Leishmaniasis was declared at the 60th WHO Assembly (2007) one of the world’s most neglected diseases. Leishmaniasis affects largely the poorest of the poor, mainly in developing countries as India, Bangladesh, Sudan, Ethiopia and Latin America. Existing treatments have severe drawbacks: side effects, increasing drug-resistance, high cost and long term treatment. Parasite control policies are shown to be insufficient, impractical, or difficult to sustain. To date there is no effective vaccine against human leishmaniasis.
Eight collaborating institutions have formed a consortium to develop a multivalent vaccine for human visceral leishmaniasis (MuLeVaClin). This project started with the production of recombinant proteins and adjuvants and it will end with clinical evaluation.
The developed vaccine candidate consists of highly conserved leishmania proteins together with a salivary molecule of the sand fly. As pure, recombined proteins often induce weak T cell responses, the vaccine is loaded to influenza virosomes. These virosomes are potent delivery vehicles targeting the antigen presenting dendritic cells.
In this phase I/II study, healthy volunteers in Switzerland will participate. The participants will be randomly enrolled into five arms. This will allow comparing different doses of the candidate vaccine combined with or without adjuvant. The purpose is the investigation of safety and tolerability of adjuvanted and non-adjuvanted vaccine formulation. In addition, efficiency of immune response induction will be examined.