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

Abstract

Adjunctive immunotherapy with heat-killed Mycobacterium vaccae was studied in a ran-domized, placebo-controlled trial of 120 non±human immunode®ciency virus±infected adults with newly diagnosed pulmonary tuberculosis. Patients were randomized to a single dose of M. vaccae or placebo 1 week after beginning 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 tuberculosis treatment was 35 % in the M. vaccae group and only 14 % in the placebo group ( ) but was comparable at 2 months and thereafter. Patients receiving M. vaccae hadP =.01 greater improvement on chest radiography at 6 months (91 % vs. 77 % for placebo recipients;) and 12 months (94 % vs. 80%; ) after initiation of tuberculosis treatment. TheseP =.04 P =.04 data provide evidence of an early increase in sputum culture conversion and greater radio-graphic improvement among patients who received M. vaccae. Further studies are warranted. Mycobacterium vaccae is a rapidly growing environmental mycobacterium originally isolated in Uganda [1] that has low pathogenicity for humans [2]. Heat-killed preparations of M. vaccae have been studied as an adjunct to standard antituber-culosis drug therapy for 11 decade. M. vaccae expresses anti