Crucell Gains Approval and Moves to Recruitment for West Nile Vaccine Phase I Clinical Study
Crucell N.V. announced that it has obtained approval from Belgian authorities to test the safety, tolerability and immunogenicity of its whole-inactivated West Nile Virus vaccine in healthy volunteers. This opens the way for the imminent commencement of a Phase I clinical trial, with recruitment of volunteers underway.
The clinical trial for the human West Nile vaccine follows the June 2004 Israeli market authorization for a veterinary vaccine developed earlier together with the Kimron Veterinary Institute for use in geese. The first large commercial group of geese were recently vaccinated successfully at Kimron with two doses of the PER.C6®-based vaccine. The veterinary vaccine, which produced excellent safety data and almost 100% efficacy in challenge experiments, provides strong proof-of-concept for Crucell's human vaccine, as it protects against the Israel 1998 goose strain of West Nile virus which is closely related to the New York 1999 strain responsible for the outbreaks in the US.
Since its emergence in New York in 1999, West Nile virus has spread throughout the entire US. Primarily transmitted through the bite of infected mosquitoes, it can cause a fatal form of encephalitis, or inflammation of the brain, in humans and some animals. Health authorities in the US now view the disease as a recurring threat, surfacing every summer with warm and humid weather. In 2005, 2,775 recorded cases have so far claimed 98 lives.
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