Joint Prosthesis, Staphylococcal Infections
Conditions
Keywords
vaccine, Staphylococcus aureus vaccine
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.
Interventions
single dose of vaccine containing 100 mcg of each serotype conjugate
BIOLOGICALplacebo
single dose of placebo
Sponsors
Nabi Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serotype-specific antibody concentrations | 6 weeks after dose |
Secondary
| Measure | Time frame |
|---|---|
| serotype-specific antibody concentrations | several other time points after dose, up to 365 days |
| safety: adverse events | 0-365 days |
Countries
United States
Outcome results
None listed