Cambridge, UK-based Acambis has reported positive results from a pivotal Phase III safety trial of ChimeriVax-JE, its investigational single-dose vaccine against Japanese encephalitis, along with encouraging preliminary data from a separate, Phase III efficacy trial.
The pivotal Phase III multicenter randomized, double-blind placebo-controlled trial evaluated the safety and tolerability of ChimeriVax-JE in 2,004 healthy adults. The total number of subjects reporting adverse events was comparable between those vaccinated with ChimeriVax-JE and people on placebo.
A pivotal efficacy trial was designed to test the non-inferiority of ChimeriVax-JE to a licensed JE vaccine, JE-VAX. While the study is still blinded, early serology data indicate an overall seroconversion rate of approximately 98% in evaluable subjects receiving either a single dose of ChimeriVax-JE or three doses of JE-VAX.
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