Leprosy vaccine: influence of dissolved oxygen levels on growth of a candidate strain (Mycobacterium w), and storage stability of the vaccine

The growth of Mycobacterium w, a candidate strain for leprosy vaccine in submerged culture, was inhibited by the presence of over 40% oxygen saturation in the medium. Intracellular levels of superoxide dismutase and catalase were very low in the beginning. However, under controlled oxygenation, these levels increased with time. The augmentations of these antioxidant enzymes were associated with the elevated oxygen consumption by the culture. By maintaining the oxygen level below 20% during 6-day culture, it was possible to grow Mycobacterium w in five production batches up to a cell density of 3.7 +/- 0.70 x 10(9) bacilli ml-1. The shelf life of the vaccine produced in different batches was more than 2 years, both at 4 degrees C and at 26 degrees C. This provides a cost-effective, unit culture technology for the production of this candidate leprosy vaccine from a nonpathogenic organism, which will facilitate the widespread use of the vaccine.