ROCKVILLE, Md. -- Nabi Biopharmaceuticals announced that the company's StaphVAX(R) (Staphylococcus aureus Polysaccharide Conjugate Vaccine) continues to be on track towards achieving two important development milestones: First, filing its Marketing Authorization Application (MAA) in the European Union by end of 2004 and second, filing its Biologics License Application (BLA) in the United States by end of 2005. The company is rapidly advancing its confirmatory phase III trial of StaphVAX for the prevention of S. aureus bacteremia (bloodstream infections) to support this filing. After a blinded assessment of the overall S. aureus bacteremia event rates in this trial, the company reported that the infection rate thus far is consistent with the assumptions used in the design of the study.
"We continue to make excellent progress with our StaphVAX development program. After completing production of the vaccine consistency lots ahead of schedule, the preparation of the manufacturing section of our MAA for registration in Europe is on track and the MAA is expected to be filed before the end of this year," said Henrik S. Rasmussen, MD, PhD, senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals. "In addition, we have been carefully monitoring the infection event rate in our confirmatory phase III trial and based on our analysis, we are at virtually the same overall event rate in this trial as we were in the first StaphVAX trial. This is very reassuring and indicates to us that there has not been a change in overall S. aureus infection rates in end-stage renal disease patients between the first trial and this confirmatory study."
After a blinded assessment of the overall S. aureus bacteremia event rates in this ongoing confirmatory phase III, double-blinded trial, the company reported that the infection rate in this study is consistent with that found at the same point in the company's first phase III trial. Specifically, the primary S. aureus infection rate in this trial is 3.1 percent, which is virtually identical to the cumulative (placebo + active treatment) event rate in the first phase III efficacy trial (also 3.1 percent). As expected from previous clinical data, approximately 82 percent of isolates to date have represented serotype five or serotype eight infections. Nabi Biopharmaceuticals will next provide full results of the trial when the confirmatory phase III trial is completed in 2005.
In addition to reviewing infection event rates, the company also reported that the trial has been over-enrolled, which will result in further improvement in the statistical powering of the trial. A total of 3,976 patients were enrolled versus a target enrollment of 3,600 patients. The company made a decision to stop dosing in the study after a total of 3,447 patients had been randomized for injection with either StaphVAX or placebo. This was significantly greater than the trial design target of 3,240 patients. Patients in the trial were enrolled at over 400 clinical trial sites, and nearly 500 board-certified nephrologists (corresponding to approximately 10 percent of board-certified nephrologists in the United States) have participated in this study.
Dr. Rasmussen continued, "We are also encouraged by the level of excitement we encountered in the nephrology community about StaphVAX, as exemplified by the over-enrollment into this study and the number of physicians who expressed interest in enrolling their patients. The final sample size gives this study approximately 98 percent power to pick up an efficacy rate of 60 percent or greater and approximately 90 percent power to pick up an efficacy rate of 50 percent. We believe this high interest in enrolling patients is a clear validation of the magnitude of the medical challenge StaphVAX is being developed to address."
Source: Nabi Biopharmaceuticals
Stay prepared and protected with Infection Control Today's newsletter, delivering essential updates, best practices, and expert insights for infection preventionists.
Breaking the Cycle of Silence: Why Sharps Injuries Go Unreported and What Can Be Done
Published: July 24th 2025 | Updated: July 23rd 2025Despite decades of progress in health care safety, a quiet but dangerous culture still lingers: many health care workers remain afraid to report sharps injuries, fearing blame more than the wound itself.
US Withdrawal From UNESCO Signals a Dangerous Step Back for Global Science
July 22nd 2025In a decision heavy with consequence and light on foresight, the US has once again chosen to walk away from UNESCO, leaving behind not just a seat at the table, but a legacy of global scientific leadership that now lies in question.
Pathogen Pulse: Facilities Need the SPD, Yersinia Enterocolitica Outbreak, and More
July 22nd 2025From unsterilized surgical tools in Colorado to a years-long methicillin-resistant Staphylococcus aureus (MRSA) outbreak in Virginia and a surging measles crisis in Canada, recent headlines reveal the fragile front lines of infection prevention and the high stakes when systems fail.
Telemedicine's Transformative Role in PPE Distribution and Sterile Equipment Management
July 22nd 2025In an era defined by digital transformation and post-pandemic urgency, telemedicine has evolved beyond virtual visits to become a vital infrastructure for delivering personal protective equipment (PPE) and managing sterile supplies. By enabling real-time forecasting, remote quality control, and equitable distribution, telemedicine is revolutionizing how health care systems protect both patients and providers.
Reducing Hidden Risks: Why Sharps Injuries Still Go Unreported
July 18th 2025Despite being a well-known occupational hazard, sharps injuries continue to occur in health care facilities and are often underreported, underestimated, and inadequately addressed. A recent interview with sharps safety advocate Amanda Heitman, BSN, RN, CNOR, a perioperative educational consultant, reveals why change is overdue and what new tools and guidance can help.