Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

July 7, 2006 updated by: Nabi Biopharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

3600

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Documented S. aureus invasive infection, weeks 3-35

Secondary Outcome Measures

Outcome Measure
Safety
Health economics
Documented S. aureus invasive infection in other time periods
Immunogenicity at mulitple time points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nabi Biopharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

October 15, 2003

First Submitted That Met QC Criteria

October 16, 2003

First Posted (Estimate)

October 17, 2003

Study Record Updates

Last Update Posted (Estimate)

July 11, 2006

Last Update Submitted That Met QC Criteria

July 7, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nabi-1371

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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