Effect of Mycobacterium vaccae (SRL172) immunotherapy on radiographic healing in tuberculosis
Abstract:OBJECTIVE: Controlled trials have failed to show an effect of Mycobacterium vaccae immunotherapy on treatment outcome and mortality in patients with tuberculosis (TB); however, several studies have suggested improvement in radiographic clearing and resolution of cavitary disease.
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: November 1, 2004
The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.
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