Intercell AG today announced that a Phase I clinical trial with the company's vaccine candidate IC84 to prevent disease caused by the bacterium Clostridium difficile (C. difficile) has started. The pathogen is one of the main causes of nosocomial diarrhea.
Intercell's vaccine candidate is a recombinant protein vaccine consisting of two truncated toxins A and B from Clostridium difficile. The toxins are known to be disease-causing and anti-toxin immunity can be protective. The vaccine candidate will be tested with or without the adjuvant aluminum hydroxide.
This Phase I trial is a first-in-man study to obtain safety and immunogenicity data in a small population of healthy adults aged 18-65 years in the first part of the study as well as from healthy elderly subjects above 65 years of age in a second part of the study, the latter age group representing the main target population for a Clostridium difficile vaccine. 60 healthy adults and up to 100 elderly subjects will be enrolled in this open-label study. Three different alum-adjuvanted vaccine concentrations will be tested; two of the three vaccine concentrations will also be tested without adjuvant.
"The initiation of this clinical Phase I trial is an important step to further strengthen Intercell's leading position in the development of vaccines against hospital-acquired infections",Â says Intercell's COO, Thomas Lingelbach.
There is no vaccine available against Clostridium difficile, which represents the leading cause of nosocomial diarrhea in the U.S. and EU and is an increasing burden to the health care system. The disease affects in particular elderly patients with prolonged antibiotic treatment and patients with underlying co-morbidities or immunocompromising conditions. Antibiotic treatment is the current standard of care of Clostridium difficile-associated disease but has its limitations due to increasing treatment failures attributable to antibiotic resistance and disease relapse in up to 30 percentÂ of patients after discontinuation of the treatment.
Potential indications for a Clostridium difficile vaccine include community prophylaxis for the elderly, prophylaxis in hospitalized patients with particular risk factors for Clostridium difficile-associated disease and the prevention of relapsing disease.