NABI BIOPHARMACEUTICALS LAUNCHES STAPHVAX STUDY

Nabi Biopharmaceuticals has initiated a repeated dosing study designed to evaluate the ability of StaphVAX (Staphylococcus aureus Polysaccharide Conjugate Vaccine) to provide continuous protection in patient populations who are at high chronic risk for S. aureus infections. The trial will evaluate StaphVAX in end-stage renal disease (ESRD) patients on dialysis who are at high risk of contracting a S. aureus infection during their invasive and long-term treatment.

The study is a randomized, placebo-controlled study with two arms, and is comprised of a subset of 460 ESRD patients participating in ongoing Phase III StaphVAX trials. One arm of the study will be comprised of 230 patients: 115 patients will receive two injections of the placebo eight months apart; and 115 patients will receive two injections of the placebo 12 months apart. The second arm will be comprised of another 230 patients: 115 patients will receive two injections of StaphVAX eight months apart; and 115 patients will receive two injections of StaphVAX 12 months apart. The goal of the study is to determine, after an initial booster dose at eight months, at which future time points repeat doses of StaphVAX would need to be given to achieve the optimal antibody levels in ESRD patients.