The collective mindset of the healthcare industry in the U.S. is shifting from treating conditions to preventing them. In a nutshell, providers are trying to keep patients healthy so they don't come to the hospital.
Following this philosophy is Swiftwater, Pa.-based Sanofi Pasteur's vaccine, the only candidate in phase III trials focused on Clostridium difficile infection prevention instead of treatment.
The vaccine uses a technique common in preventive vaccines called toxoiding, where the C. diff toxins responsible for infection are extracted, de-activated and then reintroduced so the body can generate an immune response. Toxoiding is also the process by which common preventive vaccines, such as the tetanus and diphtheria vaccines, function.
"We essentially are taking this platform and adapting it to C. diff," says Sanjay Gurunathan, MD, associate vice president and head of global clinical development at Sanofi Pasteur. "It's the simplicity of the approach and the track record that speak to the approach and the design."
Sanofi Pasteur's vaccine passed its phase II trial, meeting its objectives, and patient reactions were generally mild and temporary. Additionally, the phase II trial indicated all vaccine doses were deemed safe and acceptable.
Now, the phase III clinical trial for the vaccine, called Cdiffense, is examining the prevention efficacy of a high-dose plus adjuvant vaccine formulation. Not only is Cdiffense the only phase III clinical trial focused on infection prevention, but the scope of the trial makes the study stand out, Dr. Gurunathan says.
"The unique part of the study is that there potentially will be 15,000 volunteers in 17 countries spread over five continents at approximately 200 research sites around the entire globe," he says. "The global impact of the results [is] going to be quite significant."
Additionally, due to its status as the sole vaccine focused on prevention, the U.S. Food and Drug Administration granted the vaccine fast track designation, an expedited review and development process reserved for drug programs that have the potential to fulfill an unmet medical need.
And the need for infection prevention is looming and ever-growing. When looking at the estimated $9.8 billion in healthcare costs spent on treating healthcare-associated infections, focusing on prevention and avoiding those exorbitant costs is a welcome idea.
"What we are trying to do is prevent people from getting an infection through the vaccine approach. There's a lot to be said about prevention being better than cure," Dr. Gurunathan says. "We hope that by preventing infection we can not only alleviate the complications of the disease for the person suffering from the disease but also have a significant economic impact on the healthcare system."
More Articles on C. diff:
Study: Multi-Hospital Collaboration Could Significantly Reduce Spread of C. diff
Study: Dedicated Team, Standardized Processes for Cleaning C. Diff Rooms Improves Disinfection Rates
Patient Safety Tool: Clorox Visual Guide to C. diff Prevention