Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Staphylococcal Infections, Chronic Kidney Failure

In brief

This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.

Key facts

Study ID

NCT00130260

Run by

Nabi Biopharmaceuticals

People needed

99

Starts

2005-08-01

Expected to finish

2006-04-01

Last updated by the study team

2008-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participation in prior study Nabi-1371
• Written informed consent
• Negative serum pregnancy test, where appropriate
• Expect to comply with protocol procedures and schedule

You may not qualify if…

• Known HIV
• Immunomodulatory drugs
• Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer)
• Active infection in the 2 weeks prior to study injection
• Serious S. aureus infection within the last 2 months prior to injection
• Hypersensitivity to components of StaphVAX

Where it is running

• multiple sites: contact Central Study coordination — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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