Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00071214
Recruitment Status : Completed
First Posted : October 17, 2003
Last Update Posted : July 11, 2006
Information provided by:
Nabi Biopharmaceuticals

October 15, 2003
October 17, 2003
July 11, 2006
September 2003
Not Provided
Documented S. aureus invasive infection, weeks 3-35
Not Provided
Complete list of historical versions of study NCT00071214 on Archive Site
  • Documented S. aureus invasive infection in other time periods
  • Immunogenicity at mulitple time points
  • Safety
  • Health economics
Not Provided
Not Provided
Not Provided
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Staphylococcal Infections
  • Kidney Failure, Chronic
Biological: S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Nabi Biopharmaceuticals
Not Provided
Study Director: Matt Hohenboken, MD, PhD Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP