A medical research study to evaluate an investigational vaccine against Staphylococcus aureus (staph) infections, is accepting study participants.
The Justin Parker Neurological Institute together with Boulder Neurosurgical & Spine Associates are participating in the STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) research study. Approximately 1 to 3 patients in every 100 develop a surgical site infection after spinal surgery. The STRIVE study will evaluate the safety and effectiveness of this vaccine when administered to adults undergoing an elective spinal fusion surgical procedure.
What is this study about?
- To evaluate the safety and efficacy of an investigational vaccine when administered to adults undergoing a spinal fusion surgical procedure.
- To investigate whether a single vaccination given 10-60 days before spinal surgery can prevent Staphylococcus aureus (staph) infections.
Prior to making a new vaccine available to doctors or their patients:
- Drug companies must test the investigational vaccine in a series of clinical research trials.
- The safety and tolerability of this current investigational vaccine for Staphylococcus aureus have been studied in healthy adult subjects in two previous clinical trials.
- The next step is to study the safety and efficacy of this investigational vaccine in patients planning a spinal fusion surgical procedure.
This study is planning to enroll:
- 2,600 adults in the US, Canada, and Europe
- Ages 18 to 85 years of age
- Who are scheduled to have spinal fusion surgery
- The information collected from this study may help in the development of a vaccine to prevent disease caused by Staphylococcus aureus.
You may be eligible for this study if you are:
- 18 to 85 years of age
- Scheduled to undergo an elective spinal fusion procedure
- Available for the entire duration of the study
- Willing and able to comply with study procedures and sign an informed consent document
- Willing to complete health questions, a physical exam and required tests to determine study qualification