The Brigham and Women’s Hospital departments of Orthopaedic Surgery and Neurosurgery are enrolling patients to investigate S. aureus vaccine (SA4Ag) in the prevention of postoperative S. aureus in posterior spinal fusion procedures with multilevel instrumentation.
Orthopaedic surgeons and neurosurgeons at Brigham and Women’s Hospital (BWH) are participating in a Phase 2B, multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of a staphylococcus aureus 4-antigen vaccine SA4Ag in adults (aged 18 to <86) undergoing elective open posterior spinal fusion procedures with multilevel instrumentation.
“Postoperative S. aureus infections can be devastating and the problem represents a major unmet medical need. There is currently no vaccine available to prevent S. aureus and if SA4Ag is proven to be efficacious, it could dramatically decrease the rates of these infections in spinal fusion surgery, and perhaps have paradigm-shifting potential,” says James D. Kang, MD, principal investigator of the study, and chair of the Department of Orthopaedic Surgery at BWH.
As part of the Comprehensive Spine Center, which brings together orthopaedic surgeons, neurosurgeons, and others to provide multidisciplinary spine treatment in a single location, Dr. Kang is collaborating with spine surgeons, Christopher M. Bono, MD, and Jay M. Zampini, MD, in the Department of Orthopaedic Surgery as well as with John H. Chi, MD, MPH, director of the Neurosurgical Spine Service, and Yi Lu, MD, PhD, a neurosurgeon within the Division of Neurosurgery at BWH.
“Brigham and Women’s has always been at the forefront of participating in innovative clinical studies that might change the way we do things. The Comprehensive Spine Center has the infrastructure, clinical research culture and prominence that is highly amenable to this vaccine study,” says Dr. Kang.
The Pfizer-sponsored, multicenter study, named STRIVE (STaphylococcus aureus SuRgical Inpatient Vaccine Efficacy), officially began in July 2015 and includes more than 80 sites across the USA, Canada, UK, France, Spain, Germany, and Japan. Over the next several years, sites will recruit approximately 6,000 patients.
The S. aureus vaccine works by targeting multiple virulence mechanisms. To date, SA4Ag has been proven to be safe in 1,000 healthy subjects who have received the S. aureus vaccine in Phase 1/2 clinical trials. Injection site reactions generally were mild or moderate in severity, and no vaccine-related serious adverse events or deaths have been reported.
BWH investigators have recently begun enrolling patients, and hope to recruit between 50 and 100 patients over the next year. Study subjects will be vaccinated with SA4Ag or placebo 10 to 60 days prior to undergoing elective open posterior spinal fusion with multilevel instrumentation. Subjects participate for six to eight months, and must be willing to complete an electronic diary for 10 days after vaccination.
“If this vaccine is proven efficacious, it could potentially eradicate S. Aureus from the surgical site in spine surgeries. If that happens, it’s possible the vaccine could be applied to other surgeries, such as hip or knee replacements. It could be the standard of care in the future for preventing these devastating infections,” says Dr. Kang.