Tuberculosis is the most widespread and lethal infectious disease affe
cting humans. Immunization of mice with plasmid DNA constructs encodin
g one of the secreted components of Mycobacterium tuberculosis, antige
n 85 (Ag85), induced substantial humoral and cell-mediated immune resp
onses and conferred significant protection against challenge with live
M. tuberculosis and M. bovis bacille Calmette-Guerin (BCG). These res
ults indicate that immunization with DNA encoding a mycobacterial anti
gen provides an efficient and simple method for generating protective
immunity and that this technique may be useful for defining the protec
tive antigens of M. tuberculosis, leading to the development of a more
effective vaccine.