To study the safety of Brucella melitensis WR201, a live vaccine candidate, we compared the course of infection of this strain with that of virulent 16M in male BALB/c mice. At various times after oral immunization with strains WR201 or 16M, lungs, liver, spleen, testis, epididymis, inguinal and cervical lymph nodes were removed. Tissues were divided for microbiologic culture and histopathological examination. WR201 infection in male BALB/c mice had lower intensity and shorter duration than infection caused by virulent 16M. Pathological examination of testis and epididymis revealed no inflammation following strain WR201 immunization. In contrast, animals given virulent 16M strain had substantial inflammation in infected tissues. These data confirm the marked attenuation of WR201 relative to 16M. In addition, these studies suggest that male mice may be useful to assess the safety of live, attenuated Brucella vaccine candidates.