Clinical Studies on a Multivalent Vaccine for Huma.. (MuLeVaClin)
Clinical Studies on a Multivalent Vaccine for Human Visceral Leishmaniasis
Date du début: 1 nov. 2013,
Date de fin: 31 oct. 2018
The World Health Organisation in its report on Neglected Tropical Diseases has stated that there is overwhelming evidence to show that the burden caused by many of the 17 diseases that affect more than 1billion people worldwide can be effectively controlled and, in many cases, eliminated or even eradicated. Leishmaniasis caused by Leishmania spp is one of them and poses a grave health risk to an estimated 350 million people across the world. Among the three clinical patterns of Leishmaniasis (cutaneous, mucocutaneous, and visceral), Visceral Leishmaniasis (VL), also known as kala azar is the most severe in terms of symptoms and clinical complications. If left untreated, the disease can have a fatality rate as high as 100%.Only few drugs are available in the foreseeable future for treating patients from this disease. The development of a human vaccine against Leishmania is an achievable goal.In endemic areas, the majority of infected persons do not develop clinical symptoms and past infection leads to robust immunity against reinfection. In our approach, we mimic a natural infection cycle of Leishmania, by introducing the recombinant protein LJM11 from the sand fly saliva and two other components of Leishmania infantum based on well proven effective recombinant proteins from Leishmania: KMP11 and a recombinant fusion protein SMT-NH. These components will be formulated with a strong TLR4 agonist, already tested in humans, to enhance and modulate the immune response. This innovative vaccine will be tested at the Swiss Tropical and Public Health Institute, which already has experience in conducting clinical trials with Leishmania vaccines. The phase I/II clinical trial will be immunologically monitored by experienced institutions from EU and US. A European SME would have most of the benefits of this project: it would allow to further develop a vaccine against this neglected disease and increase the possibility to out-license this vaccine for commercialization.
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