NCT00071214

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

July 11, 2006

Status Verified

July 1, 2006

First QC Date

October 15, 2003

Last Update Submit

July 7, 2006

Conditions

Staphylococcal InfectionsKidney Failure, Chronic

Keywords

Staphylococcal infectionGram positive bacteriaStaphylococcusStaphylococcus aureusStaphylococcus aureus infection

Outcome Measures

Primary Outcomes (1)

  • Documented S. aureus invasive infection, weeks 3-35

Secondary Outcomes (4)

  • Documented S. aureus invasive infection in other time periods

  • Immunogenicity at mulitple time points

  • Safety

  • Health economics

Interventions

S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate VaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Known serious S. aureus infection within 3 months of study entry.
  • Known recurrent S. aureus infection of the current graft.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Fattom A, Matalon A, Buerkert J, Taylor K, Damaso S, Boutriau D. Efficacy profile of a bivalent Staphylococcus aureus glycoconjugated vaccine in adults on hemodialysis: Phase III randomized study. Hum Vaccin Immunother. 2015;11(3):632-41. doi: 10.4161/hv.34414.

    PMID: 25483694DERIVED

  • Li Y, Friedman JY, O'Neal BF, Hohenboken MJ, Griffiths RI, Stryjewski ME, Middleton JP, Schulman KA, Inrig JK, Fowler VG Jr, Reed SD. Outcomes of Staphylococcus aureus infection in hemodialysis-dependent patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):428-34. doi: 10.2215/CJN.03760708. Epub 2008 Dec 31.

    PMID: 19118117DERIVED

MeSH Terms

Conditions

Staphylococcal InfectionsKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matt Hohenboken, MD, PhD

    Nabi Biopharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2003

First Posted

October 17, 2003

Study Start

September 1, 2003

Study Completion

September 1, 2005

Last Updated

July 11, 2006

Record last verified: 2006-07