INTERCELL STARTS PHASE III TRIALS OF JAPANESE ENCEPHALITIS VACCINE

Intercell has announced the start of global multicenter Phase III clinical trials of its Japanese Encephalitis vaccine, IC51. Japanese Encephalitis (JE) is a mosquito-borne flaviviral infection and the leading cause of viral encephalitis in Asia. The infection is a major health problem throughout Asia, where 3 billion people live in JE-endemic areas.

The global Phase III program consists of a series of immunogenicity and safety trials and will enroll more than 4,900 subjects. Furthermore, a one-time vaccination schedule is included in the program.

The immunogenicity studies will take place in Austria, Germany and the U.S. The study is designed to demonstrate noninferiority of the Intercell vaccine compared to JE-VAX. JE-VAX is the only Japanese Encephalitis vaccine approved in the U.S. The trial will compare the ability of IC51 and JE-VAX to elicit seroconversion. So far, about 300 subjects have already been enrolled for the program.