Intercells investigational vaccine against Japanese Encephalitis shows excellent safety and immunogenicity in Phase II trials
Japanese Encephalitis (JE) Vaccine meets primary endpoints in Phase II trials in children
Intercell AG and its partner Biological E. Ltd. announced the analysis of Phase II data for its investigational pediatric vaccine against Japanese encephalitis. The randomized and controlled study shows an excellent safety and immunogenicity profile amongst children in endemic areas. The study which started in 2007 enrolled 60 healthy children at the age of one to three years.
The seroconversion rate of the test vaccine (given in two doses at days 0 and 28) in the IC513mcg dose group (half adult dose) was 96 % and thus comparable to seroconversion rates observed in adults in former pivotal Phase III clinical trials. Also the geometric mean titers (GMT of about 200) observed at day 56 after the first vaccination for recipients in the half adult dose group were in a similar range to the ones recorded in the pivotal Phase III trials for adults. The safety profiles of IC51 in children were very favorable and are fully in line with the data obtained from the broad Phase III safety studies in adults.
In summary the data suggest that IC51 in young children (one to three years of age) has a comparable excellent immunogenicity and safety profile as in adults even if only half of the adult dose is applied. This allows Intercell and its partner Biological E. to enter into late stage development towards the licensure of the vaccine for the use in children in India and other parts of South East Asia. Start of Phase III clinical trials in India are planned for end 2008/early 2009.
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