Infectious Disease Research Institute (IDRI) and American Leprosy Missions in the US have launched a Phase I clinical trial to evaluate a vaccine candidate, LepVax, specifically developed for leprosy.
The disease’s existing drug therapy, which needs to be taken for a long duration, is reported to have various side effects and often given too late, resulting in irreversible permanent damage due to the infection.
IDRI scientists have developed the investigational vaccine candidate in collaboration with national and international organisations such as the National Hansen’s Disease Programme and the National Institute of Allergy and Infectious Diseases (NIAID).
The vaccine is being developed for aiding leprosy treatment as well as to prevent development of the infection and associated disabilities in exposed people.
Designed to assess the safety of LepVax and body’s immune response to the vaccine, the Phase I trial is based on findings from preclinical studies.
IDRI president, CEO and founder Steven Reed said: “While previous attempts have used vaccines primarily developed for other diseases, this is the first totally defined vaccine candidate developed specifically for leprosy, using the latest technologies and offering no less than those exposed to leprosy deserve.
“This vaccine represents a unique accomplishment, requiring the most advanced technologies in molecular biology and immunology, and American Leprosy Missions has been there from the beginning.”
For the development of LepVax, the researchers identified and fused four immune response-inducing Mycobacterium leprae proteins with IDRI’s immune-stimulating adjuvant, GLA-SE.
It is expected that the vaccine could trigger responses after infection, thereby preventing the development of the disease in individuals who are already infected with the bacterium.
LepVax is part of an overall initiative to detect, prevent and treat leprosy.