StaphVAX in Cardiovascular Surgery Patients

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

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.

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