About the vaccine

The FP7 call provides the opportunity for us to bring together experts in leishmaniasis covering clinical immunology, molecular biology, clinical trials, vaccine development and capacity strengthening with a European SME (MOLOGEN AG) having expertise in GMP, GLP, preclinical and clinical development with a new technology, the Minimalistic Immunogenetically Defined Gene Expression (MIDGE) vector, targeted for Th1 stimulation, potentially adjuvanted with the Double Stem Loop Immunomodulator (dSLIM) (http://www.mologen.com ).  MIDGE consists of a linear, double stranded DNA molecule, with the ends covalently closed by ligated hairpin-shaped DNA oligonucleotides.

A Product Profile (PP) was developed for the vaccine and the need and feasibility of implementation in the target foci.  A set of criteria was established by the consortium for selection of candidate antigens to be incorporated in LEISHDNAVAX.  These criteria are that antigens must be: a) Conserved amongst many Leishmania species; b) Abundant in amastigotes; c) Present on infected macrophages; d) Recognized by effector T cells; e) Protective in in vivo models, f) Present in recent isolates from target foci, g) Contain multitude of T cell epitopes for target populations (selection will be done by matching the immunogenicity of the antigen and the HLA profile of target population);  d) Have the desired characteristics for incorporation into the MIDGE vector to be stable and able to be expressed.  Using these criteria and all available data on known protective antigens published so far or discovered by our partners, three candidates were identified and prioritised to be included and some others to be further studied for selection of one or two more antigens.