StaphVAX Immunogenicity in Orthopedic Implant Patients

A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Receiving an Orthopaedic Prosthetic Implant

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.

Inclusion Criteria:

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

Exclusion Criteria:

• 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