Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Staphylococcal Infections Kidney Failure, Chronic

Keywords

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Staphylococcal infection Gram positive bacteria Staphylococcus Staphylococcus aureus Staphylococcus aureus infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Matt Hohenboken, MD, PhD

Role: STUDY_DIRECTOR

Nabi Biopharmaceuticals

References

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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.

Reference Type DERIVED

PMID: 25483694 (View on PubMed)

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.