Effect of Mycobacterium vaccae (SRL172) immunotherapy on radiographic healing in tuberculosis
METHODS: To assess the effect of M. vaccae immunotherapy on radiographic healing in pulmonary TB, chest X-rays from three randomized placebo-controlled trials of M. vaccae given as a single injection during the first 2 weeks of treatment were interpreted by a single, masked assessor using a standard scheme. Endpoints were the overall degree of radiographic improvement or deterioration and changes in cavitary disease at the end of anti-tuberculosis treatment and follow-up.
RESULTS: Of 1018 patients (478 HIV-infected; 540 HIV-uninfected) with an end of treatment or end of follow-up X-ray analyzed, 496 received M. vaccae and 522 received placebo. There was no difference in radiographic improvement or deterioration or cavitary disease at the end of treatment or follow-up comparing the M. vaccae and placebo groups. Results were similar comparing HIV-infected and HIV-uninfected patients.
CONCLUSION: Adjunctive immunotherapy of drug-susceptible pulmonary TB with M. vaccae during the first 2 weeks of treatment did not improve radiographic responses to treatment or resolution of cavitary disease.
Document Type: Regular Paper
Affiliations: 1: Division of Infectious Diseases, Case Western Reserve University School of Medicine and University Hospitals of Cleveland, Cleveland, Ohio, USA 2: MRC Clinical Trials Unit, London, United Kingdom 3: Lead Programme for TB Research, Medical Research Council, Pretoria, South Africa 4: Chest Clinic, Blackburn Royal Infirmary, Blackburn, United Kingdom; and Postgraduate School of Medicine and Health, University of Central Lancashire, Preston, United Kingdom 5: Makerere University Medical School, Mulago Hospital, Kampala, Uganda 6: University of Zambia–University College London Tuberculosis/HIV Research and Training Project, School of Medicine and the University Teaching Hospital, Lusaka, Zambia 7: Karonga Prevention Study, Karonga, Malawi 8: Intervention Development and Implementation Research, Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland 9: Centre for Infectious Diseases and International Health, Royal Free and University College London Medical School and University College London Hospitals NHS Trust, London, United Kingdom
Publication date: 2004-11-01
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