- Developed a diagnostic test for visceral leishmaniasis (VL) that spares patients painful and potentially dangerous spleen or bone marrow biopsies.
- Developed an innovative cutaneous leishmaniasis (CL) vaccine candidate that has demonstrated safety and immunogenicity in Phase 1 clinical trials.
VL is 95% fatal if untreated and causes fever, weight loss, and anemia.
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, VL, and ML, respectively).
CL causes skin lesions, mostly ulcers, that lead to permanent scars and serious disability, including stigmitization and mental health problems.
ML leads to partial, if not complete distruction of the mucosa in the nose, mouth, and throat.
A TREATABLE DISEASE
Treatment for local disease is pentavalent antimonials, paramomycin, cryotherapy, and thermotherapy. Systemic treatment includes an expensive cocktail of drugs.
Insecticide sprays and nets can deter the sandflies, but there is no protection against the disease otherwise and attempts to control sandfly behavior are ineffective.
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.
Leishmaniasis is associated with poor housing, population discplacement, and lack of financial resources, significantly impacting low-and middle-income countries. There remains little financial backing for developing an accessible solution for the people most burdened by the disease.
Lack of waste management creates resting and breeding sites for sandflies.
Insufficient protein, iron, vitamin A and zinc increases the risk of infection from a bite, will turn into a full-blown disease
Environmental and climate changes affect sandfly behaviour through changes in urbanization, deforestation, temperature, and rainfall.
Brazil, East Africa, India are most burdened by VL. An estimated 25-45% of cases are reported to the World Health Organization.
Central and South America, the Mediterranean basin, the Middle East, and central Asia are where 95% of CL cases occur.
Over 90% of ML cases occur in Bolivia, Brazil, Ethiopia, and Peru.
A NEW DIAGNOSTIC
Standard diagnostic tests require painful needle biopsies of the spleen or bone marrow.
AAHI scientists were instrumental in the development of diagnostic proteins used in simple and rapid blood tests for VL that delivery easy-to-read results in just ten minutes.
These diagnostic tests are widely distributed in areas most burdened by VL, including Brazil and India.
AAHI combines its recombinant protein, LEISH-F2, with its GLA-SE adjuvant formulation. The vaccine candidate has been clinically evaluated in the United States, Brazil, Peru, Colombia, India, and Sudan in seven different clinical trials, demonstrating it is safe and well-tolerated in humans.
AAHI combines its innovative recombinant protein, LEISH-F3, with its GLA-SE adjuvant formulation. 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.