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Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

Primary Purpose

Staphylococcal Infections, Kidney Failure, Chronic

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine
Sponsored by
Nabi Biopharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcal Infections focused on measuring Staphylococcal infection, Gram positive bacteria, Staphylococcus, Staphylococcus aureus, Staphylococcus aureus infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    October 15, 2003
    Last Updated
    July 7, 2006
    Sponsor
    Nabi Biopharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00071214
    Brief Title
    Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Nabi Biopharmaceuticals

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Staphylococcal Infections, Kidney Failure, Chronic
    Keywords
    Staphylococcal infection, Gram positive bacteria, Staphylococcus, Staphylococcus aureus, Staphylococcus aureus infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    3600 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine
    Primary Outcome Measure Information:
    Title
    Documented S. aureus invasive infection, weeks 3-35
    Secondary Outcome Measure Information:
    Title
    Documented S. aureus invasive infection in other time periods
    Title
    Immunogenicity at mulitple time points
    Title
    Safety
    Title
    Health economics

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matt Hohenboken, MD, PhD
    Organizational Affiliation
    Nabi Biopharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25483694
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    19118117
    Citation
    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.
    Results Reference
    derived

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    Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

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