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Title: Construction and Characterization of the Mycobacterium tuberculosis sigE fadD26 Unmarked Double Mutant as a Vaccine Candidate
Authors: Hernandez-Pando, Rogelio
Shin, Sung Jae
Clark, Simon
Casonato, Stefano 
Becerril-Zambrano, Martin
Kim, Hongmin
Boldrin, Francesca 
Mata-Espinoza, Dulce
Provvedi, Roberta 
Arbues, Ainhoa
Marquina-Castillo, Brenda
Cioetto Mazzabò, Laura
Barrios-Payan, Jorge
Martin, Carlos
Cho, Sang-Nae
Williams, Ann
Manganelli, Riccardo 
Keywords: BCG;SigE;sigma factor;tuberculosis;vaccine
Mesh headings: Ligases;Mycobacterium tuberculosis;Sigma Factor;Tuberculosis Vaccines;Tuberculosis, Pulmonary
Secondary Mesh headings: Animals;Bacterial Proteins;Disease Models, Animal;Guinea Pigs;Mice;Vaccines, Attenuated;Virulence
Issue Date: 2019
Journal: Infection and immunity 
Despite the great increase in the understanding of the biology and pathogenesis of Mycobacterium tuberculosis achieved by the scientific community in recent decades, tuberculosis (TB) still represents one of the major threats to global human health. The only available vaccine (Mycobacterium bovis BCG) protects children from disseminated forms of TB but does not effectively protect adults from the respiratory form of the disease, making the development of new and more-efficacious vaccines against the pulmonary forms of TB a major goal for the improvement of global health. Among the different strategies being developed to reach this goal is the construction of attenuated strains more efficacious and safer than BCG. We recently showed that a sigE mutant of M. tuberculosis was more attenuated and more efficacious than BCG in a mouse model of infection. In this paper, we describe the construction and characterization of an M. tuberculosissigE fadD26 unmarked double mutant fulfilling the criteria of the Geneva Consensus for entering human clinical trials. The data presented suggest that this mutant is even more attenuated and slightly more efficacious than the previous sigE mutant in different mouse models of infection and is equivalent to BCG in a guinea pig model of infection.
ISSN: 00199567
DOI: 10.1128/IAI.00496-19
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