StaphVAX in Cardiovascular Surgery Patients

Study Overview
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Brief Summary
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S. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) 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 during 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 cardiovascular 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 Undergoing Cardiovascular Surgery

Conditions
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Staphylococcal Infections, Cardiovascular Diseases, Cardiovascular Surgical Procedures

Intervention / Treatment
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* Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for cardiovascular surgery Expected to comply with protocol Negative pregnancy test where appropriate Written informed consent Exclusion Criteria: Known S. aureus infection in past 3 months Known infection in the past 2 weeks Known HIV infection Pregnancy or breast-feeding Immunomodulatory drugs Malignancy or treatment for malignancy within the past six months, other than basal cell, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or early stage prostate cancer investigational drugs, vaccines or products in the past 30 days 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 of StaphVAX® | Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate<br>* single IM dose totalling 200 mcg of conjugate<br>* Other names: StaphVAX®;|
| Placebo Comparator: placebo<br>single dose | Biological: placebo<br>* single IM dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific antibody concentrations |  | 6 weeks after the vaccine dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific antibody concentrations |  | at other time points 7-180 days after the vaccine dose. | 
| adverse events |  | 0-180 days after vaccine dose |