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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
single IM dose totalling 200 mcg of conjugate
single IM dose
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Serotype-specific antibody concentrations
Time frame: 6 weeks after the vaccine dose
Serotype-specific antibody concentrations
Time frame: at other time points 7-180 days after the vaccine dose.
adverse events
Time frame: 0-180 days after vaccine dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.