DEVELOPMENT OF A DNA VACCINE FOR LEISHMANIASIS
Summary:
This project is focused on preclinical development of a safe and efficient prophylactic and therapeutic DNA vaccine ready for clinical trials against different forms of leishmaniasis. The vaccine will be based on the Minimalistic Immunogenically Defined Gene Expression (MIDGE) vector developed for efficient induction of T-cellular immune responses and, if required, adjuvanted with Double Stem Loop Immunomodulator (dSLIM). Based on preset criteria, we will select 3-5 known protective antigens from a predefined shortlist and incorporate their genes into MIDGE vectors. To complete the preclinical requirements, efficacy and safety studies will be conducted for prophylactic as well as therapeutic indications. The prototype vaccine will be produced under GMP conditions. While all this is being done, we will identify and prepare sites to conduct clinical trials at ICH-GCP standards against different forms of leishmaniasis. This includes training in preclinical and clinical development, and establishing all required components and infrastructure to conduct trials at the highest international standard. The consortium includes partners with extensive experiences in Leishmania research and vaccine development in India (IICB & RMRI), Tunisia (Inst. Pasteur, Tunis), Israel (HUJI), Germany (Charite & Mologen AG) and United Kingdom (LSHTM).
Results:
These will include: (a) construction of MIDGE-vectors with selected Leishmania antigens, (b) production under GMP conditions, (c) demonstration of the safety and efficacy of candidates in animal models, and (d) preparation for clinical studies.
Potential applications:
Protection against different forms of leishmaniasis and therapeutic with or without chemotherapy.
