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Acambis announces encouraging data from Phase 2 trial of West Nile virus vaccine
13 Sep 2006 -
Acambis plc announced preliminary results from the first component of a Phase 2 clinical trial of its investigational vaccine against West Nile virus, ChimeriVax-West Nile.
In the first part of this Phase 2 trial, Acambis evaluated the safety, tolerability and immunogenicity of a single dose of ChimeriVax-West Nile in healthy adults aged 18 to 40. In total, 112 healthy adults were enrolled into this part of the randomised, double-blind placebo-controlled trial, which tested three different dose levels of ChimeriVax-West Nile.
The primary immunogenicity endpoint in the trial was seroconversion rate, i.e., the percentage of subjects who generated neutralising antibodies at a titre of at least 1:10. Over 97% of all subjects who received ChimeriVax-West Nile seroconverted 28 days after a single vaccination. Most of the adverse events were mild in nature.
Acambis' Chief Executive Officer Gordon Cameron welcomed the results of the study, saying: "We are very encouraged by these results, especially the high immune response generated in subjects by just a single dose of ChimeriVax-West Nile. In addition to supporting our Phase 1 data, these findings will enable us to advance our Phase 2 trial into older adults, including those within the 50-plus age group who are considered by the US Centers for Disease Control and Prevention to be most at risk from severe disease resulting from West Nile virus infection."
The second stage of the trial will involve healthy adults aged 41 and over and will assess the safety, tolerability and immunogenicity of ChimeriVax-West Nile compared to placebo. Recruitment for this stage of the trial is scheduled to start in the fourth quarter of 2006.
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