provide a new vaccine to prevent TB. [Solution] The present invention relates to a freeze-dried composition comprising a
Mycobacterium tuberculosis complex, preferably a clinical isolate of M.
tuberculosis, more preferably a clinical isolate of M.
tuberculosis (MTBVAC strain), characterized by comprising a PhoP-
phenotype due to inactivation by genetic deletion of the Rv0757
gene and a PDIM-
phenotype due to deletion of a second
gene Rv2930 (fadD26) that inhibits PDIM production, and
sucrose and
sodium glutamate as stabilizers or excipients. Furthermore, the present invention relates to a reconstituted composition obtained by adding water, preferably
sterile water for injection, to the freeze-dried composition. The present invention relates to the composition to be used as a prophylactic agent for people at
risk of infection with M. tuberculosis, or as a secondary
drug for treating infected tuberculosis patients.