Immunotherapy with Oral, Heat-Killed, Mycobacterium Vaccae in Patients with Moderate to Advanced Pulmonary Tuberculosis

Abstract

A research investigation to evaluate the potential of an oral preparation of Mycobacterium vaccae SRL172 (NCTC 11659) as an immunotherapeutic has been carried out in ten patients with moderate to advanced pulmonary tuberculosis at Carrasco Hospital, Argentina. Comparison was made between oral and injected M.vaccae sharing a mutual control group. Clinical, bacteriological, hematological, radiological and immunological assessments all showed comparable benefits for both injected and oral treatment over those achieved with chemotherapy alone. The only significant difference between results of injected and oral M.vaccae was the failure of the latter to reduce TNF-α production by cultured mononuclear cells. A more intensive regime for the oral preparation was used, which as an addition to the directly observed therapy, short-course, treatment should improve results in both drug susceptible and drug-resistant cases. A Phase II Good Clinical Practice trial is now required.

KEYWORDS::

• immunological investigation
• immunotherapy
• Mycobacterium vaccae
• oral capsule
• pulmonary tuberculosis

Financial & competing interests disclosure

Supplies of SRL172, from which the oral formulation was prepared, and some financial support for the purchase of reagents was kindly provided by SR Pharma plc, London, UK. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

Supplies of SRL172, from which the oral formulation was prepared, and some financial support for the purchase of reagents was kindly provided by SR Pharma plc, London, UK. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.