|Clostridium difficile bacterium--Courtesy of CDC|
The race to a Clostridium difficile vaccine has been dominated by Big Pharmas Sanofi ($SNY) and Pfizer ($PFE), whose candidates were fast-tracked by the FDA in 2010 and 2014, respectively. Allegheny General Hospital in Pittsburgh announced on Wednesday that it will participate in trials of an investigational vaccine as Sanofi moves it into Phase III.
AGH will join more than 200 sites in 17 countries in the trial, dubbed Cdiffense. Enrollment for the trial began in 2013 and the Big Pharma aims to recruit 15,000 participants. The randomized, observer-blind, placebo-controlled study involves adults older than 50 who are planning for a hospitalization of more than 72 hours for a surgical procedure.
The infection commonly affects older adults in hospitals or long-term care facilities and tends to occur after antibiotic use.
In May 2014, Sanofi revealed positive Phase II results for its candidate. The vaccine met its primary objectives and most trial participants had mild, short-lived reactions.
According to a statement, C. diff is becoming a leading cause of healthcare-associated infections worldwide in a time where most types of HAIs are declining. Approximately 500,000 Americans are infected with C. diff each year and 14,000 deaths are attributed to the infection each year, AGH said. No vaccine exists against C. diff infection.
Sanofi's candidate is leading the race, while Pfizer and Valneva both have candidates in Phase II.
- read the release
- here's more about the Cdiffense trial