US-based drugmaker Pfizer has commenced the Phase IIb clinical trial of its investigational Staphylococcus aureus (S. aureus) multi-antigen vaccine (PF-06290510) in adults undergoing elective spinal fusion surgery.
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The company has enrolled the first patient in the Saphylococcus aureus surgical inpatient vaccine efficacy (STRIVE) trial to study the safety and efficacy of the vaccine to find out if it prevents postoperative invasive S. aureus infections in patients undergoing elective spinal surgery.
The vaccine is designed to prevent a wide-range of clinical disease manifestations, caused by S. aureus, by facilitating killing of the bacteria at the early stages of invasive infection by targeting multiple virulence mechanisms.
Pfizer vaccine research and development senior vice-president and chief scientific officer Dr Kathrin Jansen said: “To date, there is no licenced vaccine available to prevent invasive S. aureus disease.
“We believe results from this study, if positive, will bring us closer to a potential preventive measure for this challenging disease that is associated with considerable morbidity and mortality.”
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By GlobalDataThe company plans to enrol around 2,600 subjects in the study, which is expected to complete in 2017.
The primary outcome of the study will evaluate the number of subjects in each treatment group with postoperative S. aureus blood stream infections and deep incisional or organ/space surgical site infections occurring within 90 days after elective posterior instrumented lumbar spinal fusion.
In addition, the secondary outcomes will assess postoperative S. aureus blood stream infections and deep incisional or organ/space surgical site infections occurring within 180 days after surgery, and postoperative S. aureus surgical site infections occurring within 90 and 180 days after elective posterior instrumented lumbar spinal fusion.
February 2014 saw the firm’s S. aureus vaccine receive fast track status from the US Food and Drug Administration (FDA).
Image: The scanning electron micrograph (SEM) shows a strain of Staphylococcus aureus bacteria taken from a vancomycin intermediate resistant culture (VISA). Photo: courtesy of Janice Haney Carr.
