Acambis' C difficile vacc shows promise in study

UK biotechnology group Acambis says that the results of a Phase I trial of its Clostridium difficile vaccine show promise, with all study subjects showing antibody responses four weeks after administration of the vaccine. C difficile is the leading cause of antibiotic-associated diarrhoea in hospitals and is estimated to cost the US health care system $1.0 billion a year.

The study, which enrolled 50 healthy adult subjects, was a randomized, double-blind, placebo-controlled program designed to establish the compound's safety, tolerability and immunogenicity. Analysis of the results showed that all dosages of the drug were well-tolerated, with antibody responses around 10 times higher in vaccine-treated patients than in those receiving placebo.

The firm says that no subjects experienced unexpected or serious adverse reaction, with the most commonly observed side effects including mild tenderness, redness and pain at the injection site. The company also says that, based on the data from this study, it will initiate a Phase II study of the compound before the end of the year.