At-risk patients include neonates, patients with indwelling catheters and patients undergoing certain types of surgery. The phase I study will evaluate safety and immune response of the vaccine in healthy volunteers.
There are numerous species of staph bacteria, but S. aureus and S. epidermidis are responsible for almost all staph infections in the hospital. S. epidermidis usually inhabits the human skin and nasal surfaces, and can spread to the blood through breaks in the nasal membranes and the skin. S. epidermidis has the same level of resistance to antibiotics as S. aureus bacteria.
The new study builds on the extensive clinical data supporting the Nabi’s vaccine to prevent S. aureus infections, StaphVax. StaphVax is in phase III clinical trials to prevent S. aureus infections in end-stage renal disease patients. In addition, immunogenicity studies in the US and UK are underway in orthopedic surgery patients who are at high-risk of developing S. aureus infections.