StaphVAX Immunogenicity in Orthopedic Implant Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Staphylococcal Infections, Joint Prosthesis

In brief

S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty.

Key facts

Study ID

NCT00211926

Run by

Nabi Biopharmaceuticals

People needed

120

Starts

2004-12-01

Expected to finish

2006-10-01

Last updated by the study team

2008-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age 18 years or older
• candidate for knee or hip replacement
• expectation of protocol compliance
• negative pregnancy test, where appropriate

You may not qualify if…

• known S. aureus infection in the prior 3 months
• infection in the prior 2 weeks
• Known HIV infection
• immunomodulatory drugs
• Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer)
• Hypersensitivity to components of StaphVAX

Where it is running

• Cllinical Research Asociates of Tidewater — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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