Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00071214
First received: October 15, 2003
Last updated: July 7, 2006
Last verified: July 2006
  Purpose

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


Condition Intervention Phase
Staphylococcal Infections
Kidney Failure, Chronic
Biological: S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:
  • Documented S. aureus invasive infection, weeks 3-35

Secondary Outcome Measures:
  • Documented S. aureus invasive infection in other time periods
  • Immunogenicity at mulitple time points
  • Safety
  • Health economics

Estimated Enrollment: 3600
Study Start Date: September 2003
Estimated Study Completion Date: September 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071214

Sponsors and Collaborators
Nabi Biopharmaceuticals
Investigators
Study Director: Matt Hohenboken, MD, PhD Nabi Biopharmaceuticals
  More Information

Additional Information:
No publications provided by Nabi Biopharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00071214     History of Changes
Other Study ID Numbers: Nabi-1371
Study First Received: October 15, 2003
Last Updated: July 7, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Nabi Biopharmaceuticals:
Staphylococcal infection
Gram positive bacteria
Staphylococcus
Staphylococcus aureus
Staphylococcus aureus infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Renal Insufficiency
Kidney Failure, Chronic
Staphylococcal Infections
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014