Acambis completes enrollment of Phase 3 JE vaccine trials ahead of schedule
Acambis plc announced that it has completed enrolment into two pivotal Phase 3 trials of its investigational vaccine against Japanese encephalitis (JE), ChimeriVax-JE, ahead of schedule. With this milestone met, Acambis remains on track for preparing the ChimeriVax-JE licence applications for submission in India and Australia in 2007.
More than 2,800 healthy adults are involved in the two Phase 3 trials, which are designed to provide comprehensive safety data and to evaluate the neutralising antibody responses of a single-dose of ChimeriVax-JE compared to JE-VAX®, a licensed three-dose JE vaccine. The multi-centre trials were initiated in November 2005 and are being conducted in Australia and the US.
Acambis' Chief Executive Officer Gordon Cameron commented: "We are making rapid progress towards our goal of submitting licence applications for Australia and India next year. With enrolment into the Phase 3 trials completed earlier than planned, we have taken an important step toward addressing the unmet medical need for a convenient, singledose and affordable vaccine for travellers and endemic populations where JE is an ever-present threat."
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