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Respir Med. 1995 Mar;89(3):199-207.

Immunotherapy with Mycobacterium vaccae as an addition to chemotherapy for the treatment of pulmonary tuberculosis under difficult conditions in Africa.

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  • 1Department of Medical Microbiology, University College London Medical School.


A study to assess the impact of immunotherapy with Mycobacterium vaccae on the treatment of pulmonary tuberculosis was conducted under existing conditions in Kano, a large city in Northern Nigeria. Whilst it did not quite meet all the criteria of a well-controlled randomized or double-blind trial, the study produced results suggestive of a successful intervention. Immunotherapy with M. vaccae had a beneficial influence on clinical recovery and survival, whether given after 1, 2 or 3 weeks of chemotherapy, according to an assessment made 10-14 months after treatment. Approximately 3 weeks (19.8 days) after the onset of chemotherapy (SHRZ), 73% of the patients who received immunotherapy and 19% of those who received placebo (chemotherapy alone) had become sputum negative by microscopy for acid-fast bacilli (AFB). Similarly, a mean fall in erythrocyte sedimentation rate (ESR) of 25.4 +/- 2.50 mm and 4.0 +/- 2.29 mm was observed in the immunotherapy and placebo recipients respectively, at the same time of assessment. When weight was assessed in the two groups, it was observed that 3 weeks after starting chemotherapy, the recipients of immunotherapy had a mean weight gain of 2.90 +/- 0.24 kg whilst placebo recipients had a mean weight gain of only 0.55 +/- 0.17 kg. These parameters were re-evaluated, 10-14 months later. They showed that 11% of the recipients of the active intervention and 84.6% of placebo recipients still had demonstrable AFB in their sputum. The mean weight gain had increased to 7.91 +/- 1.03 kg and 2.04 +/- 0.94 kg in the immunotherapy and placebo recipients respectively.(ABSTRACT TRUNCATED AT 250 WORDS)


During December 1990-April 1991 in northern Nigeria, investigators randomly assigned 180 patients who presented at the Infectious Diseases Hospital in Kano with symptoms of pulmonary tuberculosis (TB) and acid-fast bacilli (AFB) in unconcentrated sputum to receive either an intradermal injection of killed Mycobacterium vaccae or a saline injection (i.e., placebo) after one, two, or three weeks of chemotherapy (streptomycin, rifampicin, isoniazid, and pyrazinamide). The patients were blinded to the intervention they received. The investigators followed the patients for 10-14 months. They wanted to determine the effect of immunotherapy with M. vaccae on the treatment of pulmonary TB. At first follow-up (19.8 days for immunotherapy and 20 days for placebo group), the immunotherapy group was significantly more likely than the placebo group to have sputum negative for AFB (73% vs. 19%; p 0.00001). The erythrocyte sedimentation rate decreased by a mean of 25.4 mm in the immunotherapy group as compared by 4 mm in the placebo group (p 0.001). Patients in the immunotherapy group gained much more weight between onset of chemotherapy and 3 weeks after onset than did those in the placebo group (2.9 vs. 0.55 kg; p 0.001). 10-14 months after onset of chemotherapy, the immunotherapy group was less likely than the placebo group to have AFB in their sputum (33% vs. 84.6%; p 0.00002). Immunotherapy patients had gained more weight than placebo patients (7.91 vs. 2.04 kg; p 0.003). None of the immunotherapy patients had died, while 40% of the placebo patients who could be traced had died (p 0.00001). These findings suggest that immunotherapy had beneficial effects within the first 2 weeks after its injection and that a second dose may benefit patients with a persisting sputum positivity beyond the first 2 weeks. In conclusion, immunotherapy should be administered as soon as possible.

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