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. Patients were randomized to a single dose of M. vaccae or placebo 1 week after beg...

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Bibliographic Details
Published in:The Journal of infectious diseases 2000-04, Vol.181 (4), p.1304-1312
Main Authors: Johnson, John L., Kamya, R. Moses, Okwera, Alphonse, Loughlin, Anita M., Nyole, Sam, Hom, David L., Wallis, Robert S., Hirsch, Christina S., Wolski, Kathy, Foulds, John, Mugerwa, Roy D., Ellner, Jerrold J.
Format: Article
Language:English
Subjects:
Bacterial diseases
Biological and medical sciences
Blood
Chemotherapy
Cytokines
Human bacterial diseases
Immunotherapy
Infectious diseases
Major Article
Medical sciences
Mycobacterium
Mycobacterium tuberculosis
Mycobacterium vaccae
Placebos
Pulmonary tuberculosis
Sputum
Tuberculosis
Tuberculosis and atypical mycobacterial infections
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Summary: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.
ISSN:0022-1899
1537-6613
DOI:10.1086/315393