Randomized controlled trial of Mycobacterium vaccae immunotherapy in non-human immunodeficiency virus-infected ugandan adults with newly diagnosed pulmonary tuberculosis

Adjunctive immunotherapy with heat-killed Mycobacterium vaccae was studied in a randomized, placebo-controlled trial of 120 non-human immunodeficiency virus-infected adults with newly diagnosed pulmonary tuberculosis. Patient s were randomized to a single dose of M. vaccae or placebo 1 week after beg inning chemotherapy and were followed up for 1 year. M. vaccae was safe and well tolerated. The rate of sputum culture conversion after 1 month of tub erculosis treatment was 35% in the M. vaccae group and only 14% in the plac ebo group (P = .01) but was comparable at 2 months and thereafter. Patients receiving M. vaccae had greater improvement on chest radiography at 6 mont hs (91% vs. 77% for placebo recipients; P = .04) and 12 months (94% vs. 80% ; P = .04) after initiation of tuberculosis treatment. These data provide e vidence of an early increase in sputum culture conversion and greater radio graphic improvement among patients who received M. vaccae. Further studies are warranted.