Nabi Initiates StaphVAX Immunogenicity Study in Orthopedic Surgery Patients
Nabi Biopharmaceuticals has initiated the first clinical study for StaphVAX (Staphylococcus aureus Polysaccharide Conjugate Vaccine) in Europe.
This study is being conducted in the UK in patients undergoing orthopedic surgery with implantation of prosthetic devices. These patients are at a higher risk of developing S. aureus bacteremia because of the invasive nature of the surgery and implantation of an artificial device that can provide a focal point for bacterial growth.
The immunogenicity study will evaluate a total of 200 patients in the UK who are undergoing orthopedic surgery with a prosthetic device. The study is designed to evaluate the safety of StaphVAX and antibody levels developed over a six-week period, and to provide evidence that this broader, at-risk group can achieve antibody levels equal to or greater than the levels proven to be protective in immunocompromised ESRD patients. The company expects the study to be completed in 2005.
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