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Leishmaniasis is a major health problem in some endemic areas and yet, no vaccine is available against any form of the disease. Historically, leishmanization (LZ) which is an inoculation of individual with live  Leishmania , is the most effective control measure at least against cutaneous leishmaniasis (CL). Due to various reasons, LZ is not used today. Several live attenuated  Leishmania  have been developed but their use is limited. Previously, we developed a transgenic strain of  L. major  that harbors two suicide genes  tk  and  cd  genes ( lmtkcd +/+  ) for use as a challenge strain in vaccine studies. These genes render the parasite susceptible to  Ganciclovir  (GCV) and 5-flurocytosine (5-FC). The dual drug sensitive strain of  L. major  was developed using gene targeting technology using a modified Herpes Simplex Virus thymidine kinase gene ( hsv-tk ) sensitive to Ganciclovir antibiotic and  Saccharomyces cerevisae  cytosine deaminase gene ( cd  sensitive to 5-flurocytosine) that were stably introduced into  L. major  chromosome. BALB/c mice inoculated with  lmtkcd +/+   developed lesions which upon treatment with GCV and 5-FC completely healed. In the current study, the transgenic  lmtkcd +/+  strain was assessed as a live vaccine model to determine the time necessary to develop a protective immune response. C57BL/6 mice were inoculated with the transgenic  lmtkcd +/+  strain, and treated at the time of inoculation (day0) or at day 8 after inoculation. Immunized animals were challenged with wild-type  L. major , and complete protection was induced in mice that were treated at day 8. The results show that in contrast to leishmanization, in group of mice inoculated with a dual sensitive  L. major  development and persistence of lesion is not necessary to induce Th1 response and protection.

A Dual Drug Sensitive L. major Induces Protection without Lesion in C57BL/6 Mice