Acambis initiates phase 1 trial of clostridium difficile vaccine

By Angela McDaniels

Seattle, Nov. 28 - Acambis plc said it has initiated a phase 1 clinical trial of its investigational vaccine against clostridium difficile in healthy elderly subjects.

The phase 1 trial is designed to obtain information on the safety, tolerability and immunogenicity of Acambis' clostridium difficile vaccine when administered at different dose levels, the company said.

The randomized, double-blind, placebo-controlled study is being conducted in the United States and follows an initial phase 1 safety and immunogenicity trial in healthy young adults.

Acambis said it is the only company with a vaccine against clostridium difficile in clinical development. Its vaccine is designed to provide protective immunity against toxins A and B, the toxins responsible for the development of clostridium difficile-associated disease.

The primary market for the vaccine is those most at risk of clostridium difficile-associated disease, such as the elderly, individuals entering nursing homes and those suffering from chronic diseases.

"We are pleased to be progressing our vaccine candidate into clinical testing in one of [its] main target populations," said Thomas Monath, chief scientific officer of Acambis, in a company news release.

Clostridium difficile infection, which is characterized by diarrhea and colitis, is one of the most common hospital-acquired infections around the world, the company said.

A hyper-virulent, hyper-toxigenic strain of clostridium difficile has recently emerged and is believed to be responsible for sharp increases in the number of infections and deaths associated with the infection in countries including the United Kingdom, Canada and the United States, the company said.

Acambis develops vaccines and is based in Cambridge, England, and Cambridge, Mass.

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