StaphVAX in Cardiovascular Surgery Patients

Phase 3

Completed

• Conditions: Staphylococcal Infections; Cardiovascular Surgical Procedures; Cardiovascular Diseases
• Interventions: Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate; Biological: placebo

• Registration Number: NCT00211913
• Lead Sponsor: Nabi Biopharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2005-10
• Study Completion: 2006-01
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-26
• Last Update Posted: 2008-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vaccine	S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate	single dose of StaphVAX®
placebo	placebo	single dose

Primary Outcome Measures

Name	Time	Method
Serotype-specific antibody concentrations	6 weeks after the vaccine dose

Secondary Outcome Measures

Name	Time	Method
adverse events	0-180 days after vaccine dose
Serotype-specific antibody concentrations	at other time points 7-180 days after the vaccine dose.

Trial Locations

Locations (1)

Clinical Research Associates of Tidewater; 🇺🇸 Norfolk, Virginia, United States