NCT00211965

StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adult Patients Receiving an Orthopedic Prosthetic Implant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Nabi Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Staphylococcus aureus (S. aureus) is the most common pathogen encountered in infections associated with orthopedic surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides 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 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 orthopedic surgery.

Conditions

• Staphylococcal Infections

Interventions

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

Timeline

• Start date: 2005-04-01
• Primary completion: 2006-05-01
• Completion: 2006-08-01
• First posted: 2005-09-21
• Last updated: 2008-01-04

Locations

1 site across 1 country: United Kingdom