StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

Study Overview
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Brief Summary
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Staphylococcus aureus (S. aureus) is the most common pathogen encountered in infections associated with orthopedic surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for orthopedic surgery.

Official Title
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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 Orthopedic Prosthetic Implant

Conditions
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Staphylococcal Infections

Intervention / Treatment
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* Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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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 prostate cancer) Hypersensitivity to components of StaphVAX

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaccine<br>single dose | Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate<br>* single IM dose of 200 mcg total conjugate<br>* Other names: StaphVAX®;|
| Placebo Comparator: placebo<br>single dose | Biological: placebo<br>* single dose IM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sero-type specific antibody concentrations |  | 6 weeks after study dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sero-type specific antibody concentrations |  | various other time points after study dose, up to 26 wk | 
| adverse events |  | throughout 6 months observation after study dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee replacement surgery, hip replacement surgery, nosocomial infections, Arthroplasty