Nabi Biopharmaceuticals has initiated the first clinical study for StaphVAX (Staphylococcus aureus Polysaccharide Conjugate Vaccine) in Europe.
According to a company release, this study is being conducted in the United Kingdom (UK) in patients undergoing orthopaedic 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. S. aureus infections are the most common cause of hospital-acquired infections and are becoming increasingly resistant to antibiotics, rendering them significant causes of illness and death.
"Staph aureus infections, and methicillin resistant strains in particular, have become more prevalent amongst UK hospitalized patients," Professor Elizabeth Miller, head of the Centre for Infectious Immunization Department at England's Health Protection Agency said adding, "Infections caused by some of these MRSA strains are more difficult to treat because of resistance to several antibiotics. The goal in the UK, set by the Department of Health, is to reduce MRSA infections by 50 per cent by the year 2008. A novel Staphylococcus aureus vaccine would aim to reduce MRSA hospital-acquired infections in various patient groups such as the ones being studied in this clinical trial. Consideration of the use of vaccines to help reduce healthcare associated infections is something the Department of Health recommended in their strategy 'Winning Ways.'"
Henrik Rasmussen, senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals said, "For patients who develop these infections, the consequences are often devastating and typically involve new hospitalization or prolongation of hospital stay as well as repeat surgery. To add to the problem, staph aureus infections are highly resistant to commonly used antibiotics, with increasing resistance to Vancomycin, which is often described as the treatment of last resort. The purpose of the immunogenicity study is to demonstrate that StaphVAX is safe, well tolerated and results in an increase in anti-staphylococcal antibodies that is similar to what we have seen in patients with end-stage renal disease."
In January 2005, first license application (Marketing Authorization Application) submitted by Nabi Biopharmaceuticals for StaphVAX was accepted for review by the European Medicines Agency (EMEA). The initial indication being sought is for the prevention of S. aureus infections in kidney disease patients on haemodialysis for up to 40 weeks. The company intends to later file a supplemental MAA, including data from immunogenicity studies in other at-risk patient groups, seeking a broader indication for the use of the vaccine, the release added.