Immunological basis for the introduction of immunotherapy with Mycobacterium vaccae into the routine treatment of TB.

An account is given of the immunological investigations carried out in Rosario (Argentina) to identify suitable methods for the assessment of the efficacy of immunotherapy for TB. Some of these were then applied to three small studies: one of a single injected dose of heat-killed, borate-buffered Mycobacterium vaccae administered early in treatment, another of three such doses administered at monthly intervals from the start of treatment, and the third of ten oral doses at frequent intervals throughout short-course chemotherapy. All three displayed better clearance of bacilli from the sputum, faster improvement in clinical symptoms, better radiological resolution of lesions and a return of most immunological parameters towards those of healthy persons. In principle, the immune change achieved is an increase in Th1 mechanisms, notably IL-2 and -12 with downregulation of the tissue damaging aspects of Th2. As an addition to chemotherapy for drug-susceptible or drug-resistant TB, with or without concomitant HIV infection, this immunotherapy offers a safe and effective improvement.