ACE BioSciences Begins Landmark Phase IIb Proof of Concept Study with its Travellers’ Diarrhoea Vaccine
News Dec 01, 2008
ACE BioSciences, the company that develops vaccines to fight serious bacterial infections, has begun a landmark Phase IIb Proof of Concept study with ACE393, which is said to be the world’s first commercial Campylobacter Travellers’ Diarrhoea (TD) vaccine.
An interim analysis of the primary outcome will be complete by March 2009 at which point ACE BioSciences should be in a strong position to partner the project.
During the trial 40 subjects will receive the vaccine as two injections administered three weeks apart. A further twenty subjects will receive placebo injections. Three weeks after vaccination, subjects will be admitted to hospital and challenged with Campylobacter by drinking a suspension containing 100,000 bacteria. They will then be closely monitored for symptoms, which should develop within 48 hours. The extent of protection from moderate to severe diarrhoea will be evaluated as the end point for efficacy.
Any patient who experiences diarrhoea will receive antibiotic treatment and only be allowed home when the infection has successfully been addressed. Patients will be monitored for four weeks and then followed up at three and six months post-trial.
The study is being managed by ACE BioSciences. It is being undertaken at the SNBL Clinical Research Centre, Baltimore, Maryland, US under the auspices of Dr Al-Ibrahim as Principal Investigator and with the support of the Johns Hopkins University and the University of Vermont, which are providing immunology and microbiology input.