The Infectious Disease Research Institute (IDRI) and American Leprosy Missions announced the initiation of a Phase 1 clinical trial in humans for the first leprosy vaccine candidate, LepVax. 

Leprosy (also known as Hansen’s disease) is caused by the Mycobacterium leprae bacteria and results in disfiguration of the skin and mucous membranes as well as incurable nerve damage. Pharmacotherapy for leprosy often causes many adverse effects and requires a long duration of therapy. 

LepVax was designed to treat leprosy and prevent exposed individuals from developing the disease and related disabilities. The vaccine candidate has moved onto Phase 1 clinical testing (clinical trial NCT03302897) in the U.S. based on preclinical study data. The Phase 1 trial will test safety in human volunteers and their immune response to the vaccine. 

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Regarding development, scientists first screened and identified M. leprae proteins that would trigger an effective immune response and then created a fusion of 4 proteins that was combined with IDRI’s immune-stimulating adjuvant (GLA-SE).

Steven Reed, PhD, IDRI President, CEO & Founder, added, “This generation of a vaccine to prevent and possibly treat leprosy is the result of years of research. The development has been complicated by the fact that the organism that causes leprosy cannot be grown in culture in the laboratory. This is a unique example of a vaccine produced by totally synthetic methods.”

Preliminary data from the Phase 1 study is expected to be available in 2018. 

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