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. NLM AIDSLINE Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

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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.

J Infect Dis. 2000 Apr;181(4):1304-12. Unique Identifier : AIDSLINE MED/20227752
Johnson JL; Kamya RM; Okwera A; Loughlin AM; Nyole S; Hom DL; Wallis RS; Hirsch CS; Wolski K; Foulds J; Mugerwa RD; Ellner JJ; Department of Medicine, Division of Infectious Diseases, Case; Western Reserve University, Tuberculosis Research Unit,; Cleveland, OH 44106-4984, USA. jlj@po.cwru.edu


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.


Keywords: CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL Adult Female Health Status Indicators Human Male Mycobacterium/CLASSIFICATION/*IMMUNOLOGY Radiography, Thoracic Sputum/MICROBIOLOGY Support, U.S. Gov't, P.H.S. Tuberculosis, Pulmonary/*THERAPY Uganda Vaccines, Inactivated

KWDclinicaltrialjournalarticlerandomizedcontrolledtrialadultfemalehealthstatusindicatorshumanmalemycobacterium/classification/KWDimmunologyradiography,thoracicsputum/microbiologysupport,uKWDsKWDgov't,pKWDhKWDsKWDtuberculosis,pulmonary/KWDtherapyugandavaccines,inactivated
000830
A0080953


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