AAHI has developed a diagnostic test for visceral leishmaniasis (VL) that spares patients painful and potentially dangerous spleen or bone marrow biopsies and an innovative vaccine that has demonstrated safety and immunogenicity in Phase 1 clinical trials.
AAHI collaborates to provide protection against leishmaniasis.
AAHI scientists were instrumental in development of diagnostic proteins used in simple and rapid blood tests for VL that deliver easy-to-read results in just ten minutes. These proteins enable diagnostic tests that do not require the previously standard painful needle biopsies of the spleen or bone marrow. These diagnostic tests are widely distributed in areas most burdened by VL, including Brazil and India.
AAHI has also created a VL vaccine, combining AAHI’s innovative recombinant protein, LEISH-F3, with AAHI’s immune-stimulating adjuvant formulation GLA-SE. The vaccine demonstrated safety and immunogenicity in Phase 1 clinical trials (NCT01484548 & NCT01751048).
LEISH-F3 was later formulated with AAHI’s SLA-SE adjuvant formulation and tested in comparison to GLA-SE in a Phase 1 clinical trial sponsored by the Bill and Melinda Gates Foundation (NCT02071758). Both vaccine formulations were shown to be safe and to induce the desired immune response.
The bite of the female phlebotomine sandfly, no bigger than the tip of a crayon, can transmit the parasites that cause visceral, cutaneous, and mucosal leishmaniasis (VL, CL, and ML, respectively). VL is 95% fatal if untreated and causes fever, weight loss, and anemia. CL and ML are less severe but can cause serious disabilities. In 2017, the World Health Organization estimated that leishmaniasis caused the loss of over half a million years of health for people primarily living in Brazil, Ethiopia, India, Sudan, Kenya, and Somalia. An estimated 50,000 to 90,000 new cases of VL occur worldwide annually. While insecticide sprays and nets can deter the sandflies, there is no vaccine yet to prevent any of the leishmanial diseases.