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
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 |
Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus.
Status | Completed |
Enrollment | 3600 |
Est. completion date | September 2005 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nabi Biopharmaceuticals |
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 |
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