Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

Two part clinical trial designed to evaluate the efficacy of StaphVAX in adults on hemodialysis. Part A will evaluate the prevention of bacteremic infections in End Stage Renal Disease (ESRD) patients during the interval between 3 and 35 weeks after a single dose of StaphVAX. Part B of this study is designed to assess immunogenicity of a second [booster] dose of vaccine in patients completing Part A, and the cumulative (Part A + B) efficacy.

Eligible subjects must already be receiving chronic hemodialysis treatment from the centers participating in this study. Interested subjects should discuss enrollment with their nephrologist.

Inclusion criteria

• Age 18 years or older.
• Diagnosis of chronic end-stage renal disease with maintenance on hemodialysis continuously for at least eight (8) weeks prior to enrollment.
• Hemodialysis access using native vessel fistula or synthetic/heterologous graft (not catheter).
• Expectation of compliance with protocol procedures, and visit schedule.
• Negative serum pregnancy test in females of child-bearing potential (serum -HCG within 7 days prior to each study drug injection).
• Written informed consent.

Exclusion criteria

• Known serious S. aureus infection within 3 months of study entry.
• Known recurrent S. aureus infection of the current graft.
• Known active viral or bacterial infection or symptoms/signs consistent with such an infection with the two weeks prior to injection of investigational product. Mild intercurrent viral illness with a temperature of 100.6F or less does not require exclusion, if in the judgement of the investigator this illness will not interfere with the evaluation of the vaccine.
• Known HIV infection (testing not required for protocol).
• Known hypersensitivity or previous anaphylaxis to polysaccharides or polysaccharide-conjugate vaccines or to components of such vaccines.
• Known or suspected abuse of any drugs, prescribed or illicit, in the past year.
• Current use of immunosuppressive or immunomodulatory drugs (including systemic glucocorticoids, chlorambucil, cyclophosphamide, azathioprine, methotrexate, cyclosporine, mycophenolate, human immune globulin in excess of 0.2 g/Kg per month, any monoclonal antibody specific for any human leukocyte subset or cytokine, or any interferon preparation), except low-dose physiologic replacement glucocorticoid therapy (Less than or equal to 10 mg of prednisone or equivalent per day).
• Known malignancy or treatment for malignancy within the past six months, other than basal cell or squamous cell carcinoma of the skin.
• Use of investigational drugs, products, or devices within 30 days prior to vaccine injection.
• Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardized the quality of the data to be generated.
• Previous administration of StaphVAX