Sanofi Pasteur begins Phase III C. Diff vaccine trial

Vaccines division of Sanofi has begun recruiting volunteers in the UK for the multi-national trial

Sanofi Pasteur, the vaccines division of French drugmaker Sanofi, has started a Phase III trial called CDiffense to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of Clostridium difficile infection (CDI).

The Cdiffense programme has begun recruiting volunteers in the UK for the trial. This multi-centre, multi-national trial will include up to 15,000 adults at 200 sites across 17 countries.

The investigational C. diff vaccine produces an immune response that targets the toxins generated by C. diff bacteria, which can cause inflammation of the gut and lead to diarrhoea. It ultimately may help prevent a future infection from occurring

‘With the emergence of difficult-to-manage strains of C. diff, CDI has become more frequent, more severe and more difficult to treat in recent years, raising concerns about how to control it and prevent transmission,’ said John ShiverSenior Vice President for Research & Development at Sanofi Pasteur. ‘Vaccination could be an efficacious, cost-effective and important public health measure to protect individuals from C. diff.’