Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Efficacy of StaphVAX, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis

Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus.

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