StaphVAX (Nabi).

StaphVAX is a bivalent polysaccharide- and protein-conjugated vaccine, directed against capsular Staphylococcus aureus types 5 and 8, which are associated with 80 to 90% of S aureus clinical infections. The vaccine is being developed by Nabifor the potential treatment of infections in kidney patients who are receiving peritoneal dialysis and are prone to serious staphylococcal infections [193495], [221403], [222643], [283114]. In February 2001, Nabi revealed that it was movingforward during the second quarter of 2001 with previously stated plans to conduct a boosting study of StaphVAX in patients with end-stage renal disease (ESRD). This study would be conducted in patients who were enrolled in the first phase III trial and the company expected completion by early 2002 [283114]. The company was also progressing with scale-up of the manufacturing process for commercial production of the vaccine. Nabi met with the FDA in December 2000 to review results from its phase III trial of StaphVAX in patients with ESRD. The FDA stated that a definitive demonstration of preventative efficacy in another well-designed, randomized and controlled clinical study would be required for licensing. At this time, Nabi was making plans for this second phase III trial, despite plans to appeal the FDA's decision [397729].