Investigational Clostridium Difficile Vaccine Press Release
In a press release from May 19, 2014, the following positive results were reported:
“C. diff infection threatens the many people who frequently use antibiotics, as well as older hospitalized patients and residents in long-term healthcare facilities,” said Jamshid Saleh, M.D., who participated in Phase II and is currently the principal investigator for the Phase III trial at Northern California Clinical Research Center in Redding, California. “It would be great if we could offer patients a way to help prevent this contagious and debilitating disease versus just treating it after it happens.”
The Phase II vaccine study was a randomized, multi-center trial split into two stages. The first, conducted with 455 volunteers, was placebo-controlled, double-blind and designed for dose and formulation selection. The second, which included 206 additional volunteers, was designed to compare the dose and formulation chosen in the first stage against two alternate dosing schedules. Volunteers in the study were adults aged 40-75 years who were at risk of CDI due to impending hospitalization or residence in a long-term healthcare facility.
“In this trial, we saw a significant increase in antibody production against C. diff toxins, across all dosing schedules and volunteer ages,” said Guy De Bruyn, MBBCh MPH, Director, Clinical Development, Sanofi Pasteur, who presented the data at ASM. “These results provide a strong foundation for our efforts to develop and offer a vaccine to prevent first occurrence CDI.”
For the full press release about the investigational Clostridium Difficile vaccine, please click here.
At JBR Clinical Research we appreciate our opportunity to not only assist in clinical trials and medical research, but to also be part of the much needed health solutions for our community and world. If you have questions about this clinical trial or about JBR Clinical Research, please feel free to contact us at 801-261-2000.
