NCT00211913

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Nabi Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Staphylococcal Infections
• Cardiovascular Diseases
• Cardiovascular Surgical Procedures

Interventions

Type	Name	Description
BIOLOGICAL	S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate	single IM dose totalling 200 mcg of conjugate
BIOLOGICAL	placebo	single IM dose

Timeline

• Start date: 2004-06-01
• Primary completion: 2005-10-01
• Completion: 2006-01-01
• First posted: 2005-09-21
• Last updated: 2008-01-04

Locations

1 site across 1 country: United States