Intercell starts pivotal Phase II/III study for JE vaccine in India
Vienna/Hyderabad – Austria vaccine specialist Intercell AG and its Indian manufacturing partner Biological E. Ltd. have started enrolment of a Phase II/III study in children of 1-3 years of age for Intercell’s preventive vaccine against Japanese Encephalitis (JE). The vaccine, which is manufactured in India by Biological E. has been already safety tested on 20 adults, is based on Intercell's technology. This randomized and controlled study will be the first pivotal Phase II/III study in an endemic region towards licensure of the paediatric JE vaccine and aims at investigating safety and immunogenicity compared to a licensed competitor Japanese Encephalitis vaccine in healthy children. Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travellers and military personnel in Europe, the USA and Australia, the development of a vaccine to protect children in endemic areas from Japanese Encephalitis has been a major goal of the company. Japanese Encephalitis (JE) is a deadly infectious disease found mainly in Asia. Approximately 30,000 to 50,000 cases of JE are reported in Asia each year, and the actual number of cases is likely much higher due to under-reporting in rural areas. JE is fatal in approximately 30 percent of those who show symptoms and leaves half of survivors with permanent brain damage. In 2005, Intercell and Biological E. signed a contract for the development, manufacturing, marketing and distribution in India and the Indian subcontinent of Intercell's Japanese Encephalitis vaccine. The vaccine's further regulatory approval route for other Asian territories is expected through the World Health Organization – Novartis will be responsible for the marketing and distribution in these regions.