StaphVAX in Cardiovascular Surgery Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Staphylococcal Infections, Cardiovascular Diseases, Cardiovascular Surgical Procedures

In brief

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.

Key facts

Study ID

NCT00211913

Run by

Nabi Biopharmaceuticals

People needed

120

Starts

2004-06-01

Expected to finish

2006-01-01

Last updated by the study team

2008-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Candidate for cardiovascular surgery
• Expected to comply with protocol
• Negative pregnancy test where appropriate
• Written informed consent

You may not qualify if…

• 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

Where it is running

• Clinical Research Associates of Tidewater — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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