Pfizer Inc. announced the enrollment of the first patient in a Phase 2b clinical trial of its investigational Staphylococcus aureus multi-antigen vaccine in adults undergoing elective spinal fusion surgery, according to a company press release.
According to Pfizer, patients who develop a Stapylococcus aureus infection have worse outcomes following surgery and an increased rate of mortality compared with noninfected patients. Surgical site infections (SSI) by S. aureus account for approximately 20% of all SSIs in the United States., and are associated with an estimated annual treatment cost of $12.3 billion.
An estimated 2,600 patients will be enrolled in the trial. Researchers will measure the number of patients in each treatment group with postoperative S. aureus bloodstream infections and/or deep incisional or organ/space surgical site infections occurring within 90 days after elective posterior instrumented lumbar spinal fusion.
Secondary outcomes in the study will measure postoperative S. aureusbloodstream infections and/or deep incisional or organ/space surgical site infections occurring within 180 days after surgery. Also, researchers will measure S. aureus SSIs within 90 and 180 days after surgery.
The study is estimated to be completed by 2017.
Pfizer’s multi-antigen S. aureus vaccine is designed to prevent a wide-range of clinical disease manifestations caused by S. aureus. The FDA fast-tracked the vaccine in February 2014.
