StaphVAX Immunogenicity in Orthopedic Implant Patients
Phase 3
Completed
- Conditions
- Staphylococcal InfectionsJoint Prosthesis
- 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
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which StaphVAX® induces immune response against S. aureus capsular polysaccharides in orthopedic implant patients?
How does the immunogenicity of StaphVAX® compare to standard-of-care prophylactic antibiotics in preventing prosthetic joint infections?
Which biomarkers correlate with enhanced antibody production following StaphVAX® administration in individuals undergoing knee or hip arthroplasty?
What are the most common adverse events reported in phase 3 trials of StaphVAX® and how were they managed in orthopedic surgery contexts?
Are there any related staphylococcal vaccines or combination therapies currently in development for prosthetic implant-associated infections?
Trial Locations
- Locations (1)
Cllinical Research Asociates of Tidewater
🇺🇸Norfolk, Virginia, United States
Cllinical Research Asociates of Tidewater🇺🇸Norfolk, Virginia, United States