Every year, an estimated quarter million people worldwide – mostly in Africa, Asia and Latin America – are diagnosed with leprosy, a cruel disease that leaves its victims maimed, crippled, disfigured and blind, often with terrible quality of life.
Leprosy, an ailment most people associate with biblical times, is a chronic infectious disease caused by the bacterium Mycobacterium leprae – a bacterium related to the organism that causes tuberculosis. It was reported in 130 countries in the past year and is prevalent in countries throughout Africa, Asia and South America.
Symptoms include progressive and permanent damage to the skin, nerves, limbs and eyes that can take several years to appear, making the disease hard to diagnose at an early stage. Infection and damage of the peripheral nerves leads to numbness or loss of sensitivity to touch, muscle weakness and atrophy. Nearly 250,000 new cases of leprosy are diagnosed every year, and many more go undetected.
Despite the availability of drug treatment, the stigma attached to leprosy has often caused those who contract the disease to be shunned by family, friends and society.
Seeking a better solution, IDRI decided to attack leprosy in two different ways. First, by developing a fast, easy diagnostic test (the current method is inadequate, by clinical and/or microscopic assessment); and, second, by developing a vaccine that can immunize people against leprosy, while also providing treatment to those who have been exposed to the disease but are not yet showing symptoms.
IDRI has developed a rapid diagnostic test for leprosy infection, offering new hope for early diagnosis and treatment. Using just a single drop of blood and showing results within a few minutes, the test is currently registered for use in Brazil.
While IDRI’s work in diagnostics can aid in early detection of leprosy, scientists at the organization are also focused on developing a vaccine. Although there are drugs to treat leprosy, there hasn’t been a focus on prevention.
IDRI scientists have developed a promising leprosy vaccine candidate designed to help treat leprosy and prevent exposed individuals from developing disease and the resulting disabilities. Based on data generated in preclinical studies, the vaccine candidate, called LepVax, has progressed to Phase I clinical testing in the United States, the first stage of safety testing in human volunteers. The clinical trial is focused on safety, as well as evaluating the immune response to the vaccine.
Once the three components are in place – a test to diagnose, drugs to treat and a vaccine to prevent – the tools to bring an end to this devastating disease will finally be in place.
Produced world’s largest collection of leprosy antigens and screened them for promising prophylactic, therapeutic and diagnostic potential.
Designed the first leprosy vaccine candidate.
Developed a T-cell based test to determine which of the people shown to be infected (using IDRI’s already registered antibody test) are likely to self-cure or otherwise develop specific types of active disease. This ensures appropriate case management and therapeutic treatment, as well as prevents nerve damage and continued transmission of M. Leprae.
Licensed technology for the development and commercialization of an antibody diagnostic to detect infection of M. Leprae, the causative agent of leprosy, in advance of clinical symptoms. This test is approved and registered in Brazil.
Final development, approval and distribution of IDRI’s new diagnostic for worldwide distribution.
Conduct clinical trials of IDRI’s leprosy vaccine candidate to show its effectiveness and obtain regulatory distribution.
Launch a leprosy elimination campaign – initially through early diagnosis and treatment, and later with the addition of an effective vaccine.