title: Randomized controlled trial of Mycobacterium vaccae immunotherapy in non-human immunodeficiency virus-infected ugandan adults with newly diagnosed pulmonary tuberculosis. The Uganda-Case Western Reserve University Research Collaboration.
abstract: 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. 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 (P=.01) but was comparable at 2 months and thereafter. Patients receiving M. vaccae had greater improvement on chest radiography at 6 months (91% vs. 77% for placebo recipients; P=.04) and 12 months (94% vs. 80%; P=.04) after initiation of tuberculosis treatment. These data provide evidence of an early increase in sputum culture conversion and greater radiographic improvement among patients who received M. vaccae. Further studies are warranted.
authors.affiliation: Department of Medicine, Division of Infectious Diseases, Case Western Reserve University, Tuberculosis Research Unit, Cleveland, OH 44106-4984, USA. jlj@po.cwru.edu
authors.forename: J L
authors.initials: JL
authors.lastname: Johnson
authors.forename: R M
authors.initials: RM
authors.lastname: Kamya
authors.forename: A
authors.initials: A
authors.lastname: Okwera
authors.forename: A M
authors.initials: AM
authors.lastname: Loughlin
authors.forename: S
authors.initials: S
authors.lastname: Nyole
authors.forename: D L
authors.initials: DL
authors.lastname: Hom
authors.forename: R S
authors.initials: RS
authors.lastname: Wallis
authors.forename: C S
authors.initials: CS
authors.lastname: Hirsch
authors.forename: K
authors.initials: K
authors.lastname: Wolski
authors.forename: J
authors.initials: J
authors.lastname: Foulds
authors.forename: R D
authors.initials: RD
authors.lastname: Mugerwa
authors.forename: J J
authors.initials: JJ
authors.lastname: Ellner
mesh_terms: D000328:Adult; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D009161:Mycobacterium / Q000145:classification / Q000276:immunology*; D013902:Radiography, Thoracic; D013183:Sputum / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000628:therapy*; D014454:Uganda; D015164:Vaccines, Inactivated
chemical_list: D015164:Vaccines, Inactivated