The World Health Organization 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 1 billion people worldwide can be effectively controlled and, in many cases, eliminated or even eradicated. Leishmaniasis caused by Leishmania spp is one such example and poses a grave health risk to an estimated 350 million people. Between 200,000 and 400,000 cases of visceral leishmaniasis (VL) are reported annually from endemic areas of the Mediterranean, the Middle East, Latin America, Asia and Africa.
What we are doing
In our approach, we mimic a natural infection cycle of Leishmania, by introducing the recombinant protein LJL143 from the sand fly saliva and a polyprotein fusion Leish-F3+ consisting of 3 Leishmania antigens. These components will be formulated with a strong TLR4 agonist, GLA-SE already tested in humans, to enhance and modulate the immune response to TH1 type immunity. This innovative vaccine will be produced at PAI Life Sciences. Vaccine-generated immune responses that exploit the host-vector-parasite interface and are targeted to antigens of Leishmania parasites and phlebotomine sand fly vector could ultimately result in lower transmission. Here we propose to initiate process development on a parasite (Leish-F3+) and a sand fly vector (LJL143) antigen with the goal of developing cGMP compliant production processes followed by immunogenicity, potency and efficacy testing at IDRI to ultimately enable FDA regulated, human clinical trials.