C difficile infection, which is characterized by diarrhea and colitis, represents one of the most common hospital acquired infections around the world. A new virulent strain of C difficile has also emerged, causing sharp increases in the number of infections and deaths associated with the infection in a number of countries including the UK, Canada, the Netherlands and the US.
A highly virulent strain of C difficile has resulted in outbreaks in 15 hospitals in the UK. At Stoke Mandeville Hospital in Buckinghamshire alone, this strain caused 12 deaths and infected 300 patients. C difficile infections also reached epidemic proportions in Quebec, Canada, where the number of C difficile cases doubled and the fatality rate increased by 60% between March 2000 and April 2004.
The phase I trial is designed to obtain information on the safety, tolerability and immunogenicity of the vaccine when administered at different dose levels. Acambis also plans to start a second phase I trial in elderly subjects.
No vaccine currently exists to protect individuals against C difficile and Acambis is the only company known to be developing a vaccine against it.
Dr Thomas Monath, chief scientific officer of Acambis, commented: “C difficile has long been a problem for hospitals but with the emergence of the new virulent strain the number of outbreaks in hospitals is rapidly increasing, resulting in higher numbers of infection and death. There is currently no effective means of preventing future outbreaks of C difficile.”
“Acambis is the only known company developing a vaccine to protect against C difficile infection and we are pleased to have entered the important clinical testing development stage,” added Dr Monath.