StaphVAX Immunogenicity in Orthopedic Implant Patients
Phase 3
Completed
- Conditions
- Staphylococcal InfectionsJoint Prosthesis
- Interventions
- Biological: S. aureus Type 5 & 8 Capsular Polysaccharide ConjugateBiological: placebo
- Registration Number
- NCT00211926
- Lead Sponsor
- Nabi Biopharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description StaphVAX S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate - Placebo placebo -
- Primary Outcome Measures
Name Time Method serotype-specific antibody concentrations 6 weeks after dose
- Secondary Outcome Measures
Name Time Method serotype-specific antibody concentrations several other time points after dose, up to 365 days safety: adverse events 0-365 days
Trial Locations
- Locations (1)
Cllinical Research Asociates of Tidewater
🇺🇸Norfolk, Virginia, United States