Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00071214
• Other study ID #: Nabi-1371
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2003
• Last updated: July 7, 2006
• Start date: September 2003
• Est. completion date: September 2005

Study information

• Verified date: July 2006
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3600
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency
• Staphylococcal Infections

Intervention

Biological:
• S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documented S. aureus invasive infection, weeks 3-35
Secondary	Documented S. aureus invasive infection in other time periods
Secondary	Immunogenicity at mulitple time points
Secondary	Safety
Secondary	Health economics

External Links

•   Nabi Biopharmaceuticals